The Living Standards of Medical Care in Diabetes

Updates to the Standards of Medical Care in Diabetes

2019 Living Standards Updates
(incorporated into the 2020 Standards of Care):

July 31, 2019 Updates
(Liraglutide labeling change, Tamborlane et al., REWIND, Battelino et al.)

June 3, 2019 Updates
(CREDENCE and CANVAS Trials)

April 18, 2019 Updates
(Nutrition Therapy Consensus Statement)

March 27, 2019 Updates
(DECLARE-TIMI 58 and REDUCE-IT)

2018 Updates (2018 updates incorporated into the 2019 Standards of Care)

The American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes (Standards of Care) provide the latest in comprehensive, evidence-based recommendations for the diagnosis and treatment of children and adults with type 1, type 2 or gestational diabetes; strategies to prevent or delay type 2 diabetes; and therapeutic approaches that reduce complications and positively affect health outcomes. The Standards of Care is a “living” document where notable updates are incorporated as determined appropriate and voted on by the Professional Practice Committee (PPC). Updates are made in response to important events such as approval of new treatments (medications or devices) with the potential to impact patient care, publication of new findings that support a change to a recommendation and/or evidence level of a recommendation, or publication of a consensus document endorsed by ADA that necessitates an update of the Standards to align content of the documents. The updating process allows the online version (and downloadable PDF) to be updated and revised throughout the year by adding annotations to the Standards of Care published in Diabetes Care and the abridged Standards of Care publishing in Clinical Diabetes. For each “living” Standards update, ADA notifies providers and stakeholders through various communication channels (emails, websites, social medical, etc.) and revises the Standards of

Care slide deck, Standards of Care app, professional education programs, and selected other materials to be consistent with living Standards of Care updates.

For information on viewing Living Standards of Care annotations, see Viewing Annotations below.

July 31, 2019

The ADA issued important updates to the 2019 Standards of Care today, focusing on new metrics for continuous glucose monitoring (CGM) utilization and new medication options and recommendations for youth and adults with type 2 diabetes. The updates were informed by newly published research and crafted and approved by the ADA’s Professional Practice Committee, which is responsible for producing the annual Standards of Care. Updates to Section 10, Cardiovascular Disease and Risk Management, have also been reviewed and approved by the American College of Cardiology, who endorse this section.

Section 13. Children and Adolescents

1. 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:

UPDATE: "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"

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.

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 (page S157, 2019 Standards of Care):

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

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.

3. 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):

UPDATE: "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. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123.

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]

Annotations published: July 31, 2019

Annotations approved by PPC: July 26, 2019

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Section 9. Pharmacologic Approaches to Glycemic Treatment

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

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

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.

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

UPDATE: “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.”

3. The section “Cardiovascular Outcomes Trials” (2019 Standards of Care page S98) was revised to include results from REWIND:

UPDATE: 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]

Annotations published: July 31, 2019

Annotations approved by PPC: July 26, 2019

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Section 10. Cardiovascular Disease and Risk Management

1. 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:

UPDATE: 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).

2. Table 10.4 (2019 Standards of Care pages S117-S118) has been amended to include data from REWIND.

UPDATE: The table amendment is available at https://care.diabetesjournals.org/content/table-104-amendment

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 Jun 8. Doi:10.2337/dci19-0028. [Epub ahead of print]

Annotations published: July 31, 2019

Annotations approved by PPC: July 26, 2019

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Section 6. Glycemic Targets

The “Glucose Assessment” subsection in Section 6. Glycemic Targets has been updated to note metrics recommended by the International Consensus on Time in Range (2019 Standards of Care page S62) as shown below:

UPDATE: 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, 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.) 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

Suggested citation: American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123.

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

Suggested citation: American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123.
UPDATE: NEW Figure. Ambulatory Glucose Profile (reprinted from Battelino et al.), available at https://care.diabetesjournals.org/content/diacare/42/8/1593/F2.large.jpg

Suggested citation: American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S103–S123.

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 Jun 8. Doi:10.2337/dci19-0028. [Epub ahead of print]

Annotations published: July 31, 2019

Annotations approved by PPC: July 26, 2019

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Section 7. Diabetes Technology

The third paragraph of the sub-section ”Continuous Glucose Monitors” in Section 7. Diabetes Technology has been updated to incorporate information from the International Consensus on Time in Range (2019 Standards of Care pages S74-S75), including the addition of a new Table and a Figure of the Ambulatory Glucose Profile (AGP) in section 6. Glycemic Targets:

UPDATE: "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)."

Annotation published: July 31, 2019

Annotation approved by PPC: July 26, 2019

Suggested citation: American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes—2019 [web annotation]. Diabetes Care 2019;42(Suppl. 1):S71–S80.

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June 3, 2019

Today, we have issued important updates to the 2019 Standards of Care focused on improving cardiovascular and renal health in people with type 2 diabetes. Section 10, Cardiovascular Disease and Risk Management and Section 11, Microvascular Complications and Foot Care were updated based on findings from the Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (CREDENCE) trial, which was published on April 14, 2019, in the New England Journal of Medicine (https://doi.org/10.1056/NEJMoa1811744). The CREDENCE trial assessed the impact of canagliflozin therapy on cardiorenal outcomes in patients with diabetes-related chronic kidney disease. The updates are as follows.

Section 10. Cardiovascular Disease and Risk Management

The third paragraph of the subsection “Antihyperglycemic Therapies and Cardiovascular Outcomes” is edited and lengthened to incorporate findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, as follows:

UPDATE: "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

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The fourth paragraph of the subsection “Antihyperglycemic Therapies and Heart Failure” is edited to incorporate findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial.

UPDATE: "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 5,000 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.

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Section 11. Microvascular Complications and Foot Care

Recommendations have been updated based on findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, as follows:

UPDATE: 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
UPDATE: 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
UPDATE: 11.8 Based on findings from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, recommendation 11.8 in Section 11. Microvascular Complications and Foot Care has been removed and 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.

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:

UPDATE: "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/1.73m2, 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/1.73m2 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."

Annotation published: June 3, 2019.

Annotation approved by PPC: May 26, 2019.

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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:

UPDATE: "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.

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April 18, 2019

In 2018 ADA issued a nationwide call for experts to review the latest research on nutrition therapy for diabetes. The resulting writing group prepared a nutrition Consensus Report intended to update and replace the 2014 ADA nutrition Position Statement. The Consensus Report panel performed a comprehensive review of more than 600 key nutrition manuscripts published from 2014 through 2018. The resulting recommendations focus on key areas of nutrition management and guidelines to achieve optimal diabetes management, reduce complications, and improve quality of life for adults with type 1 or type 2 diabetes or prediabetes. The new nutrition consensus report is published online ahead of print and in the May issue of Diabetes Care (available April 22, 2019) in a special section titled “The Continuing Evolution of Nutritional Therapy for Diabetes.” Recommendations from this latest Consensus Report are included as updates to the Standards of Care. The April 18 Living Standards of Care updates:

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

Section 5 is updated based on information provided in the ADA document titled: "Nutrition Therapy for Adults with Diabetes or Prediabetes: A Consensus Report" per below.

UPDATE: 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

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UPDATE: 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

UPDATE: 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

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UPDATE: Table 5.1, Eating patterns and macronutrient distribution, recommendation 5.11 is 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”

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

UPDATE: The last highlighted paragraph in the section "Carbohydrates" has been changed 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).”

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

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March 27, 2019

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality for individuals with diabetes, and heart disease is the cause of one in four deaths in the U.S. Diabetes is the leading cause of chronic kidney disease, and approximately one out of four adults with diabetes has kidney disease. Recently published research indicated an urgent need to update the 2019 Standards of Care to ensure optimal treatment recommendations for people with cardiovascular disease and diabetes, and for those with chronic kidney disease and diabetes. The March 27 Living Standards of Care updates:

Section 10 is updated based on the outcome of Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), which determined the addition of icosapent ethyl to statin therapy for patients with high triglyceride levels reduced cardiovascular events. The Standards of Care now include a recommendation that icosapent ethyl be considered for patients with diabetes and atherosclerotic cardiovascular disease (ASCVD) or other cardiac risk factors on a statin with controlled LDL-C, but with elevated triglycerides (135-499) to reduce cardiovascular risk.
Sections 9, 10, and 11 are revised based on findings from The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial, in which dapagliflozin treatment showed a reduction of hospitalization for heart failure and a reduction in progression of chronic kidney disease (CKD).
Based on a revision to the prescribing information for dapagliflozin, for patients with diabetes and CKD, the approved use per estimated glomerular filtration rate (eGFR)
is revised from ≥60 mL/min/1.73 m2 to ≥45 mL/min/1.73 m2 in Section 11 of the Standards of Care.

The following 2018 updates were incorporated into the 2019 Standards of Care:

October 5, 2018

8. Pharmacologic Approaches to Glycemic Treatment

April 11, 2018

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The Living Standards of Medical Care in Diabetes

Updates to the Standards of Medical Care in Diabetes

July 31, 2019

Section 13. Children and Adolescents

Section 9. Pharmacologic Approaches to Glycemic Treatment

Section 10. Cardiovascular Disease and Risk Management

Section 6. Glycemic Targets

Section 7. Diabetes Technology

June 3, 2019

Section 10. Cardiovascular Disease and Risk Management

Section 11. Microvascular Complications and Foot Care

April 18, 2019

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

March 27, 2019

The following 2018 updates were incorporated into the 2019 Standards of Care:

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