91 Matching Annotations
  1. Sep 2019
    1. Glucose AssessmentFor many people with diabetes, glucose monitoring is key for the achievement of glycemic targets. Major clinical trials of insulin-treated patients have included SMBG as part of multifactorial interventions to demonstrate the benefit of intensive glycemic control on diabetes complications (16). SMBG is thus an integral component of effective therapy of patients taking insulin. In recent years, CGM has emerged as a complementary method for the assessment of glucose levels. Glucose monitoring allows patients to evaluate their individual response to therapy and assess whether glycemic targets are being safely achieved. Integrating results into diabetes management can be a useful tool for guiding medical nutrition therapy and physical activity, preventing hypoglycemia, and adjusting medications (particularly prandial insulin doses). The patient’s specific needs and goals should dictate SMBG frequency and timing or the consideration of CGM use. Please refer to Section 7 “Diabetes Technology” for a fuller discussion of the use of SMBG and CGM.

      Based on the publication of recommendations from the clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range, a new table showing standardized CGM metrics for clinical care, and a new figure showing an example of an ambulatory glucose profile are included:

      NEW Table. Standardized CGM Metrics for Clinical Care, available at https://care.diabetesjournals.org/table_6.4_New

      NEW Figure. Ambulatory Glucose Profile (reprinted from Battelino et al.), available at https://care.diabetesjournals.org/content/diacare/42/8/1593/F2.large.jpg

      Reference: Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care 2019 Aug; 42(8): 1593-1603. https://doi.org/10.2337/dci19-0028

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S61–S70. Retrieved at https://hyp.is/hQ0b7rO6Eemy96878HFnAg/care.diabetesjournals.org/content/42/Supplement_1/S61

  2. Aug 2019
    1. For patients with type 2 diabetes and CKD, the selection of specific agents may depend on comorbidity and CKD stage. SGLT2 inhibitors may be more useful for patients at high risk of CKD progression (i.e., with albuminuria or a history of documented eGFR loss) (Fig. 9.1) because they appear to have large beneficial effects on CKD incidence. Empagliflozin and canagliflozin are only approved by the FDA for use with eGFR ≥45 mL/min/1.73 m2 (though pivotal trials for each included participants with eGFR ≥30 mL/min/1.73 m2 and demonstrated benefit in subgroups with low eGFR) (18,19), and dapagliflozin is only approved for eGFR ≥60 mL/min/1.73 m2. Some GLP-1 RA may be used with lower eGFR and may have greater benefits for reduction of ASCVD than for CKD progression or heart failure.

      Based on a revision to the prescribing information for dapagliflozin in 2019, the approved use per eGFR is revised from ≥60 mL/min/1.73 m2 to ≥45 mL/min/1.73 m2

      "For patients with type 2 diabetes and CKD, the selection of specific agents may depend on comorbidity and CKD stage. SGLT2 inhibitors may be more useful for patients at high risk of CKD progression (i.e., with albuminuria or a history of documented eGFR loss) (Fig. 9.1) because they appear to have large beneficial effects on CKD incidence. Empagliflozin and canagliflozin are only approved by the FDA for use with eGFR ≥45 mL/min/1.73 m2 (though pivotal trials for each include participants with eGFR ≥30 mL/min/1.73 m2 and demonstrated benefit in subgroups with low eGFR) (18,19), and the label for dapagliflozin was recently modified to also allow for use with an eGFR ≥45 mL/min/1.73 m2. Some GLP-1 RA may be used with lower eGFR and may have greater benefits for reduction of ASCVD than for CKD progression or heart failure."

      Reference: Farxiga [prescribing information]. February 2019. Available at: https://www.azpicentral.com/farxiga/farxiga.pdf#page=1

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/0KQJBFCwEem4F5t0qDXZoQ/care.diabetesjournals.org/content/42/Supplement_1/S124

    2. Important caveats limit the strength of evidence supporting the recommendation of SGLT2 inhibitors and GLP-1 RA in patients with type 2 diabetes and CKD. As noted above, published data address a limited group of CKD patients, mostly with coexisting ASCVD. Renal events have been examined primarily as secondary outcomes in published large trials. Also, adverse event profiles of these agents must be considered. Please refer to Table 9.1 for drug-specific factors, including adverse event information, for these agents. Therefore, additional clinical trials are needed to more rigorously assess the benefits and risks of these classes of drugs among people with CKD.

      Based on findings from the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, the 8th paragraph of the sub-section “Selection of Glucose-Lowering Medications for Patients with Chronic Kidney Disease” has been edited to acknowledge findings from CREDENCE:

      "Findings from CREDENCE provide important evidence that canagliflozin use in patients with type 2 diabetes and albuminuric (UACR >300 mg/g) DKD decreased the risk of the renal-specific composite outcome (inclusive of ESKD, doubling of the creatinine level, or death from renal causes) by an additional 34% over standard of care with over 99% of people being on a renin angiotensin system blocker with good BP and glycemic control. Moreover, there were significant reductions in cardiovascular events, including MACE and hospitalizations for heart failure (Perkovic 2019). Although the adverse event profiles of these agents must be considered, the risk-benefit balance of SGLT-2 inhibitor treatment appears to be favorable for most patients with type 2 diabetes and CKD. Please refer to Table 9.1 for drug-specific factors, including adverse event information, for these agents. Clinical trials currently in progress will provide additional insight into the benefits and risks of these classes of drugs among people with CKD."

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published: June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/ytTBiIYdEemho3NXeenm7g/care.diabetesjournals.org/content/42/Supplement_1/S124

    3. Several large clinical trials of SGLT2 inhibitors focused on patients with CKD, and assessment of primary renal outcomes are completed or ongoing. Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), a placebo-controlled trial of canagliflozin among 4,401 adults with type 2 diabetes, UACR ≥300 mg/g, and eGFR 30–90 mL/min/1.73 m2, has a primary composite end point of ESRD, doubling of serum Cr, or renal or cardiovascular death (54). It was stopped early due to positive efficacy, with detailed results expected in 2019.

      Based on findings from the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, the 6th paragraph of the sub-section “Selection of Glucose-Lowering Medications for Patients with Chronic Kidney Disease” has been edited to update the existing paragraph discussing the CREDENCE trial:

      "Several large clinical trials of SGLT2 inhibitors focused on patients with CKD, and assessment of primary renal outcomes are completed or ongoing. Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), a placebo-controlled trial of canagliflozin among 4,401 adults with type 2 diabetes, UACR ≥300 mg/g, and EGFR 30-90 mL/min/1.73 m2, had a primary composite end point of ESRD, doubling of serum Cr, or renal or cardiovascular death (54; Perkovic 2019). CREDENCE was stopped early following a planned interim analysis due to conclusive evidence of efficacy. The risk of the primary composite outcome was 30% lower with canagliflozin treatment when compared with placebo (HR 0.70 [95% CI 0.59-0.82]). In addition, the risk of the renal-specific composite outcome of ESRD, doubling of serum Cr, and death from renal causes was lower by 34% in the canagliflozin group compared with placebo (HR 0.66 [95% CI 0.53-0.81]). Importantly, the renal and cardiovascular risk reduction observed in CREDENCE was present in patients with an eGFR in the 30-45 ml/min/1.73 m2 range. Although the adverse event profiles of these agents must be considered, the risk-benefit balance of SGLT-2 inhibitor treatment appears to be favorable for most patients with type 2 diabetes and CKD. No increased risk of lower-limb amputations, fractures, acute kidney injury, or hyperkalemia were noted for canagliflozin relative to placebo in CREDENCE. An increased risk for diabetic ketoacidosis (DKA) was noted, however, with 2.2 and 0.2 events per 1000 patient-years noted in the canagliflozin and placebo groups, respectively (HR 10.80 [95% CI 1.39-83.65]) (Perkovic 2019). Please refer to Table 9.1 for drug-specific factors, including adverse event information, for these agents."

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published: June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/ZjRG9IYdEemNvbOMQ928jw/care.diabetesjournals.org/content/42/Supplement_1/S124

    4. A number of large cardiovascular outcomes trials in patients with type 2 diabetes at high risk for CVD or with existing CVD examined kidney effects as secondary outcomes. These trials include EMPA-REG OUTCOME [BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients], CANVAS (Canagliflozin Cardiovascular Assessment Study), LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results), and SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes) (42,44,47,51). Specifically, compared with placebo, empagliflozin reduced the risk of incident or worsening nephropathy (a composite of progression to UACR >300 mg/g Cr, doubling of serum Cr, ESRD, or death from ESRD) by 39% and the risk of doubling of serum Cr accompanied by eGFR ≤45 mL/min/1.73 m2 by 44%; canagliflozin reduced the risk of progression of albuminuria by 27% and the risk of reduction in eGFR, ESRD, or death from ESRD by 40%; liraglutide reduced the risk of new or worsening nephropathy (a composite of persistent macroalbuminuria, doubling of serum Cr, ESRD, or death from ESRD) by 22%; and semaglutide reduced the risk of new or worsening nephropathy (a composite of persistent UACR >300 mg/g Cr, doubling of serum Cr, or ESRD) by 36% (each P < 0.01).

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, the section "Selection of Glucose-Lowering Medications for Patients with Chronic Kidney Disease" has been updated to incorporate findings from the trial. The highlighted portion of the section is officially updated to the following:

      "A number of large cardiovascular outcomes trials in patients with type 2 diabetes at high risk for CVD or with existing CVD examined kidney effects as secondary outcomes. These trials include EMPA-REG Outcome [BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients], CANVAS (Canagliflozin Cardiovascular Assessment Study), DECLARE-TIMI 58 (The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58) Trial, LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results), and SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes) (42,44,47,51, DECLARE-TIMI 58). Specifically, compared with placebo, empagliflozin reduced the risk of incident or worsening nephropathy (a composite of progression to UACR >300 mg/g Cr, doubling of serum Cr, ESRD, or death from ESRD) by 39% and the risk of doubling of serum Cr accompanied by eGFR ≤45 mL/min/1.73 m2 by 44%; canagliflozin reduced the risk of progression of albuminuria by 27% and the risk of reduction in eGFR, ESRD, or death from ESRD by 40%; dapagliflozin treatment resulted in a lower rate of renal events, defined as a composite of ≥40% decrease in eGFR to <60 mL/min/1.73 m2, ESRD, or death from renal cause, by 47% compared to placebo; liraglutide reduced the risk of new or worsening nephropathy (a composite of persistent macro-albuminuria, doubling of serum Cr, ESRD, or death from ESRD) by 225; and semaglutide reduced the risk of new or worsening nephropathy (a composite of persistent UACR >300 mg/g Cr, doubling of serum Cr, or ESRD) by 36% (each P < 0.01, with the exception of dapagliflozin which was an hypothesis-generating finding)."

      Reference:

      Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/rNDuylCwEemQKtcV9imqsg/care.diabetesjournals.org/content/42/Supplement_1/S124

    5. 11.8 Continued monitoring of urinary albumin-to-creatinine ratio in patients with albuminuria treated with an ACE inhibitor or an angiotensin receptor blocker is reasonable to assess the response to treatment and progression of chronic kidney disease. E

      Based on findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, recommendation 11.8 is no longer a recommendation.

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published: June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/5CuDDIYcEemYCk9NBpUFHg/care.diabetesjournals.org/content/42/Supplement_1/S124

    6. 11.3 For patients with type 2 diabetes and chronic kidney disease, consider use of a sodium–glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist shown to reduce risk of chronic kidney disease progression, cardiovascular events, or both (Table 9.1). C

      Based on findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, recommendation 11.3 has been edited and the evidence ratings for SGLT2 inhibitor and GLP-1 receptor agonist use are now differentiated.

      11.3 For patients with type 2 diabetes and diabetic kidney disease, consider use of a sodium-glucose cotransporter 2 inhibitor in patients with an eGFR ≥30 and particularly in those with >300 mg/g albuminuria to reduce risk of CKD progression, cardiovascular events, or both. A In patients with CKD who are at increased risk for CV events, use of a glucagon-like peptide 1 receptor agonist may reduce risk of progression of albuminuria, cardiovascular events, or both (Table 9.1). C

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published: June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/lunvAoYcEemfUbsq6AUjsA/care.diabetesjournals.org/content/42/Supplement_1/S124

    7. 11.1 At least once a year, assess urinary albumin (e.g., spot urinary albumin-to-creatinine ratio) and estimated glomerular filtration rate in patients with type 1 diabetes with duration of ≥5 years, in all patients with type 2 diabetes, and in all patients with comorbid hypertension. B

      With the removal of recommendation 11.8 (as noted below) and in consideration of findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, recommendation 11.1 has been revised:

      11.1 At least once a year, assess urinary albumin (e.g., spot urinary albumin-to-creatine ratio) and estimated glomerular filtration rate in patients with type 1 diabetes with duration of ≥5 years, in all patients with type 2 diabetes, regardless of treatment, and in all patients with comorbid hypertension. B

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published: June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/TOPiyIYcEemWzwsTRKvcLA/care.diabetesjournals.org/content/42/Supplement_1/S124

    8. 11. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of June 3, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards

    1. When insulin treatment is not required, initiation of metformin is recommended. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study found that metformin alone provided durable glycemic control (A1C ≤8% [64 mmol/mol] for 6 months) in approximately half of the subjects (148). To date, the TODAY study is the only trial combining lifestyle and metformin therapy in youth with type 2 diabetes; the combination did not perform better than metformin alone in achieving durable glycemic control (148).

      The sixth paragraph of the “Management” sub-section of Type 2 Diabetes within Section 13. Children and Adolescents has been expanded to acknowledge the recent approval of liraglutide for use in patients ≥10 years of age (see 2019 Standards of Care pages S157-S158):

      "When insulin treatment is not required, initiation of metformin is recommended. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study found that metformin alone provided durable glycemic control (A1C ≤8% [64 mmol/mol] for 6 months) in approximately half of the subjects (148). To date, the TODAY study is the only trial combining lifestyle and metformin therapy in youth with type 2 diabetes; the combination did not perform better than metformin alone in achieving durable glycemic control (148). Liraglutide is approved by the FDA for the treatment of type 2 diabetes in patients ≥10 years of age based on a trial demonstrating improved glycemic control and lower weight when used in patients 10 to <17 years of age in combination with metformin (Victoza PI; Tamborlane 2019)"

      New References: Liraglutide (Victoza) [package insert]. June 2019. Novo Nordisk, Inc.

      Tamborlane WV, Barrientos-Pérez M, Fainberg U, et al. Liraglutide in children and adolescents with type 2 diabetes. N Engl J Med 2019 Apr 28. Doi: 10.1056/NEJMoa1903822. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes 2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S148–S164. Retrieved from https://hyp.is/Y_YB5LO3EemSVzcxGrBZYw/care.diabetesjournals.org/content/42/Supplement_1/S148

    2. Current pharmacologic treatment options for youth-onset type 2 diabetes are limited to two approved drugs—insulin and metformin (2).

      The first sentence of the fifth paragraph of the “Management” sub-section of Type 2 Diabetes within Section 13. Children and Adolescents has been edited to acknowledge the recent approval of liraglutide for use in patients ≥10 years of age (see 2019 Standards of Care page S157):

      "Current pharmacologic treatment options for youth-onset type 2 diabetes are limited to three approved drugs – insulin, metformin, and liraglutide (2; Victoza PI)."

      References: Liraglutide (Victoza) [package insert]. June 2019. Novo Nordisk, Inc.

      Tamborlane WV, Barrientos-Pérez M, Fainberg U, et al. Liraglutide in children and adolescents with type 2 diabetes. N Engl J Med 2019 Apr 28. Doi: 10.1056/NEJMoa1903822. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes 2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S148–S164. Retrieved from https://hyp.is/Eg5WiLO3EempPI8X0o_e3Q/care.diabetesjournals.org/content/42/Supplement_1/S148

    3. 13.63 If the A1C target is no longer met with metformin monotherapy, or if contraindications or intolerable side effects of metformin develop, basal insulin therapy should be initiated. B

      Based on the approval of liraglutide for type 2 diabetes in people ≥10 years of age, recommendation 13.63 (2019 SOC page S156) has been revised:

      "13.63 If glycemic targets are no longer met with metformin ± basal insulin, liraglutide therapy should be considered in children 10 years or older, if no history or family history of medullary thyroid carcinoma or MEN2. A"

      References: Liraglutide (Victoza) [package insert]. June 2019. Novo Nordisk, Inc.

      Tamborlane WV, Barrientos-Pérez M, Fainberg U, et al. Liraglutide in children and adolescents with type 2 diabetes. N Engl J Med 2019 Apr 28. Doi: 10.1056/NEJMoa1903822. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes 2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S148–S164. Retrieved from https://hyp.is/oEM07LO2Eem2ngOddV1RAQ/care.diabetesjournals.org/content/42/Supplement_1/S148

    1. Cardiovascular outcomes trials of available antihyperglycemic medications completed after the issuance of the FDA 2008 guidelines

      Based on findings from the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, Table 10.4 has been updated:

      https://care.diabetesjournals.org/content/table-104-amendment

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/oY6ABLPKEem0eftk0K4w8w/care.diabetesjournals.org/content/42/Supplement_1/S103

    2. Cardiovascular outcomes trials of available antihyperglycemic medications completed after the issuance of the FDA 2008 guidelines

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, Table 10.4 has been updated to incorporate findings from the trial into the SGLT2 inhibitor section of the table. The following data table amendment summarizes findings from the study:

      Table 10.4 Updates

      Reference: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/7BhK6lCtEemVUCM9NgLcpg/care.diabetesjournals.org/content/42/Supplement_1/S103

    3. A benefit on the incidence of heart failure has been observed with the use of some SGLT2 inhibitors. In EMPA-REG OUTCOME, the addition of empagliflozin to standard care led to a significant 35% reduction in hospitalization for heart failure compared with placebo (8). Although the majority of patients in the study did not have heart failure at baseline, this benefit was consistent in patients with and without a prior history of heart failure (172). Similarly, in CANVAS, there was a 33% reduction in hospitalization for heart failure with canagliflozin versus placebo (9). Although heart failure hospitalizations were prospectively adjudicated in both trials, the type(s) of heart failure events prevented were not characterized. These preliminary findings, which strongly suggest heart failure–related benefits of SGLT2 inhibitors (particularly the prevention of heart failure), are being followed up with new outcomes trials in patients with established heart failure, both with and without diabetes, to determine their efficacy in treatment of heart failure.

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, the "Antihyperglycemic Therapies and Heart Failure" section was updated to include the heart failure outcomes reported for the trial.

      Also, this has been edited to briefly add hospitalization for HF data from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial.

      The highlighted paragraph has been edited to read:

      "Reduced incidence of heart failure has been observed with the use of SGLT2 inhibitors. In EMPA-REG OUTCOME, the addition of empagliflozin to standard care led to a significant 35% reduction in hospitalization for heart failure compared with placebo (8). Although the majority of patients in the study did not have heart failure at baseline, this benefit was consistent in patients with and without a history of heart failure (172). Similarly, in CANVAS and DECLARE-TIMI 58, there were 33% and 27% reductions in hospitalization for heart failure, respectively, with SGLT2 inhibitor use versus placebo (9, DECLARE-TIMI 58). Additional data from the CREDENCE trial with canagliflozin showed a 39% reduction in hospitalization for heart failure, and 31% reduction in the composite of cardiovascular death or hospitalization for heart failure, in a diabetic kidney disease population with albuminuria (UACR of >300 to 5000 mg/g) (Perkovic 2019). These combined findings from four large outcomes trials of three different SGLT-2 inhibitors are highly consistent, and clearly indicate robust benefits of SGLT2 inhibitors in the prevention of heart failure hospitalizations. They also suggest (but do not prove) that SGLT-2 inhibitors may be beneficial in patients with established HF. This hypothesis is being specifically evaluated in several large outcome trials in patients with established heart failure, both with and without diabetes, to determine the efficacy of SGLT-2 inhibitors in the treatment of heart failure with reduced and preserved ejection fraction."

      References: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      DECLARE-TIMI 58 annotation published: March 27, 2019.

      DECLARE-TIMI 58 annotation approved by PPC: March 13, 2019.

      CREDENCE annotation published: June 3, 2019

      CREDENCE annotation approved by PPC: May 26, 2019

      CREDENCE annotation approved by ACC designated representatives: May 31, 2019

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/T2YPwlCwEemZtu-iVcmQig/care.diabetesjournals.org/content/42/Supplement_1/S103

    4. A second large cardiovascular outcomes trial program of an SGLT2 inhibitor, canagliflozin, has been reported (9). The Canagliflozin Cardiovascular Assessment Study (CANVAS) integrated data from two trials, including the CANVAS trial that started in 2009 before the approval of canagliflozin and the CANVAS-Renal (CANVAS-R) trial that started in 2014 after the approval of canagliflozin. Combining both these trials, 10,142 participants with type 2 diabetes (two-thirds with established CVD) were randomized to canagliflozin or placebo and were followed for an average 3.6 years. The mean age of patients was 63 years and 66% had a history of cardiovascular disease. The combined analysis of the two trials found that canagliflozin significantly reduced the composite outcome of cardiovascular death, MI, or stroke versus placebo (occurring in 26.9 vs. 31.5 participants per 1,000 patient-years; HR 0.86 [95% CI 0.75–0.97]; P < 0.001 for noninferiority; P = 0.02 for superiority). The specific estimates for canagliflozin versus placebo on the primary composite cardiovascular outcome were HR 0.88 (0.75–1.03) for the CANVAS trial and 0.82 (0.66–1.01) for CANVAS-R, with no heterogeneity found between trials. In the combined analysis, there was not a statistically significant difference in cardiovascular death (HR 0.87 [95% CI 0.72–1.06]). The initial CANVAS trial was partially unblinded prior to completion because of the need to file interim cardiovascular outcomes data for regulatory approval of the drug (158). Of note, there was an increased risk of lower-limb amputation with canaglifozin (6.3 vs. 3.4 participants per 1,000 patient-years; HR 1.97 [95% CI 1.41–2.75]) (9).

      The third paragraph of the sub-section “Antihyperglycemic Therapies and Cardiovascular Outcomes” has been edited and lengthened to incorporate findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial.

      "Two large outcome trials of the SGLT2 inhibitor canagliflozin have been conducted, which separately assessed the cardiovascular effects of treatment in patients at high risk for major adverse cardiovascular events, and the impact of canagliflozin therapy on cardiorenal outcomes in patients with diabetes-related chronic kidney disease. First, the Canagliflozin Cardiovascular Assessment Study (CANVAS) program integrated data from two trials. The CANVAS trial that started in 2009 was partially unblinded prior to completion because of the need to file interim cardiovascular outcomes data for regulatory approval of the drug (158). Thereafter, the post-approval CANVAS-Renal (CANVAS-R) trial was started in 2014. Combining both of these trials, 10,142 participants with type 2 diabetes were randomized to canagliflozin or placebo and were followed for an average 3.6 years. The mean age of patients was 63 years and 66% had a history of cardiovascular disease. The combined analysis of the two trials found that canagliflozin significantly reduced the composite outcome of cardiovascular death, MI, or stroke versus placebo (occurring in 26.9 vs. 31.5 participants per 1,000 patient-years; HR 0.86 [95% CI 0.75-0.97]). The specific estimates for canagliflozin versus placebo on the primary composite cardiovascular outcome were HR 0.88 (0.75-1.03) for the CANVAS trial and 0.82 (0.66-1.01) for CANVAS-R, with no heterogeneity found between trials. Of note, there was an increased risk of lower-limb amputation with canagliflozin (6.3 vs. 3.4 participants per 1,000 patient-years; HR 1.97 [95% CI 1.41-2.75]) (9). Second, the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial randomized 4,401 patients with type 2 diabetes and chronic diabetes-related kidney disease (UACR >300 mg/g, and eGFR 30 to <90 mL/min/1.73 m2) to canagliflozin 100 mg daily or placebo (Perkovic 2019). The primary outcome was a composite of end-stage kidney disease (ESKD), doubling of serum Cr, or death from renal or cardiovascular causes. The trial was stopped early due to conclusive evidence of efficacy identified during a pre-specified interim analysis with no unexpected safety signals. The risk of the primary composite outcome was 30% lower with canagliflozin treatment when compared with placebo (HR 0.70 [95% CI 0.59-0.82]). Moreover, it reduced the prespecified endpoint of ESKD alone by 32% (HR=0.68 [95%CI 0.54-0.86]). Canagliflozin was additionally found to have a lower risk of the composite of cardiovascular death, myocardial infarction, or stroke (HR 0.80 [95% CI 0.67-0.95]), as well as lower risk of hospitalizations for heart failure (HR 0.61 [95% CI 0.47-0.80]), and of the composite of cardiovascular death or hospitalization for heart failure (HR 0.69 [95% CI 0.57-0.83]). In terms of safety, no significant increase in lower-limb amputations, fractures, acute kidney injury, or hyperkalemia were noted for canagliflozin relative to placebo in CREDENCE. An increased risk for diabetic ketoacidosis (DKA) was noted, however, with 2.2 and 0.2 events per 1,000 patient-years noted in the canagliflozin and placebo groups, respectively (HR 10.80 [95% CI 1.39-83.65]) (Perkovic 2019). Please refer to Table 9.1 for drug-specific factors, including adverse event information, for these agents."

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published: June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Annotation approved by ACC designated representatives: May 31, 2019

      Suggested Citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/NsYojIYZEemFnI_DEXMccQ/care.diabetesjournals.org/content/42/Supplement_1/S103

    5. Antihyperglycemic Therapies and Cardiovascular Outcomes

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, the "Antihyperglycemic Therapies and Cardiovascular Outcomes" section is officially updated to summarize the cardiovascular outcomes reported for the trial. The following paragraph has been added to the narrative describing SGLT2 inhibitor CVOT findings:

      "The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) trial was another randomized, double-blind trial that assessed the effects of dapagliflozin versus placebo on cardiovascular and renal outcomes in 17,160 patients with type 2 diabetes and established atherosclerotic cardiovascular disease or multiple risk factors for atherosclerotic cardiovascular disease (DECLARE-TIMI 58). Study participants had a mean age of 64 years, with approximately 40% of study participants having established atherosclerotic cardiovascular disease at baseline – a characteristic of this trial that differs from other large cardiovascular trials where a majority of participants had established cardiovascular disease. DECLARE-TIMI 58 met the prespecified criteria for noninferiority to placebo with respect to MACE, but did not show a lower rate of MACE when compared to placebo (8.8% in the dapagliflozin group and 9.4% in the placebo group; HR 0.93; 95% CI 0.84-1.03; P=0.17). A lower rate of cardiovascular death or hospitalization for heart failure was noted (4.9% vs. 5.8%; HR 0.83; 95% CI 0.73-0.95; P=0.005), which reflected a lower rate of hospitalization for heart failure (HR 0.73; 95% CI 0.61-0.88). No difference was seen in cardiovascular death between groups."

      Reference: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/z8a74lCtEemihrPeflzSfA/care.diabetesjournals.org/content/42/Supplement_1/S103

    6. Hypertriglyceridemia should be addressed with dietary and lifestyle changes including weight loss and abstinence from alcohol (98). Severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL and especially >1,000 mg/dL) may warrant pharmacologic therapy (fibric acid derivatives and/or fish oil) to reduce the risk of acute pancreatitis. In addition, if 10-year ASCVD risk is ≥7.5%, it is reasonable to initiate moderate-intensity statin therapy or increase statin intensity from moderate to high. In patients with moderate hypertriglyceridemia, lifestyle interventions, treatment of secondary factors, and avoidance of medications that might raise triglycerides are recommended.

      Based on findings from the Reduction of Cardiovascular Event with Icosapent Ethyl-Intervention Trial (REDUCE-IT), an additional paragraph has been added to the "Treatment of Other Lipoprotein Fractions or Targets." The added paragraph follows the highlighted paragraph and reads:

      "The REDUCE-IT trial enrolled 8179 statin-treated adults with moderately elevated triglycerides (135-499 mg/dL, median baseline of 216 mg/dL) who had either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus plus at least one other CV risk factor (primary prevention cohort). Patients were randomized to icosapent ethyl 4 grams/day (2 grams twice daily with food) versus placebo. The trial met its primary endpoint demonstrating a 25% relative risk reduction (p<0.001) for the primary endpoint composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was reduced by 26%, (p<0.001). Additional ischemic end points, were significantly lower in the icosapent ethyl group than in the placebo group, including cardiovascular death, which was reduced by 20%, (p = 0.03). The proportions of patients experiencing adverse events and serious adverse events were similar between the active and placebo treatment groups. It should be noted that data are lacking with other omega-3 fatty acids, and results of the REDUCE-IT trial should not be extrapolated to other products."

      Reference: Bhatt DL, Steg G, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med 2019;380:11-22.

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/ijNg7lCtEeml2NvFi5PNkw/care.diabetesjournals.org/content/42/Supplement_1/S103

    7. Recommendations

      Based on findings from the Reduction of Cardiovascular Event with Icosapent Ethyl-Intervention Trial (REDUCE-IT), an additional recommendation has been officially added to the section "Treatment of Other Lipoprotein Fractions or Targets." The new recommendation reads as follows:

      In patients with ASCVD or other cardiac risk factors on a statin with controlled LDL-C, but elevated triglycerides (135-499), the addition of icosapent ethyl should be considered to reduce cardiovascular risk. A

      Reference: Bhatt DL, Steg G, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med 2019;380:11-22.

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/JHhz_lCrEembFJ9LIVBZIw/care.diabetesjournals.org/content/42/Supplement_1/S103

    8. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards

      Updates to Section 10. Cardiovascular Disease and Risk Management have also been reviewed and approved by the American College of Cardiology, who officially endorse this section.

    9. Antihyperglycemic Therapies and Cardiovascular Outcomes

      Based on findings from the REWIND trial, the "Antihyperglycemic Therapies and Cardiovascular Outcomes" section (2019 Standards of Care pages S115-S116) has been updated to summarize the cardiovascular outcomes reported for the trial. The following paragraph has been added to the narrative describing GLP-1 receptor agonist CVOT findings:

      "The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial was a randomized, double-blind, placebo-controlled trial that assessed the effect of the once-weekly GLP-1 receptor agonist dulaglutide versus placebo on MACE in approximately 9,990 patients with type 2 diabetes at risk for cardiovascular events or with a history of cardiovascular disease (REWIND 2019). Study participants had a mean age of 66 years and a mean duration of diabetes of approximately 10 years. Approximately 32% of participants had prior history of atherosclerotic cardiovascular events at baseline. After a median follow-up of 5.4 years, the primary composite outcome of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes occurred in 12.0% and 13.4% of participants in the dulaglutide and placebo treatment groups, respectively (HR 0.88; 95% CI 0.79-0.99; P =0.026). These findings equated to incidence rates of 2.4 and 2.7 events per 100 person-years, respectively. The results were consistent across the subgroups of patients with and without prior history of CV events. All-cause mortality did not differ between groups (p=0.067)."

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC and ACC: July 26, 2019

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/UcygWrPKEemPniuEEQ03yw/care.diabetesjournals.org/content/42/Supplement_1/S103

    1. Cardiovascular Outcomes TrialsThere are now multiple large randomized controlled trials reporting statistically significant reductions in cardiovascular events in patients with type 2 diabetes treated with an SGLT2 inhibitor (empagliflozin, canagliflozin) or GLP-1 receptor agonist (liraglutide, semaglutide). In people with diabetes with established ASCVD, empagliflozin decreased a composite three-point major cardiovascular event (MACE) outcome and mortality compared with placebo (54). Similarly, canagliflozin reduced the occurrence of MACE in a group of subjects with, or at high risk for, ASCVD (55). In both of these trials, SGLT2 inhibitors reduced hospitalization for HF (54,55); this was a secondary outcome of these studies and will require confirmation in more defined populations. In people with type 2 diabetes with ASCVD or increased risk for ASCVD, the addition of liraglutide decreased MACE and mortality (56), and the closely related GLP-1 receptor agonist semaglutide also had favorable effects on cardiovascular end points in high-risk subjects (57). In these cardiovascular outcomes trials, empagliflozin, canagliflozin, liraglutide, and semaglutide all had beneficial effects on composite indices of CKD (54–57). See antihyperglycemic therapies and cardiovascular outcomes in Section 10 “Cardiovascular Disease and Risk Management” and Table 10.4 for a detailed description of these cardiovascular outcomes trials, as well as a discussion of how HF may impact treatment choices. See Section 11 “Microvascular Complications and Foot Care” for a detailed discussion on how CKD may impact treatment choices. Additional large randomized trials of other agents in these classes are ongoing.The subjects enrolled in the cardiovascular outcomes trials using empagliflozin, canagliflozin, liraglutide, and semaglutide had A1C ≥7%, and more than 70% were taking metformin at baseline. Moreover, the benefit of treatment was less evident in subjects with lower risk for ASCVD. Thus, extension of these results to practice is most appropriate for people with type 2 diabetes and established ASCVD who require additional glucose-lowering treatment beyond metformin and lifestyle management. For these patients, incorporating one of the SGLT2 inhibitors or GLP-1 receptor agonists that have been demonstrated to reduce cardiovascular events is recommended (Table 9.1).

      Based on findings from the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, the section “Cardiovascular Outcomes Trials” (see 2019 Standards of Care page S98) was updated to read:

      “There are now multiple large randomized controlled trials reporting statistically significant reductions in cardiovascular events in patients with type 2 diabetes treated with SGLT2 inhibitors (empagliflozin, canagliflozin) or GLP-1 receptor agonists (liraglutide, dulaglutide, semaglutide). In people with diabetes with established ASCVD, empagliflozin decreased a composite three-point major cardiovascular event (MACE) outcome and mortality compared with placebo (54). Similarly, canagliflozin reduced the occurrence of MACE in a group of subjects with, or at high risk for, ASCVD (55). Dapagliflozin, in contrast, did not reach statistical significance for MACE, but did show a significant lowering of cardiovascular death or hospitalization for heart failure, which reflected a lower rate of hospitalization for heart failure (DECLARE-TIMI 58). In all three of these trials, SGLT2 inhibitors reduced hospitalization for HF (54,55, DECLARE-TIMI 58); this was not a primary outcome of these studies. In people with type 2 diabetes with ASCVD or increased risk for ASCVD, the addition of liraglutide decreased MACE and CV-related mortality (56), and the closely related GLP-1 receptor agonist semaglutide also had favorable effects on MACE endpoint in high-risk subjects (albeit in a smaller trial with shorter follow up, and limited number of events) (57). Dulaglutide was also shown to decrease the risk of the primary composite outcome of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes in the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, which enrolled individuals aged at least 50 years with either a previous cardiovascular event (30% of the trial population), subclinical ASCVD, or cardiovascular risk factors (70% of the trial population). This benefit was consistent in the subgroups of patients both with and without prior CV event. In these cardiovascular outcomes trials, empagliflozin, canagliflozin, and dapagliflozin all had beneficial effects on composite of CKD progression, which included progression to end-stage kidney disease and renal death (54,55, DECLARE-TIMI 53). GLP-1 receptor agonists (including, liraglutide, dulaglutide, and semaglutide) reduced progression of albuminuria (56,57, REWIND). See ANTIHYPERGLYCEMIC THERAPIES AND CARDIOVASCULAR OUTCOMES in Section 10 “Cardiovascular Disease and Risk Management” and Table 10.4 for a detailed description of these cardiovascular outcomes trials, as well as a discussion of how HF may impact treatment choices. See Section 11 “Microvascular Complications and Foot Care” for a detailed discussion on how CKD may impact treatment choices. Additional large randomized trials of other agents in these classes are ongoing. Within many of these trials the benefit of treatment (in terms of MACE endpoints) was less pronounced in subjects with lower risk for ASCVD; however data from DECLARE-TIMI 58 and REWIND trials indicate that the CV benefits of SGLT2 inhibitors (in terms of reduction in the risk for heart failure hospitalization) and GLP-1 receptor agonists (in terms of lower risk of MACE) may extend to higher-risk type 2 diabetes patients in the primary prevention group. In addition, canagliflozin significantly reduced the risk of MACE events and hospitalization for HF in patients with diabetic kidney disease, regardless of prior ASCVD status. For patients at high risk for cardiovascular events due to established ASCVD or multiple risk factors for ASCVD (which may include diabetic kidney disease), incorporating one of the SGLT2 inhibitors or GLP-1 receptor agonists that have been demonstrated to reduce cardiovascular events is recommended (Table 9.1).”

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/MNMTmrO5EemHZrMC6TORaA/care.diabetesjournals.org/content/42/Supplement_1/S90

    2. Cardiovascular Outcomes TrialsThere are now multiple large randomized controlled trials reporting statistically significant reductions in cardiovascular events in patients with type 2 diabetes treated with an SGLT2 inhibitor (empagliflozin, canagliflozin) or GLP-1 receptor agonist (liraglutide, semaglutide). In people with diabetes with established ASCVD, empagliflozin decreased a composite three-point major cardiovascular event (MACE) outcome and mortality compared with placebo (54). Similarly, canagliflozin reduced the occurrence of MACE in a group of subjects with, or at high risk for, ASCVD (55). In both of these trials, SGLT2 inhibitors reduced hospitalization for HF (54,55); this was a secondary outcome of these studies and will require confirmation in more defined populations. In people with type 2 diabetes with ASCVD or increased risk for ASCVD, the addition of liraglutide decreased MACE and mortality (56), and the closely related GLP-1 receptor agonist semaglutide also had favorable effects on cardiovascular end points in high-risk subjects (57). In these cardiovascular outcomes trials, empagliflozin, canagliflozin, liraglutide, and semaglutide all had beneficial effects on composite indices of CKD (54–57). See antihyperglycemic therapies and cardiovascular outcomes in Section 10 “Cardiovascular Disease and Risk Management” and Table 10.4 for a detailed description of these cardiovascular outcomes trials, as well as a discussion of how HF may impact treatment choices. See Section 11 “Microvascular Complications and Foot Care” for a detailed discussion on how CKD may impact treatment choices. Additional large randomized trials of other agents in these classes are ongoing.The subjects enrolled in the cardiovascular outcomes trials using empagliflozin, canagliflozin, liraglutide, and semaglutide had A1C ≥7%, and more than 70% were taking metformin at baseline. Moreover, the benefit of treatment was less evident in subjects with lower risk for ASCVD. Thus, extension of these results to practice is most appropriate for people with type 2 diabetes and established ASCVD who require additional glucose-lowering treatment beyond metformin and lifestyle management. For these patients, incorporating one of the SGLT2 inhibitors or GLP-1 receptor agonists that have been demonstrated to reduce cardiovascular events is recommended (Table 9.1).

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, the "Cardiovascualr Outcomes Trials" section is officially updated to incorporate these new data. The highlighted section has been updated per the following:

      "There are now multiple large randomized controlled trials reporting statistically significant reductions in cardiovascular events in patients with type 2 diabetes treated with an SGLT2 inhibitor (empagliflozin, canagliflozin) or GLP-1 receptor agonist (liraglutide, semaglutide). In people with diabetes with established ASCVD, empagliflozin decreased a composite three-point major cardiovascular event (MACE) outcome and mortality compared with placebo (54). Similarly, canagliflozin reduced the occurrence of MACE in a group of subjects with, or at high risk for, ASCVD (55). Dapagliflozin, in contrast, did not reach statistical significance for MACE, but did show a significant lowering of cardiovascular death or hospitalization for heart failure, which reflected a lower rate of hospitalization for heart failure (DECLARE-TIMI 58). In all three of these trials, SGLT2 inhibitors reduced hospitalization for HF (54,55, DECLARE-TIMI 58); this was a secondary outcome of these studies. In people with type 2 diabetes with ACVD or increased risk for ASCVD, the addition of liraglutide decreased MACE and mortality (56), and the closely related GLP-1 receptor agonist semaglutide also had favorable effects on cardiovascular end points in high-risk subjects (57). In these cardiovascular outcomes trials, empagliflozin, canagliflozin, dapagliflozin, liraglutide, and semaglutide all had beneficial effects on composite indices of CKD (54-57, DECLARE-TIMI 53). See ANTIHYPERGLYCEMIC THERAPIES AND CARDIOVASCULAR OUTCOMES in Section 10 “Cardiovascular Disease and Risk Management” and Table 10.4 for a detailed description of these cardiovascular outcomes trials, as well as a discussion of how HF may impact treatment choices. See Section 11 “Microvascular Complications and Foot Care” for a detailed discussion on how CKD may impact treatment choices. Additional large randomized trials of other agents in these classes are ongoing. The subjects enrolled in the cardiovascular outcomes trials using empagliflozin, canagliflozin, liraglutide and semaglutide had A1C ≥7%, and more than 70% were taking metformin at baseline. The cardiovascular outcome trial with dapagliflozin, in contrast, enrolled subjects with an A1C ≥6.5% with more than 80% taking metformin at baseline. Moreover, the benefit of treatment was less evident in subjects with lower risk for ASCVD. Thus, extension of these results to practice is most appropriate for people with type 2 diabetes and established ASCVD who require additional glucose-lowering treatment beyond metformin and lifestyle management. For these patients, incorporating one of the SGLT2 inhibitors or GLP-1 receptor agonists that have been demonstrated to reduce cardiovascular events is recommended (Table 9.1)."

      Reference: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/jsTAhlCsEembh5N0A0d5Bw/care.diabetesjournals.org/content/42/Supplement_1/S90

    3. Glucose-lowering medication in type 2 diabetes: overall approach. For appropriate context, see Fig. 4.1. ASCVD, atherosclerotic cardiovascular disease; CKD, chronic kidney disease; CV, cardiovascular; CVD, cardiovascular disease; CVOTs, cardiovascular outcomes trials; DPP-4i, dipeptidyl peptidase 4 inhibitor; eGFR, estimated glomerular filtration rate; GLP-1 RA, glucagon-like peptide 1 receptor agonist; HF, heart failure; SGLT2i, sodium–glucose cotransporter 2 inhibitor; SU, sulfonylurea; TZD, thiazolidinedione. Adapted from Davies et al. (39).

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, which showed a reduction of hospitalization for heart failure and a reduction in progression of CKD, footnote #3 within Figure 9.1 is revised to read:

      "Empagliflozin, canagliflozin and dapagliflozin have shown reduction in HF and reduction in CKD progression in CVOTs"

      Reference: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published: March 27, 2019.

      Annotation approved by PPC: March 13, 2019.

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/jgq_5FCqEemiZmevyli3qw/care.diabetesjournals.org/content/42/Supplement_1/S90

    4. Glucose-lowering medication in type 2 diabetes: overall approach. For appropriate context, see Fig. 4.1. ASCVD, atherosclerotic cardiovascular disease; CKD, chronic kidney disease; CV, cardiovascular; CVD, cardiovascular disease; CVOTs, cardiovascular outcomes trials; DPP-4i, dipeptidyl peptidase 4 inhibitor; eGFR, estimated glomerular filtration rate; GLP-1 RA, glucagon-like peptide 1 receptor agonist; HF, heart failure; SGLT2i, sodium–glucose cotransporter 2 inhibitor; SU, sulfonylurea; TZD, thiazolidinedione. Adapted from Davies et al. (39).

      Based on findings from the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, Figure 9.1 (see 2019 Standards of Care page S94), the first footnote was updated to read:

      “Use a GLP-1 receptor agonist with known CVD benefits. Liraglutide is FDA approved to reduce the risk of MACE in adults with type 2 diabetes and established CVD; liraglutide and dulaglutide showed superiority for MACE outcomes in large CVOTs; semaglutide showed superiority for MACE outcomes in a safety CVOT. These results were primarily in patients with known ASCVD although there was consistent benefit in the dulaglutide trial in patients with and without established ASCVD.”

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 201.

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/kJZy8LO4Eemxq1_MxCPrLA/care.diabetesjournals.org/content/42/Supplement_1/S90

    5. Drug-specific and patient factors to consider when selecting antihyperglycemic treatment in adults with type 2 diabetes

      Based on findings from the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, the ASCVD section of the table for “GLP-1RAs” (Table 9.1) was updated to read:

      “Benefit: liraglutide, dulaglutide, semaglutide”

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/K_dKGLO4EemfOzvU8QxaNw/care.diabetesjournals.org/content/42/Supplement_1/S90

    6. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards

    7. Drug-specific and patient factors to consider when selecting antihyperglycemic treatment in adults with type 2 diabetes

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, which showed a reduction of hospitalization for heart failure with dapagliflozin treatment versus placebo (HR: 0.73; 95% CI: 0.61 to 0.88), the portion of the table highlighting benefit of SGLT-2 inhibitors for CHF is revised to read:

      "Benefit: empagliflozin†, canagliflozin, dapagliflozin"

      Reference: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/N27FGFCqEemVcYde8LJqFw/care.diabetesjournals.org/content/42/Supplement_1/S90

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, which showed a reduction in renal events (composite of ≥40% decrease in eGFR to <60 ml per minute per 1.73m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular cause) with dapagliflozin treatment versus placebo (HR: 0.76; 95% CI: 0.67 to 0.87), the portion of the figure highlighting benefit of SGLT-2 inhibitors for CHF is revised to read:

      "Benefit: empagliflozin, canagliflozin, dapagliflozin"

      Reference: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/N27FGFCqEemVcYde8LJqFw/care.diabetesjournals.org/content/42/Supplement_1/S90

      Annotations published: March 27, 2019.

      Annotations approved by PPC: March 13, 2019.

    1. The abundance of data provided by CGM offers opportunities to analyze patient data more granularly than was previously possible, providing additional information to aid in achieving glycemic targets. A variety of metrics have been proposed (62). As recently reported, the metrics may include: 1) average glucose; 2) percentage of time in hypoglycemic ranges, i.e., <54 mg/dL (level 2), 54–70 mg/dL (level 1) (62); 3) percentage of time in target range, i.e., 70–180 mg/dL (3.9–9.9 mmol/L); 4) percentage of time in hyperglycemic range, i.e., ≥180 mg/dL (62). To make these metrics more actionable, standardized reports with visual cues, such as an ambulatory glucose profile (62), may help the patient and the provider interpret the data and use it to guide treatment decisions.

      Based on the clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range, the third paragraph of the sub-section ”Continuous Glucose Monitors” in Section 7. Diabetes Technology has been updated (see 2019 Standards of Care pages S74-S75), including the addition of a new Table and Figure of the Ambulatory Glucose Profile (AGP) in Section 6, Glycemic Targets:

      "The abundance of data provided by CGM offers opportunities to analyze patient data more granularly than was previously possible, providing additional information to aid in achieving glycemic targets. A variety of metrics have been proposed (62, Battelino 2019). As recently reported by an International Consensus on Time in Range (Battelino 2019), these metrics for clinical care of nonpregnant adults include: 1) average glucose; 2) percentage of time in hypoglycemic ranges, i.e., <54 mg/dL (level 2), 54-69 mg/dL (level 1) (62, Battelino 2019); 3) percentage of time in target range, i.e., 70-180 mg/dL (3.9-9.9 mmol/L); 4) percentage of time in hyperglycemic range, i.e., >250 mg/dL (level 2), 181-250 mg/dL (level 1) (62, Battelino 2019)."

      Reference: Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care 2019 Aug; 42(8): 1593-1603. https://doi.org/10.2337/dci19-0028

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S61–S70. Retrieved from https://hyp.is/AwM9trO8Eems-ocCn-jBtw/care.diabetesjournals.org/content/42/Supplement_1/S71

    2. 7. Diabetes Technology: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064.

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards.

    1. Glucose AssessmentFor many people with diabetes, glucose monitoring is key for the achievement of glycemic targets. Major clinical trials of insulin-treated patients have included SMBG as part of multifactorial interventions to demonstrate the benefit of intensive glycemic control on diabetes complications (16). SMBG is thus an integral component of effective therapy of patients taking insulin. In recent years, CGM has emerged as a complementary method for the assessment of glucose levels. Glucose monitoring allows patients to evaluate their individual response to therapy and assess whether glycemic targets are being safely achieved. Integrating results into diabetes management can be a useful tool for guiding medical nutrition therapy and physical activity, preventing hypoglycemia, and adjusting medications (particularly prandial insulin doses). The patient’s specific needs and goals should dictate SMBG frequency and timing or the consideration of CGM use. Please refer to Section 7 “Diabetes Technology” for a fuller discussion of the use of SMBG and CGM.

      Based on the publication of recommendations from the clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range, the “Glucose Assessment” sub-section in Section 6. Glycemic Targets has been updated to note recommended metrics:

      "For many people with diabetes, glucose monitoring is key for the achievement of glycemic targets. Major clinical trials of insulin-treated patients have included SMBG as part of multifactorial interventions to demonstrate the benefit of intensive glycemic control on diabetes complications (16). SMBG is thus an integral component of effective therapy of patients taking insulin. In recent years, CGM has emerged as a complementary method for the assessment of glucose levels. Glucose monitoring allows patients to evaluate their individual response to therapy and assess whether glycemic targets are being safely achieved. The International Consensus on Time in Range provides guidance on standardized CGM metrics (see NEW Table at https://care.diabetesjournals.org/table_6.4_New) and considerations for clinical interpretation and care (Battelino 2019). To make these metrics more actionable, standardized reports with visual cues, such as the Ambulatory Glucose Profile (see NEW Figure reprinted from Battelino et al. at https://care.diabetesjournals.org/content/diacare/42/8/1593/F2.large.jpg) are recommended (6 Battelino 2019) and may help the patient and the provider interpret the data and use it to guide treatment decisions. Integrating SMBG and CGM results into diabetes management can be a useful tool for guiding medical nutrition therapy and physical activity, preventing hypoglycemia, and adjusting medications. The patient’s specific needs and goals should dictate SMBG frequency and timing or the consideration of CGM use. Please refer to Section 7 ”Diabetes Technology” for a fuller discussion of the use of SMBG and CGM."

      Reference: Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care 2019 Aug; 42(8): 1593-1603. https://doi.org/10.2337/dci19-0028

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S61–S70. Retrieved from https://hyp.is/P8u3iLO7EemPZ5PkHZM4ww/care.diabetesjournals.org/content/42/Supplement_1/S61

    1. 10. CARDIOVASCULAR DISEASE AND RISK MANAGEMENT

      Based on findings from the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial, Table 10.4 of the complete Standards of Care has been updated:

      https://care.diabetesjournals.org/content/table-104-amendment

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019.

      Annotation approved by PPC: July 26, 2019.

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/7BhK6lCtEemVUCM9NgLcpg/care.diabetesjournals.org/content/42/Supplement_1/S103

    2. Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    1. Open Access 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    2. 13. Children and Adolescents: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    3. 11. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of June 3, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    4. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    5. 7. Diabetes Technology: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064.

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards.

    6. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2019

      This supplement contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    7. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of April 18, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    8. Table of Contents

      This supplement contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

  3. Jul 2019
    1. 10. CARDIOVASCULAR DISEASE AND RISK MANAGEMENT

      Based on findings from the REWIND trial, the "Antihyperglycemic Therapies and Cardiovascular Outcomes" section (see 2019 SoC pages S115-S116) has been updated to summarize the cardiovascular outcomes reported for the trial. The following paragraph has been added to the narrative describing GLP-1 receptor agonist CVOT findings:

      "The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial was a randomized, double-blind, placebo-controlled trial that assessed the effect of the once-weekly GLP-1 receptor agonist dulaglutide versus placebo on MACE in approximately 9,990 patients with type 2 diabetes at risk for cardiovascular events or with a history of cardiovascular disease (REWIND 2019). Study participants had a mean age of 66 years and a mean duration of diabetes of approximately 10 years. Approximately 32% of participants had prior history of atherosclerotic cardiovascular events at baseline. After a median follow-up of 5.4 years, the primary composite outcome of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes occurred in 12.0% and 13.4% of participants in the dulaglutide and placebo treatment groups, respectively (HR 0.88; 95% CI 0.79-0.99; P =0.026). These findings equated to incidence rates of 2.4 and 2.7 events per 100 person-years, respectively. The results were consistent across the subgroups of patients with and without prior history of CV events. All-cause mortality did not differ between groups (p=0.067)."

      Reference:

      Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotation approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123. Retrieved from https://hyp.is/urYG1rPMEem7VMfXHbNgmQ/clinical.diabetesjournals.org/content/37/1/11

    2. PHARMACOLOGIC APPROACHES TO GLYCEMIC TREATMENT

      In Table 9.1 (2019 Standards of Care page S93):

      The ASCVD section of the table for “GLP-1RAs” was updated to read: “Benefit: liraglutide, dulaglutide, semaglutide”

      In Figure 9.1 (2019 Standards of Care page S94), footnote 1 was updated to read:

      “Use a GLP-1 receptor agonist with known CVD benefits. Liraglutide is FDA approved to reduce the risk of MACE in adults with type 2 diabetes and established CVD; liraglutide and dulaglutide showed superiority for MACE outcomes in large CVOTs; semaglutide showed superiority for MACE outcomes in a safety CVOT. These results were primarily in patients with known ASCVD although there was consistent benefit in the dulaglutide trial in patients with and without established ASCVD.”

      Reference: Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019 Jun 7. Doi: 10.1016/S0140-6736(19)31150-X. [Epub ahead of print]

      Annotations published: July 31, 2019

      Annotations approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/QFq-4LPMEemsdGP8opkIhg/clinical.diabetesjournals.org/content/37/1/11

    3. Type 2 Diabetes

      The first sentence of the fifth paragraph of the “Management” sub-section of Type 2 Diabetes within Section 13. Children and Adolescents has been edited to acknowledge the recent approval of liraglutide for use in patients ≥10 years of age (page S157, 2019 Standards of Care):

      "Current pharmacologic treatment options for youth-onset type 2 diabetes are limited to three approved drugs—insulin, metformin, and liraglutide (2; Victoza PI)."

      The sixth paragraph of the “Management” sub-section of Type 2 Diabetes within Section 13. Children and Adolescents has been expanded to acknowledge the recent approval of liraglutide for use in patients ≥10 years of age (please see 2019 SoC pages S157-S158):

      "When insulin treatment is not required, initiation of metformin is recommended. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study found that metformin alone provided durable glycemic control (A1C ≤8% [64 mmol/mol] for 6 months) in approximately half of the subjects (148). To date, the TODAY study is the only trial combining lifestyle and metformin therapy in youth with type 2 diabetes; the combination did not perform better than metformin alone in achieving durable glycemic control (148). Liraglutide is approved by the FDA for the treatment of type 2 diabetes in patients ≥10 years of age based on a trial demonstrating improved glycemic control and lower weight when used in patients 10 to <17 years of age in combination with metformin (Victoza PI; Tamborlane 2019​)"

      Suggested citation: American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S148–S164. Retrieved from: https://hyp.is/i6sJ-rPLEemzB48zZgxEGw/clinical.diabetesjournals.org/content/37/1/11

    4. 13. CHILDREN AND ADOLESCENTSType 1 DiabetesRecommendations

      Based on the approval of liraglutide for type 2 diabetes in people ≥10 years of age, recommendation 13.63 (page S156, 2019 Standards of Care) has been revised:

      "13.63 If glycemic targets are no longer met with metformin ± basal insulin, liraglutide therapy should be considered in children 10 years or older, if no history or family history of medullary thyroid carcinoma or MEN2. A"

      References:

      Liraglutide (Victoza) [package insert]. June 2019. Novo Nordisk, Inc.

      Tamborlane WV, Barrientos-Pérez M, Fainberg U, et al. Liraglutide in children and adolescents with type 2 diabetes. N Engl J Med 2019 Apr 28. Doi: 10.1056/NEJMoa1903822. [Epub ahead of print]

      Annotation published: July 31, 2019

      Annotations approved by PPC: July 26, 2019

      Suggested citation: American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S148–S164. Retrieved from: https://hyp.is/TC3k0rPLEemtBH8QbJU67A/clinical.diabetesjournals.org/content/37/1/11

    1. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2019

      This supplement contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

    1. 13. Children and Adolescents: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of July 31, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards

  4. Jun 2019
    1. 11. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on June 3, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#June%203

    1. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on June 3, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#June%203

    1. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on March 27, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#March%2027,%202019

    1. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on April 18, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#April%2018,%202019

    1. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on April 18, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#April%2018,%202019

    2. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on June 3, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#June%203

    3. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on March 27, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#March%2027,%202019

    4. 11. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2019

      ADA issued an update to this section on June 3, 2019. Please access the most up-to-date information at: https://care.diabetesjournals.org/living-standards#June%203

    1. For patients with type 2 diabetes and CKD, consider use of an SGLT2 inhibitor or a GLP-1 receptor agonist shown to reduce risk of CKD progression, cardiovascular events, or both (Table 5). C

      Based on findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, recommendation 11.3 (in the complete version of the Standards of Care) has been edited and the evidence ratings for SGLT2 inhibitor and GLP-1 receptor agonist use are now differentiated.

      For patients with type 2 diabetes and diabetic kidney disease, consider use of a sodium-glucose cotransporter 2 inhibitor in patients with an eGFR ≥30 and particularly in those with >300 mg/g albuminuria to reduce risk of CKD progression, cardiovascular events, or both. A In patients with CKD who are at increased risk for CV events, use of a glucagon-like peptide 1 receptor agonist may reduce risk of progression of albuminuria, cardiovascular events, or both (Table 9.1). C

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/QmTeHoYiEemx8y95y0Axqg/clinical.diabetesjournals.org/content/37/1/11

    2. At least once a year, assess urinary albumin (e.g., spot urinary albumin-to-creatinine ratio) and eGFR in patients with type 1 diabetes with duration of ≥5 years, in all patients with type 2 diabetes, and in all patients with comorbid hypertension. B

      With the removal of recommendation 11.8 (in the full version of the Standards of Care) and in consideration of findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, this recommendation (11.1 in the full version of the Standards of Care) has been revised:

      At least once a year, assess urinary albumin (e.g., spot urinary albumin-to-creatine ratio) and estimated glomerular filtration rate in patients with type 1 diabetes with duration of ≥5 years, in all patients with type 2 diabetes, regardless of treatment, and in all patients with comorbid hypertension. B

      Reference: Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med 2019 April 14 [Epub ahead of print]. https://doi.org/10.1056/NEJMoa1811744

      Annotation published June 3, 2019.

      Annotation approved by PPC: May 26, 2019.

      Suggested citation: American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S124–S138. Retrieved from https://hyp.is/5gfrUoYhEemopUvLVfhBMw/clinical.diabetesjournals.org/content/37/1/11

  5. Apr 2019
    1. Eating Patterns, Macronutrient Distribution, and Meal PlanningEvidence suggests that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with diabetes. Therefore, macronutrient distribution should be based on an individualized assessment of current eating patterns, personal preferences (e.g., tradition, culture, religion, health beliefs and goals, economics), and metabolic goals.The Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and plant-based eating plans are examples of healthful eating patterns that have shown positive results in research. In addition, research indicates that low-carbohydrate eating plans may result in improved glycemia and have the potential to reduce antihyperglycemic medications for individuals with type 2 diabetes. There is inadequate research in type 1 diabetes to support one eating plan over another at this time.

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report," (http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014) the highlighted paragraph in the section titled: "Eating Patterns, Macronutrient Distribution, and Meal Planning" in the full version of the Standards of Medical Care in Diabetes (https://doi.org/10.2337/dc19-S005) has been updated to state the following:

      “Evidence suggests that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with diabetes. Therefore, macronutrient distribution should be based on an individualized assessment of current eating patterns, preferences, and metabolic goals. Consider personal preferences (e.g., tradition, culture, religion, health beliefs and goals, economics) as well as metabolic goals when working with individuals to determine the best eating pattern for them (35,51,52). It is important that each member of the health care team be knowledgeable about nutrition therapy principles for people with all types of diabetes and be supportive of their implementation. A variety of eating patterns are acceptable for the management of diabetes (51,54). Until the evidence surrounding comparative benefits of different eating patterns in specific individuals strengthens, health care providers should focus on the key factors that are common among the patterns: 1) emphasize nonstarchy vegetables, 2) minimize added sugars and refined grains, and 3) choose whole foods over highly processed foods to the extent possible (Evert 2019). Referral to an RD or registered dietitian nutritionist (RDN) is essential to assess the overall nutrition status of, and to work collaboratively with, the patient to create a personalized meal plan that considers the individual’s health status, skills, resources, food preferences, and health goals to coordinate and align with the overall treatment plan including physical activity and medication. The Mediterranean-style (55,56), low-carbohydrate (add 2 references) and plant-based (60,61) eating patterns are all examples of healthful eating patterns that have shown positive results in research, but individualized meal planning should focus on personal preferences, needs, and goals. Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia and may be applied in a variety of eating patterns that meet individual needs and preferences. For individuals with type 2 diabetes not meeting glycemic targets or where reducing glucose-lowering drugs is a priority, reducing overall carbohydrate intake with a low- or very low-carbohydrate eating pattern is a viable option. (Sainsbury 2018, van Zuuren 2018, Snorgaard 2017). As research studies on some low-carbohydrate eating plans generally indicate challenges with long-term sustainability, it is important to reassess and individualize meal plan guidance regularly for those interested in this approach. This eating pattern is not recommended at this time for women who are pregnant or lactating, people with or at risk for disordered eating, or people who have renal disease, and it should be used with caution in patients taking sodium–glucose cotransporter 2 (SGLT2) inhibitors due to the potential risk of ketoacidosis (65,66). There is inadequate research in type 1 diabetes to support one eating pattern over another at this time.”

      Added References:

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Sainsbury E, Kizirian NV, Partridge SR, et al. Effect of dietary carbohydrate restriction on glycemic control in adults with diabetes: a systematic review and meta-analysis. Diabetes Res Clin Pract 2018;139:239-252

      van Zuuren EJ, Fedorowicz Z, Kuijpers T, et al. Effects of low-carbohydrate compared with low-fat-diet interventions on metabolic control in people with type 2 diabetes: a systematic review including GRADE assessments. Am J Clin Nutr 2018;108:300-331

      Snorgaard O, Poulsen GM, Andersen HK, Astrup A. Systematic review and meta-analysis of dietary carbohydrate restriction in patients with type 2 diabetes. BMJ Open Diabetes Res Care 2017;5:e000354

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/uWUiyGH5Eem54GvhkvXnxQ/clinical.diabetesjournals.org/content/37/1/11

    2. Glucose-lowering medication in type 2 diabetes: overall approach. For appropriate context, see Figure 1. CV, cardiovascular; CVOTs, cardiovascular outcomes trials; DPP-4i, dipeptidyl peptidase 4 inhibitor; GLP-1 RA, GLP-1 receptor agonist; HbA1c, glycated hemoglobin; HF, heart failure; SGLT2i, SGLT2 inhibitor; SU, sulfonylurea; TZD, thiazolidinedione. Adapted from Davies MJ, D’Alessio DA, Fradkin J, et al. Diabetes Care 2018;41:2669–2701.

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, which showed a reduction of hospitalization for heart failure and a reduction in progression of CKD, footnote #3 within Figure 9.1 is revised to read:

      "Empagliflozin, canagliflozin and dapagliflzoin have shown reduction in HF and reduction in CKD progression in CVOTs"

      Reference:

      Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published March 27, 2019.

      Annotation approved by PPC March 13, 2019.

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/rMRMjlClEemsjTN6FY9fKw/clinical.diabetesjournals.org/content/37/1/11

    3. Drug-Specific and Patient Factors to Consider When Selecting Antihyperglycemic Treatment in Adults With Type 2 Diabetes

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, which showed a reduction of hospitalization for heart failure with dapagliflozin treatment versus placebo (HR: 0.73; 95% CI: 0.61 to 0.88), the portion of the figure highlighting benefit of SGLT-2 inhibitors for CHF is revised to read:

      "Benefit: empagliflozin†, canagliflozin, dapagliflozin"

      Reference:

      Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published March 27, 2019.

      Annotation approved by PPC March 13, 2019.

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/CpqqolClEemGSsOZLJaq8w/clinical.diabetesjournals.org/content/37/1/11

      Based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, which showed a reduction in renal events (composite of ≥40% decrease in eGFR to <60 ml per minute per 1.73m2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular cause) with dapagliflozin treatment versus placebo (HR: 0.76; 95% CI: 0.67 to 0.87), the portion of the figure highlighting benefit of SGLT-2 inhibitors for CHF is revised to read:

      "Benefit: empagliflozin, canagliflozin, dapagliflozin"

      Reference:

      Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019;380:347-357

      Annotation published March 27, 2019.

      Annotation approved by PPC March 13, 2019.

      Suggested citation: American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S90–S102. Retrieved from https://hyp.is/CpqqolClEemGSsOZLJaq8w/clinical.diabetesjournals.org/content/37/1/11

    1. Table 5.1 Medical nutrition therapy recommendations

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report," (http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014 recommendation 5.11 has been updated to the following:

      5.11 A variety of eating patterns are acceptable for the management of type 2 diabetes and prediabetes. Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia and may be applied in a variety of eating patterns that meet individual needs and preferences. For select adults with type 2 diabetes not meeting glycemic targets or where reducing glucose-lowering medications is a priority, reducing overall carbohydrate intake with low- or very low carbohydrate eating plans is a viable approach. B

      Added Reference:

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/Wve6FGH2Eemy_D-YBCn8Ww/care.diabetesjournals.org/content/42/Supplement_1/S46

    2. 5.11 A variety of eating patterns are acceptable for the management of type 2 diabetes and prediabetes.

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report," (http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014) recommendation 5.11 has been updated to the following:

      5.11 A variety of eating patterns are acceptable for the management of type 2 diabetes and prediabetes. Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia and may be applied in a variety of eating patterns that meet individual needs and preferences. For select adults with type 2 diabetes not meeting glycemic targets or where reducing glucose-lowering medications is a priority, reducing overall carbohydrate intake with low- or very low carbohydrate eating plans is a viable approach. B

      Added Reference:

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/Wve6FGH2Eemy_D-YBCn8Ww/care.diabetesjournals.org/content/42/Supplement_1/S46

    3. Individuals with type 1 or type 2 diabetes taking insulin at mealtime should be offered intensive and ongoing education on the need to couple insulin administration with carbohydrate intake. For people whose meal schedule or carbohydrate consumption is variable, regular counseling to help them understand the complex relationship between carbohydrate intake and insulin needs is important. In addition, education on using the insulin-to-carbohydrate ratios for meal planning can assist them with effectively modifying insulin dosing from meal to meal and improving glycemic control (51,82,93–96). Individuals who consume meals containing more protein and fat than usual may also need to make mealtime insulin dose adjustments to compensate for delayed postprandial glycemic excursions (97–99). For individuals on a fixed daily insulin schedule, meal planning should emphasize a relatively fixed carbohydrate consumption pattern with respect to both time and amount (35).

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report,"(http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014) the last highlighted paragraph in the section "Carbohydrates" is updated to state the following:

      “Individuals with type 1 or type 2 diabetes taking insulin at mealtime should be offered intensive and ongoing education on the need to couple insulin administration with carbohydrate intake. For people whose meal schedule or carbohydrate consumption is variable, regular counseling to help them understand the complex relationship between carbohydrate intake and insulin needs is important. In addition, education on using the insulin-to-carbohydrate ratios for meal planning can assist them with effectively modifying insulin dosing from meal to meal and improving glycemic control (51,82,93–96). Results from recent high-fat and/or high-protein mixed meals studies continue to support previous findings that glucose response to mixed meals high in protein and/or fat along with carbohydrate differ among individuals; therefore a cautious approach to increasing insulin doses for high-fat and/or high-protein mixed meals is recommended to address delayed hyperglycemia that may occur 3 h or more after eating (Evert 2019). Checking glucose 3 h after eating may help to determine if additional insulin adjustments are required (Bell 2016, Campbell 2016). Continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG) should guide decision-making for administration of additional insulin. For individuals on a fixed daily insulin schedule, meal planning should emphasize a relatively fixed carbohydrate consumption pattern with respect to both time and amount (35).”

      Added References:

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized mealtime insulin dosing for fat and protein in type 1 diabetes: application of a model-based approach to derive insulin doses for open-loop diabetes management. Diabetes Care 2016;39:1631-1634

      Campbell MD, Walker M, King D, et al. Carbohydrate counting at meal time followed by a small secondary postprandial bolus injection at 3 hours prevents late hyperglycemia, without hypoglycemia, after a high-carbohydrate, high-fat meal in type 1 diabetes. Diabetes Care 2016;39:e141-e142

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested Citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/rJH-smH1Eem4_gfccgHmrA/care.diabetesjournals.org/content/42/Supplement_1/S46

    4. Weight ManagementManagement and reduction of weight is important for people with type 1 diabetes, type 2 diabetes, or prediabetes who have overweight or obesity. Lifestyle intervention programs should be intensive and have frequent follow-up to achieve significant reductions in excess body weight and improve clinical indicators. There is strong and consistent evidence that modest persistent weight loss can delay the progression from prediabetes to type 2 diabetes (51,68,69) (see Section 3 “Prevention or Delay of Type 2 Diabetes”) and is beneficial to the management of type 2 diabetes (see Section 8 “Obesity Management for the Treatment of Type 2 Diabetes”).

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report," (http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014) the first highlighted paragraph in the section "Weight Management" is updated to state the following:

      “Management and reduction of weight is important for people with type 1 diabetes, type 2 diabetes, or prediabetes who have overweight or obesity. To support weight loss and improve A1C, CVD risk factors, and quality of life in adults with overweight/obesity and prediabetes or diabetes, MNT and DSMES services should include an individualized eating plan in a format that results in an energy deficit in combination with enhanced physical activity (Evert 2019). Lifestyle intervention programs should be intensive and have frequent follow-up to achieve significant reductions in excess body weight and improve clinical indicators. There is strong and consistent evidence that modest persistent weight loss can delay the progression from prediabetes to type 2 diabetes (51,68,69) (see Section 3 “Prevention or Delay of Type 2 Diabetes”) and is beneficial to the management of type 2 diabetes (see Section 8 “Obesity Management for the Treatment of Type 2 Diabetes”).”

      Added Reference:

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/wDnnZGH0EemOletoIP3F9Q/care.diabetesjournals.org/content/42/Supplement_1/S46

    5. Studies of reduced calorie interventions show reductions in A1C of 0.3% to 2.0% in adults with type 2 diabetes, as well as improvements in medication doses and quality of life (50,51). Sustaining weight loss can be challenging (70,71) but has long-term benefits; maintaining weight loss for 5 years is associated with sustained improvements in A1C and lipid levels (72). Weight loss can be attained with lifestyle programs that achieve a 500–750 kcal/day energy deficit or provide ∼1,200–1,500 kcal/day for women and 1,500–1,800 kcal/day for men, adjusted for the individual's baseline body weight. For many obese individuals with type 2 diabetes, weight loss of at least 5% is needed to produce beneficial outcomes in glycemic control, lipids, and blood pressure (70). It should be noted, however, that the clinical benefits of weight loss are progressive and more intensive weight loss goals (i.e., 15%) may be appropriate to maximize benefit depending on need, feasibility, and safety (73). MNT guidance from an RD/RDN with expertise in diabetes and weight management, throughout the course of a structured weight loss plan, is strongly recommended.

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report," (http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014) the second highlighted paragraph in the section "Weight Management" is updated to state the following:

      “In prediabetes, the weight loss goal is 7–10% for preventing progression to type 2 diabetes (Hamman 2006). In conjunction with lifestyle therapy, medication-assisted weight loss can be considered for people at risk for type 2 diabetes when needed to achieve and sustain 7–10% weight loss (Carlsson 2012, Booth 2014). People with prediabetes at a healthy weight should be considered for lifestyle intervention involving both aerobic and resistance exercise (Hamman 2006, Jeon 2007, Duncan 2003) and a healthy eating plan such as a Mediterranean-style eating pattern (75). For many overweight and obese individuals with type 2 diabetes, 5% weight loss is needed to achieve beneficial outcomes in glycemic control, lipids, and blood pressure (70). It should be noted, however, that the clinical benefits of weight loss are progressive, and more intensive weight loss goals (i.e., 15%) may be appropriate to maximize benefit depending on need, feasibility, and safety (73, Wing 2011). In select individuals with type 2 diabetes, an overall healthy eating plan that results in energy deficit in conjunction with weight loss medications and/or metabolic surgery should be considered to help achieve weight loss and maintenance goals, lower A1C, and reduce CVD risk (Sjöström 2014, Garvey 2014, Cefalu 2015). Overweight and obesity are also increasingly prevalent in people with type 1 diabetes and present clinical challenges regarding diabetes treatment and CVD risk factors (Prinz 2018, Lipman 2013). Sustaining weight loss can be challenging (70,71) but has long-term benefits; maintaining weight loss for 5 years is associated with sustained improvements in A1C and lipid levels (72). MNT guidance from an RD/RDN with expertise in diabetes and weight management, throughout the course of a structured weight loss plan, is strongly recommended. People with diabetes and prediabetes should be screened and evaluated during DSMES and MNT encounters for disordered eating, and nutrition therapy should accommodate these disorders (Evert 2019).”

      Added References:

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Hamman RF, Wing RR, Edelstein SL, et al. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care 2006;29:2102-2107

      Carlsson LMS, Peltonen M, Ahlin S, et al. Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. N Engl J Med 2012;367:695-704

      Booth H, Khan O, Prevost T, et al. Incidence of type 2 diabetes after bariatric surgery: population-based matched cohort study. Lancet Diabetes Endocrinol 2014;2:963-968

      Jeon CY, Lokken RP, Hu FB, van Dam RM. Physical activity of moderate intensity and risk of type 2 diabetes: a systematic review. Diabetes Care 2007;30:744-752

      Duncan GE, Perri MG, Theriaque DW, et al. Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care 2003;26:557-562

      Wing RR, Lang W, Wadden TA, et al.; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care 2011;34:1481-1486

      Sjöström L, Peltonen M, Jacobson P, et al. Association of bariatric surgery with long-term remission of type 2 diabetes and with microvascular and macrovascular complications. JAMA 2014;311:2297-2304

      Garvey WT, Ryan DH, Bohannon NJV, et al. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Diabetes Care 2014;37:3309-3316

      Cefalu WT, Leiter LA, de Bruin TWA, et al. Dapagliflozin’s effects on glycemia and cardiovascular risk factors in high-risk patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension. Diabetes Care 2015;38:1218-1227

      Prinz N, Schwandt A, Becker M, et al. Trajectories of body mass index from childhood to young adulthood among patients with type 1 diabetes – a longitudinal group-based modeling approach based on the DPV Registry. J Pediatr 2018;201:78-85.e4 Lipman TH, Levitt Katz LE, Ratcliffe SJ, et al. Increasing incidence of type 1 diabetes in youth: twenty years of the Philadelphia Pediatric Diabetes Registry. Diabetes Care 2013;36:1597-1603

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested Citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/HL6qpmH1EemjTPO-APKCkA/care.diabetesjournals.org/content/42/Supplement_1/S46

    6. Eating Patterns, Macronutrient Distribution, and Meal PlanningEvidence suggests that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with diabetes. Therefore, macronutrient distribution should be based on an individualized assessment of current eating patterns, preferences, and metabolic goals. Consider personal preferences (e.g., tradition, culture, religion, health beliefs and goals, economics) as well as metabolic goals when working with individuals to determine the best eating pattern for them (35,51,52). It is important that each member of the health care team be knowledgeable about nutrition therapy principles for people with all types of diabetes and be supportive of their implementation. Emphasis should be on healthful eating patterns containing nutrient-dense foods, with less focus on specific nutrients (53). A variety of eating patterns are acceptable for the management of diabetes (51,54), and a referral to an RD or registered dietitian nutritionist (RDN) is essential to assess the overall nutrition status of, and to work collaboratively with, the patient to create a personalized meal plan that considers the individual’s health status, skills, resources, food preferences, and health goals to coordinate and align with the overall treatment plan including physical activity and medication. The Mediterranean (55,56), Dietary Approaches to Stop Hypertension (DASH) (57–59), and plant-based (60,61) diets are all examples of healthful eating patterns that have shown positive results in research, but individualized meal planning should focus on personal preferences, needs, and goals. In addition, research indicates that low-carbohydrate eating plans may result in improved glycemia and have the potential to reduce antihyperglycemic medications for individuals with type 2 diabetes (62–64). As research studies on some low-carbohydrate eating plans generally indicate challenges with long-term sustainability, it is important to reassess and individualize meal plan guidance regularly for those interested in this approach. This meal plan is not recommended at this time for women who are pregnant or lactating, people with or at risk for disordered eating, or people who have renal disease, and it should be used with caution in patients taking sodium–glucose cotransporter 2 (SGLT2) inhibitors due to the potential risk of ketoacidosis (65,66). There is inadequate research in type 1 diabetes to support one eating plan over another at this time.

      Based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report," (http://care.diabetesjournals.org/lookup/doi/10.2337/dci19-0014) the highlighted paragraph in the section titled: "Eating Patterns, Macronutrient Distribution, and Meal Planning" is updated to state the following:

      “Evidence suggests that there is not an ideal percentage of calories from carbohydrate, protein, and fat for all people with diabetes. Therefore, macronutrient distribution should be based on an individualized assessment of current eating patterns, preferences, and metabolic goals. Consider personal preferences (e.g., tradition, culture, religion, health beliefs and goals, economics) as well as metabolic goals when working with individuals to determine the best eating pattern for them (35,51,52). It is important that each member of the health care team be knowledgeable about nutrition therapy principles for people with all types of diabetes and be supportive of their implementation. A variety of eating patterns are acceptable for the management of diabetes (51,54). Until the evidence surrounding comparative benefits of different eating patterns in specific individuals strengthens, health care providers should focus on the key factors that are common among the patterns: 1) emphasize nonstarchy vegetables, 2) minimize added sugars and refined grains, and 3) choose whole foods over highly processed foods to the extent possible (Evert 2019). Referral to an RD or registered dietitian nutritionist (RDN) is essential to assess the overall nutrition status of, and to work collaboratively with, the patient to create a personalized meal plan that considers the individual’s health status, skills, resources, food preferences, and health goals to coordinate and align with the overall treatment plan including physical activity and medication. The Mediterranean-style (55,56), low-carbohydrate (add 2 references) and plant-based (60,61) eating patterns are all examples of healthful eating patterns that have shown positive results in research, but individualized meal planning should focus on personal preferences, needs, and goals. Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia and may be applied in a variety of eating patterns that meet individual needs and preferences. For individuals with type 2 diabetes not meeting glycemic targets or where reducing glucose-lowering drugs is a priority, reducing overall carbohydrate intake with a low- or very low-carbohydrate eating pattern is a viable option. (Sainsbury 2018, van Zuuren 2018, Snorgaard 2017). As research studies on some low-carbohydrate eating plans generally indicate challenges with long-term sustainability, it is important to reassess and individualize meal plan guidance regularly for those interested in this approach. This eating pattern is not recommended at this time for women who are pregnant or lactating, people with or at risk for disordered eating, or people who have renal disease, and it should be used with caution in patients taking sodium–glucose cotransporter 2 (SGLT2) inhibitors due to the potential risk of ketoacidosis (65,66). There is inadequate research in type 1 diabetes to support one eating pattern over another at this time.”

      Added References

      Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731-754

      Sainsbury E, Kizirian NV, Partridge SR, et al. Effect of dietary carbohydrate restriction on glycemic control in adults with diabetes: a systematic review and meta-analysis. Diabetes Res Clin Pract 2018;139:239-252

      van Zuuren EJ, Fedorowicz Z, Kuijpers T, et al. Effects of low-carbohydrate compared with low-fat-diet interventions on metabolic control in people with type 2 diabetes: a systematic review including GRADE assessments. Am J Clin Nutr 2018;108:300-331

      Snorgaard O, Poulsen GM, Andersen HK, Astrup A. Systematic review and meta-analysis of dietary carbohydrate restriction in patients with type 2 diabetes. BMJ Open Diabetes Res Care 2017;5:e000354

      Annotation published April 18, 2019.

      Annotation approved by PPC April 16, 2019.

      Suggested citation: American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S46–S60. Retrieved from https://hyp.is/GxDNSGH0Eempk4MJj7kxnQ/care.diabetesjournals.org/content/42/Supplement_1/S46

    7. 5. Lifestyle Management: Standards of Medical Care in Diabetes—2019

      This article contains updated information as of April 18, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards.

  6. Mar 2019
    1. Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers

      This article contains updated information as of March 27, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards at https://doi.org/10.2337/dci17-0064

      Read about the methodology behind the living Standards at https://professional.diabetes.org/content-page/living-standards

    1. Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers

      This article contains updated information as of March 27, 2019.

      The ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards of Care.

      Read about the methodology behind the living Standards.

  7. Oct 2018
    1. Pharmacologic Therapy for Type 2 Diabetes

      ADA-EASD Consensus Report reflects current treatment recommendations as endorsed by the ADA and the PPC.

      On October 5, 2018, the consensus report “Management of Hyperglycemia in Type 2 Diabetes: ADA-EASD Consensus Report 2018” was published. The consensus report was developed by a writing group consisting of representatives from the ADA and EASD. The consensus report addresses approaches to glycemic management in adults with type 2 diabetes with the goal of reducing complications and maintaining quality of life in the context of comprehensive cardiovascular risk management and patient-centered care. The ADA Professional Practice Committee (PPC) was involved in the review and approval of the final consensus report. The consensus recommendations and approach to glycemic management in adults with type 2 diabetes presented within the report reflects the current view of the ADA. Please find a link to the consensus document here: http://dx.doi.org/10.2337/dci18-0033

      Reference:

      Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB: Management of hyperglycemia in type 2 diabetes, 2018: a consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care Oct 2018; DOI: 10.2337/dci18-0033

      Rationale/Reason for Change:

      Management of Hyperglycemia in Type 2 Diabetes: ADA-EASD Consensus Report 2018 reflects current treatment recommendations as endorsed by the ADA and the PPC.

      Annotation published: October 5, 2018. Annotation approved by PPC: September 20, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/1p2zesvFEeioRdNqCoou5A/clinical.diabetesjournals.org/content/36/1/14

    2. Standards of Medical Care in Diabetes—2018 Abridged for Primary Care Providers

      This article contains updated information as of October 5, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation.

      Read more about the living Standards of Care.

      Read about the methodoloy.

    1. PHARMACOLOGIC THERAPY FOR TYPE 2 DIABETES

      ADA-EASD Consensus Report reflects current treatment recommendations as endorsed by the ADA and the PPC.

      On October 5, 2018, the consensus report “Management of Hyperglycemia in Type 2 Diabetes: ADA-EASD Consensus Report 2018” was published. The consensus report was developed by a writing group consisting of representatives from the ADA and EASD. The consensus report addresses approaches to glycemic management in adults with type 2 diabetes with the goal of reducing complications and maintaining quality of life in the context of comprehensive cardiovascular risk management and patient-centered care. The ADA Professional Practice Committee (PPC) was involved in the review and approval of the final consensus report. The consensus recommendations and approach to glycemic management in adults with type 2 diabetes presented within the report reflects the current view of the ADA. Please find a link to the consensus document here: http://dx.doi.org/10.2337/dci18-0033

      Reference:

      Davies MJ, D’Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB: Management of hyperglycemia in type 2 diabetes, 2018: a consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care Oct 2018; DOI: 10.2337/dci18-0033

      Rationale/Reason for Change:

      Management of Hyperglycemia in Type 2 Diabetes: ADA-EASD Consensus Report 2018 reflects current treatment recommendations as endorsed by the ADA and the PPC.

      Annotation published: October 5, 2018. Annotation approved by PPC: September 20, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/JfeOQMinEeirdE8O1uE9wg/care.diabetesjournals.org/content/41/Supplement_1/S73

    2. 8. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of October 5, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation.

      Read more about the living Standards of Care.

      Read about the methodoloy.

  8. Aug 2018
    1. Insulin-treated patients with hypoglycemia unawareness or an episode of clinically significant hypoglycemia should be advised to raise their glycemic targets to strictly avoid hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. A

      This recommendation is offically updated to state the following:

      Insulin-treated patients with hypoglycemia unawareness or an episode of level 2 (<54 mg/dL [3.0 mmol/L]) hypoglycemia should be advised to raise their glycemic targets to strictly avoid hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. A

      Reason for Change: Alignment of terminology/definitions will minimize confusion for practitioners. To align hypoglycemia definitions between a consensus report (reference below) and the Standards of Care, hypoglycemia has been re-categorized into 3 levels as outlined in the annotation to table 6.3.

      References:

      Agiostratidou G, Anhalt H, Ball D, et al. Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care 2017;40:1622-1630.

      American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/wmtWGjwnEeiOWY_FhVG-zA/care.diabetesjournals.org/content/41/Supplement_1/S55.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested Citation: American Diabetes Association. Standards of Medical Care in Diabetes—2018 Abridged for Primary Care Providers [web annotation]. Clinical Diabetes 2018;36(1):14-37. Retrieved from https://hyp.is/GRjHQj2iEei1dkdhu5hlMw/clinical.diabetesjournals.org/content/36/1/14.

    2. Glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L), so it is available should it be needed. Caregivers, school personnel, or family members of these individuals should know where it is and when and how to administer it. Glucagon administration is not limited to health care professionals. E

      This recommendation is officially updated to state the following:

      Glucagon should be prescribed for all individuals at increased risk of level 2 hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L), so it is available should it be needed. Caregivers, school personnel, or family members of these individuals should know where it is and when and how to administer it. Glucagon administration is not limited to health care professionals. E

      Reason for Change: Alignment of terminology/definitions will minimize confusion for practitioners. To align hypoglycemia definitions between a consensus report (reference below) and the Standards of Care, hypoglycemia has been re-categorized into 3 levels as outlined in the annotation to table 6.3.

      References:

      Agiostratidou G, Anhalt H, Ball D, et al. Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care 2017;40:1622-1630.

      American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/wmtWGjwnEeiOWY_FhVG-zA/care.diabetesjournals.org/content/41/Supplement_1/S55.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested Citation: American Diabetes Association. Standards of Medical Care in Diabetes—2018 Abridged for Primary Care Providers [web annotation]. Clinical Diabetes 2018;36(1):14-37. Retrieved from https://hyp.is/bRFwXD2hEeidg9OXP8lExw/clinical.diabetesjournals.org/content/36/1/14.

    3. The hypoglycemia alert value in hospitalized patients is defined as blood glucose ≤70 mg/dL (3.9 mmol/L) and clinically significant hypoglycemia as glucose values <54 mg/dL (3.0 mmol/L).

      This section is officially updated to state the following:

      "Level 1 hypoglycemia in hospitalized patients is defined as a blood glucose <70 mg/dL (3.9 mmol/L) and level 2 hypoglycemia as glucose values <54 mg/dL (3.0 mmol/L)."

      Reason for Change: Alignment of terminology/definitions will minimize confusion for practitioners. To align hypoglycemia definitions between a consensus report (reference below) and the Standards of Care, hypoglycemia has been re-categorized into 3 levels as outlined described in the annotation to table 6.3.

      References:

      Agiostratidou G, Anhalt H, Ball D, et al. Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care 2017;40:1622-1630.

      American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/wmtWGjwnEeiOWY_FhVG-zA/care.diabetesjournals.org/content/41/Supplement_1/S55.

      Annotation published April 11, 2018. Annotation approved by PPC: March 10, 2018.

      Suggested Citation: American Diabetes Association. Standards of Medical Care in Diabetes—2018 Abridged for Primary Care Providers [web annotation]. Clinical Diabetes 2018;36(1):14-37. Retrieved from https://hyp.is/ZrydmD2iEeiE8GuxzoHaoA/clinical.diabetesjournals.org/content/36/1/14.

    1. 14. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of April 11, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards.

      Read about the [methodology] (https://professional.diabetes.org/content-page/living-standards) behind the living Standards.

    2. The hypoglycemia alert value in hospitalized patients is defined as blood glucose ≤70 mg/dL (3.9 mmol/L) (17) and clinically significant hypoglycemia as glucose values <54 mg/dL (3.0 mmol/L). Severe hypoglycemia is defined as that associated with severe cognitive impairment regardless of blood glucose level (17).

      For alignment with the annotation to table 6.3, this section of text is officially updated to state the following:

      "Level 1 hypoglycemia in hospitalized patients is defined as a measurable glucose concentration <70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L). Level 2 hypoglycemia (defined as a blood glucose concentration <54 mg/dL [3.0 mmol/L]) is the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. Lastly, level 3 hypoglycemia is defined as a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery."

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 14. Diabetes care in the hospital: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S144–S151. Retrieved from https://hyp.is/ah1vYjwrEeiRdH_dRhvglA/care.diabetesjournals.org/content/41/Supplement_1/S144.

    1. GLP-1 receptor agonists

      Semaglutide now included among GLP-1 receptor agonists

      In December 2017, the U.S. FDA approved the GLP-1 receptor agonist semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209637. Accessed January 1, 2018

      Rationale: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from [link to annotation].

    2. SGLT2 inhibitors

      Ertugliflozin now included among SGLT2 inhibitors

      In December 2017, the U.S. Food and Drug Administration approved the SGLT2 inhibitor ertugliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209803. Accessed 1 January 2018

      Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/1LVY-jwpEeiYsffMyzm1HQ/care.diabetesjournals.org/content/41/Supplement_1/S73.

    3. Table 8.2

      Table 8.2 to include semaglutide

      In December 2017, the U.S. FDA approved the GLP-1 receptor agonist semaglutide as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209637. Accessed January 1, 2018

      Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/D0tVED2WEeiK8ZvLIDyLZg/care.diabetesjournals.org/content/41/Supplement_1/S73.

    4. Table 8.2

      Table 8.2 to include ertugliflozin

      In December 2017, the U.S. Food and Drug Administration approved the SGLT2 inhibitor ertugliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

      Reference:

      U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=209803. Accessed 1 January 2018

      Rationale/Reason for Change: Approval of new treatments (medications or devices) has the potential to impact patient care.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 8. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S73–S85. Retrieved from https://hyp.is/8Qjypj2VEei_E2-Ft0MSjQ/care.diabetesjournals.org/content/41/Supplement_1/S73.

    1. 14. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of April 11, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards.

      Read about the [methodology] (https://professional.diabetes.org/content-page/living-standards) behind the living Standards.

    2. 8. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of April 11, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards.

      Read about the [methodology] (https://professional.diabetes.org/content-page/living-standards) behind the living Standards.

    3. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of April 11, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards.

      Read about the [methodology] (https://professional.diabetes.org/content-page/living-standards) behind the living Standards.

    4. 14. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of April 11, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards.

      Read about the [methodology] (https://professional.diabetes.org/content-page/living-standards) behind the living Standards.

    1. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2018

      This article contains updated information as of April 11, 2018.

      As of 2018, the ADA updates and revises the online version of the Standards of Care throughout the year, making necessary additions and annotations as new evidence and regulatory changes merit immediate incorporation. The annotated Standards of Medical Care are referred to as the "living" Standards.

      Read more about the living Standards.

      Read about the [methodology] (https://professional.diabetes.org/content-page/living-standards) behind the living Standards.

    2. Glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L), so it is available should it be needed. Caregivers, school personnel, or family members of these individuals should know where it is and when and how to administer it. Glucagon administration is not limited to health care professionals. E

      For alignment with the annotation to table 6.3, this recommendation is offically updated to state the following:

      Glucagon should be prescribed for all individuals at increased risk of level 2 hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L), so it is available should it be needed. Caregivers, school personnel, or family members of these individuals should know where it is and when and how to administer it. Glucagon administration is not limited to health care professionals. E

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/7fVa4jwnEeiJD0vde2XXyw/care.diabetesjournals.org/content/41/Supplement_1/S55.

    3. Insulin-treated patients with hypoglycemia unawareness or an episode of clinically significant hypoglycemia should be advised to raise their glycemic targets to strictly avoid hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. A

      For alignment with the annotation to table 6.3, this recommendation is offically updated to state the following:

      Insulin-treated patients with hypoglycemia unawareness or an episode of level 2 (<54 mg/dL [3.0 mmol/L]) hypoglycemia should be advised to raise their glycemic targets to strictly avoid hypoglycemia for at least several weeks in order to partially reverse hypoglycemia unawareness and reduce risk of future episodes. A

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/DIadcjwoEeiDyj_McVdDvg/care.diabetesjournals.org/content/41/Supplement_1/S55.

    4. Recommendations from the International Hypoglycemia Study Group regarding the classification of hypoglycemia in clinical trials are outlined in Table 6.3 (75). Of note, this classification scheme considers a blood glucose <54 mg/dL (3.0 mmol/L) detected by SMBG, CGM (for at least 20 min), or laboratory measurement of plasma glucose as sufficiently low to indicate clinically significant hypoglycemia that should be included in reports of clinical trials of glucose-lowering drugs for the treatment of diabetes (75). However, a hypoglycemia alert value of ≤70 mg/dL (3.9 mmol/L) can be important for therapeutic dose adjustment of glucose-lowering drugs in clinical care and is often related to symptomatic hypoglycemia. Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person for recovery

      For alignment with the annotation to table 6.3, this section of text is officially updated to state the following:

      "Recommendations regarding the classification of hypoglycemia are outlined in Table 6.3. Level 1 hypoglycemia is defined as a measurable glucose concentration <70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L). A blood glucose concentration of 70 mg/dL has been recognized as a threshold for neuroendocrine responses to falling glucose in people without diabetes. Because many people with diabetes demonstrate impaired counterregulatory responses to hypoglycemia and/or experience hypoglycemia unawareness, a measured glucose level <70 mg/dL (3.9 mmol/L) is considered clinically important, independent of the severity of acute hypoglycemic symptoms. Level 2 hypoglycemia (defined as a blood glucose concentration <54 mg/dL [3.0 mmol/L]) is the threshold at which neuroglycopenic symptoms begin to occur, and requires immediate action to resolve the hypoglycemic event. Lastly, level 3 hypoglycemia is defined as a severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery."

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/wZBZiDwoEeihcafMFp0hhw/care.diabetesjournals.org/content/41/Supplement_1/S55.

    5. Table 6.3

      Table 6.3 is officially updated to align with a recently published Consensus Report: "Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. The consensus report categorized hypoglycemia into 3 levels as outlined in the following table:

      Reference:

      Agiostratidou G, Anhalt H, Ball D, et al. Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care 2017;40:1622-1630

      Rationale/reason for change:

      To align hypoglycemia definitions between the consensus report and the Standards of Care. Alignment of terminology/definitions will minimize confusion for practitioners.

      Annotation published April 11, 2018.

      Annotation approved by PPC: March 10, 2018.

      Suggested citation: American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2018 [web annotation]. Diabetes Care 2018;41(Suppl. 1):S55–S64. Retrieved from https://hyp.is/wmtWGjwnEeiOWY_FhVG-zA/care.diabetesjournals.org/content/41/Supplement_1/S55.