Standards of Diabetes 2019 Medical Care in Diabetes 2019 - - PDF document

6/13/2019 1 Practical Application of the Updated American Diabetes Association (ADA) Standards of Medical Care in Diabetes – 2019

Presented by Ron Scott, R.Ph, Ph.C. 06/22/2019

Standards of Medical Care in Diabetes – 2019 Background

• Meeting in Berlin, Oct 2018 (Input since June)
• Simultaneously published in Diabetes Care and

Diabetologia

• Update to prior position statements in 2012 and

2015

• 479 (English) papers evaluated (pub since 2014)
• Incorporated into ADA Standards of Practice
• Central Theme: Decision Cycle for DM management

Outline

• Recent clinical trials that lay the foundation

for new recommendations

• Decision cycle for DM management
• Consensus recommendations from ADA/EASD
• Graphics/Algorithms for medication choices
• Emerging technologies, key knowledge gaps,

new and enduring questions

• Discussion

Key Takeaways

• For weight: Weight loss, lifestyle, medication, and

surgical intervention are all recommended

• For clinical CVD (Cardiovascular disease): SGLT-2 or

GLP-1 with proven CV benefit are recommended

• For CKD (Chronic Kidney Disease) or clinical HF (Heart

Failure) (esp w/ASCVD (Atherosclerotic CVD)): SGLT- 2 with proven benefit is recommended

• GLP-1 is generally recommended as the first

injectable medication

• Assess CV status first

Rationale

• Summarize large body of recent evidence
• ASCVD is the leading cause of death with DM2
• Diabetes self-management education and support

(DSMES) is fundamental to DM2 care

• Comprehensive implementation of evidence-based

interventions has been key to significant reduction of ASCVD events and mortality over past few decades

• ASCVD, HF, CKD affect 15-25% of DM patients

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Care Delivery Systems.

• 33-49% of patients still do not meet targets for

A1C, blood pressure, or lipids

• Only14% of patients meet targets for all A1C, BP,

lipids, and nonsmoking status

• Progress in CVD risk factor control is slowing
• System-level improvements are needed

Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S7-S12

Classification.

Diabetes can be classified into the following general categories:

• 1. Type 1 diabetes (due to autoimmune ß-cell destruction, usually

leading to absolute insulin deficiency)

• 2. Type 2 diabetes (due to a progressive loss of ß-cell insulin

secretion frequently on the background of insulin resistance)

• 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the

second or third trimester of pregnancy that was not clearly overt diabetes prior to gestation)

• 4. Specific types of diabetes due to other causes, e.g., monogenic

diabetes syndromes (such as neonatal diabetes and maturity-

• nset diabetes of the young [MODY]), diseases of the exocrine

pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as with glucocorticoid use, in the treatment of HIV/AIDS, or after organ transplantation)

Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S13-S28

Definition of ASCVD and MACE

• ASCVD is defined somewhat differently across trials
• All of the outcomes trials discussed today enrolled

individuals with established CVD (e.g. myocardial infarction [MI], stroke, any revascularization procedure).

• They variably included related conditions like TIA,

unstable angina, amputation, CHF, >50% stenosis of any artery, coronary artery disease, CKD

• Major adverse cardiac events [MACE]: Cardiovascular

death, non-fatal MI and non-fatal stroke

Recent GLP-1 Studies of Note

LEADER trial

• Liraglutide, studied in the Liraglutide Effect and Action in

Diabetes: Evaluation of Cardiovascular Outcomes Results (LEADER) trial (n = 9340)

• ARR of 1.9% with an HR of 0.87 (p = 0.01 for superiority)

for primary outcome of MACE compared with placebo

• ver 3.8 years.
• Each component of the composite contributed to the
• benefit. HR for cardiovascular death was 0.78 (p = 0.007;

ARR 1.7%). HR for all-cause mortality was 0.85 (p = 0.02; ARR 1.4%).

Recent GLP-1 Studies of Note SUSTAIN 6 trial

• Semaglutide, studied in the Trial to Evaluate

Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diabetes (SUSTAIN 6) (n = 3297)

• Compared with placebo demonstrated an ARR of

2.3% with HR 0.74 for MACE (p = 0.02 for superiority)

• ver 2.1 years
• Reduction in events appeared to be driven by the

rate of stroke, rather than CVD death

Recent Studies of Note EXSCEL trial

• Exenatide, studied in the Exenatide Study of

Cardiovascular Event Lowering (EXSCEL) trial (n=14,752)

• Compared exenatide ER with placebo over 3.2 years.

Exenatide was safe (non-inferior).

• HR for MACE in the entire trial was 0.91 (p = 0.06), not

demonstrating statistical superiority. ARR was 0.8%.

• All-cause death was lower in the exenatide arm (ARR 1%,

HR 0.86, but also not statistically significant.

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Recent GLP-1 Studies of Note

• Lixisenatide, a short-acting GLP-1, did not demonstrate

CVD benefit or harm in a trial of patients recruited within 180 days of an acute coronary syndrome and followed for 25 months (ELIXA) (n=6068) NEJM

• Taken together, it appears that among patients with

established CVD, some GLP-1 receptor agonists may provide cardiovascular benefit, with the evidence of benefit strongest for liraglutide, favorable for semaglutide, and less certain for exenatide. There is no evidence of cardiovascular benefit with lixisenatide.

Recent SGLT-2 Studies of Note EMPA-REG OUTCOME trial

• Empagliflozin, studied in the Empagliflozin Cardiovascular

Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial (n=7020) compared with placebo in patients with type 2 diabetes and CVD. Median follow-up 3.1 years.

• ARR was 1.6% and the HR was 0.86 (p = 0.04 for

superiority) for primary composite endpoint of MACE.

• The ARR was 2.2% and the HR was 0.62 (p < 0.001) for

cardiovascular death.

• The ARR was 2.6% and the HR was 0.68 (p < 0.001) for

death from any cause

Recent SGLT-2 Studies of Note

CANVAS and CANVAS-Renal

• Canagliflozin, studied in the Canagliflozin Cardiovascular Assessment

Study (CANVAS) Program (comprised of two similar trials, CANVAS and CANVAS-Renal); (n = 10,142) vs. placebo in participants with type 2 diabetes, 66% of whom had a history of CVD.

• Combined analysis of the two trials: Primary composite endpoint of

MACE was reduced with canagliflozin (26.9 vs 31.5) per patient-year vs placebo; HR 0.86 (p = 0.02) for superiority in the pooled analysis, with consistent findings in the component studies.

• There was a trend towards benefit for cardiovascular death, but the

difference from placebo was not statistically significant in the CANVAS Program.

• Participants were followed for a median of 3.6 years

Recent Studies of Note

Secondary Endpoint (HF)

• In the EMPA-REG OUTCOME and CANVAS CVOT studies testing SGLT2 inhibitors,

which enrolled participants with ASCVD, >85% of participants did not have symptomatic HF at baseline. Yet, in both trials there was a clinically and statistically significant reduction in hospitalization for HF for the SGLT2 inhibitor as compared with placebo

• In the GLP-1 receptor agonist studies LEADER, SUSTAIN 6 and EXSCEL, there was no

significant effect on hospitalization for HF with HR 0.86 (95% CI 0.71, 1.06), 1.11 (95% CI 0.77, 1.61) and 0.94 (95% CI 0.78, 1.13), respectively.

• Two short-term studies of liraglutide in patients with reduced ejection fraction

suggested a lack of benefit in this setting

Recent DPP-4 Studies of Note

• Among recent cardiovascular safety outcomes trials testing DPP-4 inhibitors,

the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) study evaluating saxagliptin demonstrated a significant increased risk of HF, with 3.5% risk of hospitalization for HF vs 2.8% for placebo (HR 1.27; p = 0.007).

• Subsequently, the Examination of Cardiovascular Outcomes with Alogliptin

versus Standard of Care (EXAMINE) study of alogliptin there was no statistically significant difference in HF hospitalization (3.9% vs 3.3% with placebo)

• In the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), the

rate of hospitalization for HF was 3.1% in both sitagliptin and placebo treated patients

Summary: Recent Studies of Note

• For the SGLT2 inhibitors studied to date, it appears that among patients with

established CVD, there is likely cardiovascular benefit, with the evidence of benefit modestly stronger for empagliflozin than canagliflozin.

• In GLP-1 and SGLT-2 subgroup analyses of trials, lower risk individuals have not

been observed to have an ASCVD benefit. This may be due to the short time frame

• f the studies and the low event rate in those without ASCVD.
• Overall, CVOTs of dipeptidyl peptidase-4 (DPP-4) inhibitors have demonstrated

safety, i.e. non-inferiority relative to placebo, for the primary MACE endpoint, but not cardiovascular benefit, but possibly increasing HF risk.

• There are no clinical trial data that support prescribing an SGLT2 inhibitor or GLP-1

receptor agonist with the intent of reducing cardiovascular risk in patients with an HbA1c <7%.

• Limited data suggest that there is no heterogeneity in the cardiovascular benefits
• f SGLT2 inhibitors or GLP-1 receptor agonists as a function of background glucose-

lowering therapy.

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Decision Cycle for Patient-Centered Glycemic Management in Type 2 Diabetes

Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S34-S45

Consensus Recommendation

Providers and health care systems should prioritize the delivery of patient-centered care

Providing patient-centered care that acknowledges multimorbidity, and is respectful of and responsive to individual patient preferences and barriers, including the differential costs of therapies, is essential to effective diabetes management Noted context: Cognitive impairment, limited literacy, distinct cultural beliefs, and individual fears or health concerns Case

Consensus Recommendation

All people with type 2 diabetes should be offered access to ongoing DSMES programs

While DSMES should be available on an ongoing basis, critical junctures when DSMES should occur include at diagnosis, annually, when complications arise, and during transitions in life and care The best outcomes are achieved in those programs with a theory- based and structured curriculum and with contact time of over 10

• hours. While online programs may reinforce learning, there is little

evidence they are effective when used alone

Case

Consensus Recommendation

Facilitating medication adherence should be specifically considered when selecting glucose-lowering medications

Suboptimal adherence, including poor persistence, to therapy affects almost half of people with diabetes Ultimately, patient preference is a major factor driving the choice of

• medication. Patient preferences regarding route of administration, injection

devices, side effects, or cost may prevent their use by some individuals Case

Adherence cont’d

Therapeutic inertia, sometimes referred to as clinical inertia, refers to failure to intensify therapy when treatment targets are not met. Multidisciplinary teams that include nurse practitioners or pharmacists may help reduce therapeutic inertia. A fragmented health care system may contribute to therapeutic inertia and impair delivery of patient centered care. A coordinated care model includes self-management support, decision support, delivery system design, clinical information systems, and community resources and policies. Case

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Glycemic Targets: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S61-S70

Consensus Recommendation

Metformin is the preferred initial glucose- lowering medication for most people with type 2 diabetes.

Recommendation is based on the efficacy, safety, tolerability, low cost, and extensive clinical experience with this medication A substudy of UKPDS (n=342) showed benefits of initial treatment with metformin on clinical outcomes related to diabetes, with less hypoglycemia and weight gain than with insulin or sulfonylureas

Case

Consensus Recommendation

The stepwise addition of glucose lowering medication is generally preferred to initial combination therapy.

In most patients, DM2 is a progressive disease, with monotherapy achieving a glycemic target typically limited to several years. Stepwise therapy is supported by clinical trials Although there is some support for initial combination therapy due to greater initial reduction of HbA1c than by metformin alone, there is little evidence that this approach is superior to sequential addition of medications

Stepwise cont’d

However, since the absolute effectiveness of most oral medications rarely exceeds a 1% reduction in HbA1c, initial combination therapy may be considered inpatients presenting with HbA1c levels more than 1.5% above their target Fixed-dose formulations can improve medication adherence when combination therapy is used Potential benefits of combination therapy need to be weighed against the exposure of patients to multiple medications and potential side effects, increased cost, and, in the case of fixed combination medications, less flexibility in dosing.

Case

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Consensus Recommendation

The selection of medication added to metformin is based on patient preference and clinical characteristics. Important clinical characteristics include the presence

• f established ASCVD and other comorbidities such as

HF or CKD; the risk for specific adverse medication effects, particularly hypoglycemia and weight gain; as well as safety, tolerability, and cost

Consensus Recommendation

Among patients with type 2 diabetes who have established ASCVD, SGLT2 inhibitors or GLP-1 receptor agonists with proven cardiovascular benefit are recommended as part of glycemic management

Case

Consensus Recommendation

Among patients with ASCVD in whom HF coexists or is

• f special concern, SGLT2 inhibitors are recommended

Case

Consensus Recommendation

For patients with type 2 diabetes and CKD, with or without CVD, consider the use of an SGLT2 inhibitor shown to reduce CKD progression or, if contraindicated

• r not preferred, a GLP-1 receptor agonist with proven

CVD benefit

Case

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Consensus Recommendation

Intensification of treatment beyond dual therapy to maintain glycemic targets requires consideration

• f the impact of medication side effects on

comorbidities, as well as the burden of treatment and cost.

The lack of a substantial response to one or more noninsulin therapies should raise the issue of adherence and, in those with weight loss, the possibility that the patient has autoimmune (type 1) or pancreatogenic diabetes.

Case

Consensus Recommendation

Access, treatment cost and insurance coverage should all be considered when selecting glucose-lowering medications.

Sulfonylureas and human insulin remain effective options

Case

Oral and Injectable Together Consensus Recommendation

In patients who need the greater glucose-lowering effect of an injectable medication, GLP-1 receptor agonists are the preferred choice to insulin. For patients with extreme and symptomatic hyperglycemia, insulin is recommended

There is currently no evidence that any single medication or combination has durable effects and, for many patients, injectable medications become necessary within 5–10 years of diabetes diagnosis.

Case

Consensus Recommendation

Patients who are unable to maintain glycemic targets

• n basal insulin in combination with oral medications

can have treatment intensified with GLP-1 receptor agonists, SGLT2 inhibitors, or prandial insulin

It has become common practice to approach insulin use in people with type 2 diabetes by following the established paradigms developed for those with type 1 diabetes. While this is reasonable for people with type 2 diabetes who are lean, insulinopenic, and sensitive to exogenous insulin, it ignores the substantial differences in pathophysiology between most people with type 2 diabetes and type 1 diabetes

Case

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Treatment Intensification cont’d

Most people with type 2 diabetes are obese and insulin resistant, requiring much larger doses of insulin and experiencing lower rates of hypoglycemia than those with type 1 diabetes. In patients with type 2 diabetes, weight gain is a particularly problematic side effect of insulin use In a meta-analysis that studied the combination of either SGLT2 inhibitors or DPP-4 inhibitors with insulin, the SGLT2 inhibitor–insulin combination was associated with a greater reduction in HbA1c, an advantage in terms of body weight and no increase in the rates of hypoglycemia

Case

Treatment Intensification cont’d

Most data come from studies in which a GLP-1 receptor agonist is added to basal insulin. There is evidence that insulin added to a GLP-1 receptor agonist can also effectively lower HbA1c Fixed-ratio combinations of insulin and GLP-1 receptor agonists are available and can decrease the number of injections compared with administering the medications separately A modestly greater reduction in HbA1c is seen with basal-prandial regimens compared with biphasic insulin regimens, but at the expense of greater weight gain. While still commonly used, we do not generally advocate premixed insulin regimens, particularly those administered three times daily, for routine use when intensifying insulin regimens. Continuous insulin infusion using insulin pumps may have a role in a small minority of people with type 2 diabetes

Case

Consensus Recommendation

An individualized program of MNT should be offered to all patients

The goal of MNT is to manage blood glucose and cardiovascular risk factors to reduce risk for diabetes-related complications while preserving the pleasure of eating Basic dimensions: Dietary quality and energy restriction There is no single ratio of carbohydrate, proteins, and fat intake that is

• ptimal for every person with type 2 diabetes

Accommodate patient preference and metabolic needs, with the goal of identifying healthy dietary habits that are feasible and sustainable.

MNT Cont’d

Three trials of a Mediterranean eating pattern reported modest weight loss and improved glycemic control A meta-analysis of RCTs in patients with type 2 diabetes showed that the Mediterranean eating pattern reduced HbA1c more than control diets Low-carbohydrate, low glycemic index, and high-protein diets, and the Dietary Approaches to Stop Hypertension (DASH) diet all improve glycemic control, but the effect of the Mediterranean eating pattern appears to be the greatest Low-carbohydrate diets produce substantial reductions in HbA1c at 3 months, with diminishing effects at 12 and 24 months No benefit of moderate carbohydrate restriction was observed Vegetarian eating patterns have been shown to lower HbA1c, but not fasting glucose Case

Consensus Recommendation

All overweight and obese patients with diabetes should be advised of the health benefits of weight loss and encouraged to engage in a program of intensive lifestyle management, which may include food substitution

The most effective nonsurgical strategies for weight reduction involve food substitution and intensive, sustained counseling

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Selected Studies:

The Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 overweight or obese patients with type 2 diabetes to intensive energy restriction and increased physical activity compared with standard diabetes education. After 9.6 years, weight loss was 6.0% vs. 3.5% at study end; HbA1c also fell in the intervention group despite less use of glucose-lowering

• medications. Cardiovascular event rates were not reduced, but there were numerous other

benefits. DiRECT Trial (Lead author Lean) Meal replacement formula diet for 3–5 months followed by gradual reintroduction of food and intensive counseling resulted in 9-kg placebo-adjusted weight loss at 1 year and high rates of diabetes remission (46% vs. 4%) compared with best usual

• practice. (n=306)

In a 12-month trial, 563 adults with DM2 randomized to Weight Watchers compared with standard care had a 2.1% net weight loss (24.0% vs. 21.9%), a net absolute improvement in HbA1c (0.48%) and a greater reduction in use of glucose lowering medications. Similar programs have resulted in a net 3-kg weight loss over 12–18 months

Consensus Recommendation

Increasing physical activity improves glycemic control and should be encouraged in all people with type 2 diabetes.

Aerobic exercise, resistance training, and the combination of the two are effective in reducing HbA1c by about 0.6% Evidence suggests that aerobic exercise and the combination of aerobic exercise and resistance training may be more effective than resistance training alone, but this remains controversial A wide range of physical activity, including leisure time activities (e.g., walking, swimming, gardening, jogging, tai chi, and yoga) can significantly reduce HbA1c Combination of weight reduction and physical exercise improves hyperglycemia and reduces cardiovascular risk factors more than either alone

Consensus Recommendation

Metabolic surgery is a recommended treatment

• ption for adults with type 2 diabetes and 1) a

BMI >/=40 (37.5 Asians) or 2) a BMI of 35.0–39.9 (32.5–37.4) who do not achieve durable weight loss and improvement in comorbidities with reasonable nonsurgical methods. Overweight/Obese Treatment Options.

Obesity Management for the Treatment of Type 2 Diabetes: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S81-S89

Body Mass Index (BMI) Category (kg/m2)

Treatment 25.0-26.9 (or 23.0- 26.9*) 27.0- 29.9 30.0-34.9 (or 27.5- 32.4*) 35.0-39.9 (or 32.5- 37.4*) ≥40 (or ≥37.5*) Diet, physical activity & behavioral therapy

┼ ┼ ┼ ┼ ┼

Pharmacothera py

┼ ┼ ┼ ┼

Metabolic surgery

┼ ┼ ┼

* Cutoff points for Asian-American individuals. ┼ Treatment may be indicated for selected, motivated patients.

Pharmacologic Interventions.

3.5 Metformin therapy for prevention of type 2 diabetes should be considered in those with prediabetes, especially for those with BMI ≥35 kg/m2, those aged <60 years, and women with prior gestational diabetes mellitus. A 3.6 Long-term use of metformin may be associated with biochemical vitamin B12 deficiency, and periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy. B

Prevention or Delay of Type 2 Diabetes: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S29-S33

Pharmacologic Therapy.

12.11 In older adults at increased risk of hypoglycemia, medication classes with low risk of hypoglycemia are

• preferred. B

12.12 Overtreatment of diabetes is common in older adults and should be avoided. B 12.13 Deintensification (or simplification) of complex regimens is recommended to reduce the risk of hypoglycemia, if it can be achieved within the individualized A1C target. B

Older Adults: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S139-S147

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Hypertension/Blood Pressure Control: Lifestyle Intervention.

10.7 For patients with blood pressure >120/80 mmHg, lifestyle intervention consists of weight loss if overweight or obese, a Dietary Approaches to Stop Hypertension (DASH)-style dietary pattern including reducing sodium and increasing potassium intake, moderation of alcohol intake, and increased physical activity. B

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123 Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123

Lipid Management: Statin Treatment (1).

10.19 For patients of all ages with diabetes and atherosclerotic cardiovascular disease or 10-year atherosclerotic cardiovascular disease risk >20%, high-intensity statin therapy should be added to lifestyle therapy. A 10.20 For patients <40 years with additional atherosclerotic cardiovascular disease risk factors, the patient and provider should consider using moderate-intensity statin in addition to lifestyle

• therapy. C

10.21 For patients with diabetes aged 40-75 years A and >75 years B without atherosclerotic cardiovascular disease, use moderate- intensity statin in addition to lifestyle therapy.

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123

Lipid Management: Statin Treatment (2).

10.22 In patients with diabetes who have multiple atherosclerotic cardiovascular disease risk factors, it is reasonable to consider high-intensity statin. C 10.23 For patients who do not tolerate the intended intensity, the maximally tolerated statin dose should be used. E 10.24 For patients with diabetes and atherosclerotic cardiovascular disease, if LDL cholesterol is ≥70 mg/dL on maximally tolerated statin dose, consider adding additional LDL-lowering therapy (such as ezetimibe or PCSK9 inhibitor). A Ezetimibe may be preferred due to lower cost. 10.25 Statin therapy is contraindicated in pregnancy. B

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123 Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123

Lipid Management: Other Combination Therapy.

10.28 Combination therapy (statin/fibrate) has not been shown to improve atherosclerotic cardiovascular disease outcomes and is generally not recommended. A 10.29 Combination therapy (statin/niacin) has not been shown to provide additional cardiovascular benefit above statin therapy alone, may increase the risk of stroke with additional side effects, and is generally not recommended. A

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123

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Lipid Management: Treatment of Other Lipoprotein Fractions or Targets (2).

Based on findings from the Reduction of Cardiovascular Event with Icosapent Ethyl Intervention Trial (REDUCE-IT), an additional recommendation has been officially added with the March 27, 2019 Living Standards of Care update. 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

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123

Antiplatelet Agents.

10.30 Use aspirin therapy (75-162 mg/day) as a secondary prevention strategy in those with diabetes and a history of atherosclerotic cardiovascular disease. A 10.31 For patients with atherosclerotic cardiovascular disease and documented aspirin allergy, clopidogrel (75 mg/day) should be used. B 10.32 Dual antiplatelet therapy (with low-dose aspirin and a P2Y12 inhibitor) is reasonable for a year after an acute coronary syndrome A and may have benefits beyond this period. B 10.33 Aspirin therapy (75-162 mg/day) may be considered as a primary prevention strategy in those with diabetes who are at increased cardiovascular risk, after a discussion with the patient on the benefits versus increased risk of bleeding. C

Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S103-S123

Immunizations (1).

4.7 Provide routinely recommended vaccinations for children and adults with diabetes by age. C 4.8 Annual vaccination against influenza is recommended for all people ≥6 months of age, especially those with diabetes. C 4.9 Vaccination against pneumococcal disease, including pneumococcal pneumonia, with 13-valent pneumococcal conjugate vaccine (PCV13) is recommended for children before age 2 years. People with diabetes ages 2 through 64 years should also receive 23-valent pneumococcal polysaccharide vaccine (PPSV23). At age ≥65 years, regardless of vaccination history, additional PPSV23 vaccination is necessary. C

Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S34-S45

Immunizations (2).

4.10 Administer a 2- or 3-dose series of hepatitis B vaccine, depending on the vaccine, to unvaccinated adults with diabetes ages 18 through 59 years. C 4.11 Consider administering 3-dose series of hepatitis B vaccine to unvaccinated adults with diabetes ages ≥60

• years. C

Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S34-S45

Neuropathy: Treatment.

11.29 Optimize glucose control to prevent or delay the development of neuropathy in patients with type 1 diabetes A and to slow the progression of neuropathy in patients with type 2 diabetes. B 11.30 Assess and treat patients to reduce pain related to diabetic peripheral neuropathy B and symptoms of autonomic neuropathy and to improve quality of life. E 11.31 Pregabalin, duloxetine, or gabapentin are recommended as initial pharmacologic treatments for neuropathic pain in

• diabetes. A

Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S124-S138

Perioperative Care.

Diabetes Care in the Hospital: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S173-S181

Many standards for perioperative care lack a robust evidence base. However, the following approach may be considered:

• 1. Target glucose range for the perioperative period should be 80-180

mg/dL (4.4-10.0 mmol/L).

• 2. Perform a preoperative risk assessment for patients at high risk for

ischemic heart disease and those with autonomic neuropathy or renal failure.

• 3. Withhold metformin the day of surgery.
• 4. Withhold any other oral hypoglycemic agents the morning of surgery
• r procedure and give half of NPH dose or 60-80% doses of long-

acting analog or pump basal insulin.

• 5. Monitor blood glucose at least every 4-6 h while NPO and dose with

short- or rapid-acting insulin as needed.

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Emerging Technologies

There is an increasing call for the use of technology and telemedicine to improve patients’ health. Many types of inputs can be digitalized, such as blood glucose levels, time spent exercising, steps walked, energy ingested, medication doses administered, blood pressure, and weight. Patterns in these variables can be identified by software, leading to specific treatment recommendations supported by real-time algorithms. Telemedicine incorporates multiple types of communication services, such as two way video, e-mail, texting, smartphones, tablets, wireless monitors, decision support tools, and other forms of telecommunication technologies. Results overall suggest a modest improvement in glycemic control.

Continuous Glucose Monitors.

7.10 Sensor-augmented pump therapy may be considered for children, adolescents, and adults to improve glycemic control without an increase in hypoglycemia or severe hypoglycemia. Benefits correlate with adherence to ongoing use of the device. A 7.11 When prescribing continuous glucose monitoring, robust diabetes education, training, and support are required for optimal continuous glucose monitor implementation and ongoing use. E 7.12 People who have been successfully using continuous glucose monitors should have continued access across third-party payers. E

Diabetes Technology: Standards of Medical Care in Diabetes - 2019. Diabetes Care 2019;42(Suppl. 1):S71-S80

Key Knowledge Gaps

Implementation science. The tools available to prevent and treat diabetes are vastly

• improved. However, implementation of effective innovation has lagged behind.

Basic science. Our understanding of the basic mechanisms of diabetes, the development of complications, and the treatment of both, though continuously advancing, has highlighted how much we do not know. Personalized/precision medicine. Though promising, these –omics and big data approaches addressing both personal and environmental factors and their interaction are largely unrealized in diabetes care and will require large investments and coordination to have impact.

• Informatics. The benefits and role of enhanced monitoring of glucose and other

variables leveraged with real-time informatics-based approaches to adapt treatment

• n an individual basis has great potential but has not been elucidated.

Key Knowledge Gaps

Overweight/obesity. Current therapy is clearly inadequate. Innovation in methods and implementation would transform diabetes prevention and care. Understanding the biology, psychology and sociology of obesity to identify pharmacological, behavioral and political approaches to preventing and treating this principal cause of type 2 diabetes is essential Lifestyle management and DSMES. Though the benefits of these approaches are clear, better paradigms on how to target, individualize and sustain the effects are needed. Beta-cell function. Preserving and enhancing beta cell function is perceived as the holy grail of diabetes and yet effective techniques are inadequately developed.

Key Knowledge Gaps

Translational research. There is a huge gap between the knowledge gained from clinical trials and application of that information in clinical practice. Better application

• f ‘real-world evidence’ will complement randomized trial evidence.

Drug development. New medications will require demonstration of broad efficacy for glucose, comorbidities and/ or complications as well as safety and tolerability to compete in the marketplace.

• Complications. Steatohepatitis, HF, non-albuminuric CKD, chronic mental illness and
• ther emerging issues are complications in diabetes that may supplant classical

microvascular and macrovascular disease in importance and impact. Understanding

• ptimal diagnostic, screening and treatment strategies is urgently needed.

Key Knowledge Gaps

Better data on optimal approaches to diabetes management in frail and older adult patients is urgently required considering the controversy around glycemic targets and the benefits and harms of specific treatments from lifestyle management to medications. Current approaches to the management of type 2 diabetes in adolescents and young adults do not seem to alter the loss of beta cell function and most individuals in this age group quickly transition to insulin therapy. Studies to guide

• ptimal therapy in this emerging population with a terrifyingly high risk of early

disability is an immediate need.

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Enduring Questions

Does metformin provide cardiovascular benefit in patients with type 2 diabetes early in the natural history of diabetes, as suggested by the UKPDS study? Is metformin’s role as first-line medication management truly evidence-based

• r a quirk of history? Though the rationale for early combination therapy

targeting normal levels of glycemia in early diabetes is seductive, clinical trial evidence to support specific combinations and targets is essentially non- existent. As the cost implications for these approaches is enormous, evidence is desperately needed. Different models of care are being implemented globally. Defining optimal cost-effective approaches to care, particularly in the management of patients (multi-morbidity), is essential.

New Questions

Do the cardiovascular and renal benefits of SGLT-2 inhibitors and GLP-1 receptor agonists demonstrated in patients with established CVD extend to lower-risk patients? Is there additive benefit of use of GLP-1 receptor agonists and SGLT2 inhibitors for prevention of cardiovascular and renal events? If so, in what populations?

Summary

• Recent clinical trials lay the foundation for

new recommendations

• Decision cycle for DM management updated
• Consensus recommendations from ADA/EASD
• Graphics/Algorithms for medications
• Emerging technologies, key knowledge gaps,

new and enduring questions

• Assess CV status first

Discussion

No more metformin first and then do something else (2012, 2015) First time specific drug recommendations First time adding cost, tolerance, and adherence Not about targets, but how to get there Compare to AACE guidelines How can this change micro/macro comprehensive care plans for us? Conflicts of interest? “Beyond A1c” proponents want more CGM emphasis SU’s? Post-hoc analysis of EXSCEL to mirror LEADER when patient characteristics normalized?

Standards of

Full version available

• Abridged version for

PCPs

• Free app, with interactive

tools

• Pocket cards with key

figures

• Free webcast for

continuing education credit Professional.Diabetes.

• rg/SOC

Thank you!

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