For 2020, the American Diabetes Association (ADA) is making two paradigm-shifting recommendations to expand the use of newer glucose-lowering drugs in patients with type 2 diabetes.
Also new and noteworthy in the Association's Standards of Medical Care in Diabetes — 2020, published online December 20 in Diabetes Care, is a subsection on the management of type 1 diabetes in older adults and new A1c target recommendations for children and adolescents.
For 2020, ADA is now advising clinicians to consider prescribing sodium glucose co-transporter 2 (SGLT2) inhibitors or glucagon-like peptide 1 (GLP-1) receptor agonists to patients at high risk for atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease (CKD), in addition to patients with already established disease, as previously recommended.
And ADA now advises that consideration for use of those drugs be independent of the patient's baseline A1c or individualized A1c target. Previously, additional pharmacologic agents were recommended only when A1c was above target despite using first-line metformin and lifestyle interventions.
The new guidance (in section 9) was based on analyses from cardiovascular outcomes trials that included patients at high risk in addition to those with established disease and those with only modestly elevated A1c, such as the REWIND trial of the GLP-1 agonist dulaglutide (Trulicity, Lilly), ADA Professional Practice Committee chair Joshua J. Neumiller, PharmD, CDE, told Medscape Medical News in an interview.
"We decided, based on looking at all the evidence, to say that, if people are at risk, we should consider using these agents in them as well [as those with established disease], and not only based on glucose-lowering effect...This is a pretty new concept," said Neumiller, who is vice chair and Allen I. White distinguished associate professor of pharmacotherapy at Washington State University, Spokane.
"I think this is going to be a paradigm change...I think there will be a huge need for education on this particular recommendation and how to implement it in practice," he added.
The recommendation has also been incorporated into the 2020 revision of the joint ADA/European Association for the Study of Diabetes consensus statement on the management of hyperglycemia in type 2 diabetes, published December 19 in Diabetes Care and Diabetologia.
And for the second year in a row, the section on cardiovascular disease and risk management (section 10) is endorsed by the American College of Cardiology.
New for Type 1 Diabetes: Older Adults, New A1c Target for Kids
The 2020 Standards of Care has added a new subsection on type 1 diabetes to the section on older adults (section 12), given that people with type 1 diabetes are living longer and have distinctive health needs from those with type 2 diabetes.
"A lot of the discussion in the older adults section was about simplification...so it was important to emphasize some of the caveats related to type 1 diabetes where they need to be on insulin, emphasizing caregiver and family involvement and having champions for the patient when they transition to long-term care and other facilities where providers may be less familiar with the management of type 1 diabetes," Neumiller said.
"I think that's a very important update this year," he stressed.
For children and adolescents, the overall general A1c target of 7.5% has been changed to 7.0%. But, as in the past, the target should be individualized up or down based on the needs and situation of the patient and family.
"This is now better aligned with what we say for adults, with individualization. It gives providers a bit more granularity in picking targets...We now say a general target is less than 7% for many children, but more or less stringent in certain situations," he said.
Information on Technology and Other 2019 Updates Incorporated
Several new additions have also been provided addressing use of diabetes technology (section 7), with a re-organization into three subsections on self-monitoring of blood glucose, continuous glucose monitoring (CGM), and insulin delivery. Based on the 2019 consensus report on time in range and ambulatory glucose profiles, new recommendations have been added for use of those data in glycemic management.
"I think this will be very helpful for providers, particularly now that we're seeing much more CGM use in a broader type 2 diabetes population," Neumiller said.
The 2020 document also incorporates previous real-time "living standards" updates made in March and August 2019, as well as new developments that have occurred since August, including approval of the first oral GLP-1 agonist, semaglutide (Rybelsus, Novo Nordisk).
"Huge Issue" of Cost Considerations Addressed Throughout
Scattered throughout the document are references to financial considerations that pose barriers to patients' abilities to access recommended therapies.
These include additional information about the cost of medications, particularly insulin, in the section on improving care and promoting health in populations (section 1), and use of nonanalog insulins (Figure 9.2) in the section on therapy intensification.
"We've tried to include additional guidance and information on best practices on these more affordable products for those who unfortunately can't afford the newer products. It's a huge issue," Neumiller commented.
And regarding the high cost of the newer type 2 diabetes agents now more widely recommended, he said, "We make recommendations based on the evidence. Certainly, payment is always a piece of the discussion. But a lot of those decisions are made based on the guidance...I think this is one of those major changes that will spark a discussion on the payer side as well as the practical clinical use side, and we'll just have to see how it's implemented."
Overall, Neumiller said of the 2020 Standards, "I hope clinicians will find the new figures and tables, and guidance on use of CGMs and technology, helpful."
"And I definitely hope that the primary care, as well as endocrinology audiences, will consider the new data and recommendations for glucose-lowering therapies in patients at risk for cardiovascular disease and renal disease and really start a discussion about how to implement use of these therapies in people who may be at A1c goal. I think it's going to spark a discussion, and I'm really interested to see how it plays out."
Diabetes Care. Published online December 20, 2019. Full text
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