Standards of Care Updates from the ADA

By Divya Gopisetty

ADA now much more assertively recommends of GLP-1 agonists and SGLT-2 inhibitors for people that have heart and kidney problems– they also recommend earlier combination therapy in type 2 diabetes, GLP-1 as first-line injection therapy (that means before insulin), nasal glucagon, using time in range to assess diabetes management, and CGM to avoid hypoglycemia

The American Diabetes Association (ADA) recently made important updates to its 2020 Standards of Medical Care – a very influential and helpful document that provides healthcare professionals, researchers, and insurers with recommendations and guidelines for diabetes care. The guidelines aim to provide the most current, scientifically backed recommendations for diabetes care.

In therapy, the new updates include:

• The recommendation of GLP-1 agonists and SGLT-2 inhibitors for heart and kidney protection in people with type 2 diabetes, regardless of A1C level;

• The decision to keep metformin as the recommended first-line therapy in type 2 diabetes (unlike the European Society of Cardiology);

• The recommendation of earlier combination therapy (DPP-4 inhibitor and metformin) for people with type 2 diabetes as a result of VERIFY;

• The recommendation of GLP-1 agonists as first-line injection therapy over insulin for people with type 2 diabetes;

• The addition of Rybelsus (oral Ozempic) for type 2, and nasal glucagon Baqsimi and liquid glucagon injection GVOKE for type 1.

In technology, the new updates include:

• The inclusion of time-in-range goals and metrics for people using continuous glucose monitors (CGM);

• The mention of CGM for hypoglycemia (low blood sugar) prevention;

• The statement that there is no “one-size-fits-all” approach for diabetes technology.

GLP-1 agonists and SGLT-2 inhibitors are recommended for high-risk individuals with type 2 diabetes, regardless of A1C levels, to:

• Reduce risk of heart attack, stroke, and other major adverse cardiovascular events (MACE);

• Reduce the risk of hospitalization for heart failure;

• Reduce the risk of heart-related death;

• Slow the progression of chronic kidney disease (CKD).

What does this mean?

It means that the approximately 30% of people with type 2 diabetes who currently have heart disease or kidney problems – no matter their A1C – should go on either an SGLT-2 inhibitor or a GLP-1 agonist. This recommendation follows evidence from many trials showing that the glucose-independent effects of these therapies reduce the risk of heart and kidney complications.

These updates are posted in chapter 10 of the 2020 ADA Standards of Care.

Metformin, in combination with lifestyle changes, remains as the first-line therapy recommendation for people with type 2 diabetes.

Metformin is effective, safe, and inexpensive, and it may reduce the risk of heart-related events and death. However, the 2019 ESC guidelines recommended SGLT-2s and GLP-1s as first-line drugs over metformin in people with diabetes who have heart disease or a high risk for heart disease. We asked noted endocrinologist Dr. John Buse of UNC for more information. He said that taking GLP-1 or SGLT-2 drugs is about a “compelling indication” rather than the “order” of medications. The world of diabetes therapy is changing: healthcare professionals now not only target “glycemic” health, as in A1C or time in range, but also focus significantly on heart and kidney health.

These updates are posted in chapter 9 of the 2020 ADA Standards of Care.

Combination therapy of DPP-4 inhibitor and metformin is recommended in early treatment of type 2 diabetes.

The VERIFY study investigated the benefits of a combination drug – metformin with DPP-4 inhibitor (Galvus) in a single pill – versus metformin taken alone. The study compared the impact of the treatments on the delay or prevention in the rise of A1C among 2,000 people recently diagnosed with type 2 diabetes. The combination drug delayed the rise in A1C to above 7% by a whopping 26 months, compared to metformin alone (62 months, versus 36 months). Treatment with the combination drug also delayed the need for insulin therapy.

This study shows that a metformin and DPP-4 inhibitor combination therapy is beneficial compared to metformin alone at the beginning of drug treatment for type 2 diabetes. By using two drugs at once, combination drugs can target several mechanisms within the body to lead to greater protection of insulin producing beta cells.

These updates are posted in chapter 9 of the 2020 ADA Standards of Care.

GLP-1 agonist medication is recommended as a first-line injection therapy over insulin.

Consistent with the 2019 update to the Standard of Care, GLP-1s are recommended ahead of basal insulin when considering injectable therapies. This recommendation reflects the field’s understanding that GLP-1 agonists have a similar glucose-lowering effect to insulin. GLP-1s are preferred because they have a lower risk of hypoglycemia and a greater potential for weight loss. On the flip side, however, GLP-1s are notably more expensive than insulin and are not always tolerated well by the body (sometimes causing nausea and gastrointestinal side effects that tend to decrease over time).

These updates are posted in chapter 9 of the 2020 ADA Standards of Care.

Oral semaglutide, Rybelsus, (a pill version of GLP-1 agonist Ozempic) was mentioned as a potential treatment option for type 2 diabetes. Nasal glucagon Baqsimi and liquid glucagon injection GVOKE were included for the treatment of hypoglycemia in both type 1 and type 2 diabetes.

The approval of Rybelsus brings more options for people with type 2 diabetes to access the significant benefits of GLP-1s, namely lowering A1C and prompting weight loss. In addition, all the data from clinical trials shows that both Rybelsus (pill) and Ozempic (injection) semaglutide can benefit heart health: they significantly reduce the risk for heart attack, stroke, and heart-related death. Click here to learn more about the benefits of Rybelsus. Notably, Rybelsus must be taken 30 minutes before the first food, drink, or medication of the day.

The FDA approval of Baqsimi and GVOKE provides people with an alternative to current glucagon kits for hypoglycemia. As in previous Standards of Care, caregivers should be trained and prepared to administer glucagon in emergency situations, and we know these new products are easier for many people to use and administer in stressful situations.

In diabetes technology, time-in-range goals and metrics for people using continuous glucose monitors (CGM) have been included, as we saw in the 2019 update. The range used and time-in-range goal should vary based on the person with diabetes (see below). No matter where someone is starting, every 5% improvement in time-in-range – e.g., going from 60% to 65% – is considered meaningful, as that’s one more hour in-range per day. You can read more from diaTribe about time-in-range here.

• For a person with type 1 or type 2 diabetes, the goal is to be in the target range (70-180 mg/dl) more than 70% of the time, with less than 4% spent in hypoglycemia (under 70 mg/dl). Some people with diabetes choose to use a tighter range of 70-140 mg/dl, though 70-180 mg/dl is a good starting point for many.

• For older or high-risk people with diabetes, the goal is to spend more than 50% of time in range, with less than 1% of time in hypoglycemia.

• For pregnant women with type 1, the goal is more than 70% of time in the tighter range of 63-140 mg/dl. (This is shown to lower the risk of newborn complications.)

• For pregnant women with gestational and type 2 diabetes, the goal is to spend the majority of the day in the tighter range of 63-140 mg/dl.

In addition, CGM metrics associated with the AGP (mean glucose, glucose management indicator, glycemic variability, time-in-range, etc.) are included, allowing people living with diabetes and their healthcare professionals to act on the data that the AGP provides. Real-time CGM was also discussed as a tool for hypoglycemia prevention.

The Diabetes Technology chapter emphasizes that there is no “one-size-fits-all” approach to diabetes care. Insurance coverage, people’s preferences, and providers’ ability to stay up-to-date on the latest tools are just a few variables that are discussed. This was the impetus behind DiabetesWise.org (which we wrote about in 2019), a resource that is designed to help individuals with diabetes find the technology that will work best for their preferences and lifestyle.

These updates are posted in chapter 7 of the 2020 ADA Standards of Care. We strongly encourage you to share the updates that you are most curious about with your healthcare professional!

This article is part of a series on time in range. 
 
The diaTribe Foundation, in concert with the Time in Range Coalition, is committed to helping people with diabetes and their caregivers understand time in range to maximize patients' health. Learn more about the Time in Range Coalition here.