Guidelines that affect diabetes care come from many places: professional societies, advocacy groups, and regulators weigh in on when to use certain drugs and what standards should apply for medical devices. Whether they represent updates to existing standards or cover new ground, guidelines not only affect clinical decisions, but they also drive coverage decisions by payers—and thus, access for patients.
The relationship between obesity and diabetes, and the recognition that unmet behavioral health needs affect outcomes drove updates in 2016. Below are some key changes that will affect both diabetes care and payer decisions going into the new year:
AACE/ACE issue joint update on type 2 diabetes algorithm.
The year began with an update
from the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) on care of patients with type 2 diabetes (T2D). The statement emphasized the need to improve lifestyle management first, to individualize both targets for glycated hemoglobin (A1C) and therapy regimens, based on factors that included cost and likelihood of adherence. Evaluating “cost” must go beyond the price of medication and factor in monitoring, hypoglycemia risk, and likelihood of weight gain.
Endocrinology groups weigh in on SGLT2 inhibitors:
On April 15, 2016, AACE and ACE published a joint statement
on diabetic ketoacidosis (DKA); the statement said the condition does not occur more frequently among patients with T2D taking sodium glucose co-transporter-2 (SGLT2) inhibitors than it does generally. This statement was based on a meeting of leaders in the field that convened to examine evidence after FDA issued a warning in May 2015 that said SGLT2 inhibitors could cause DKA. The endocrinologists found that this powerful and popular drug class was safe for its approved use, and that reports of DKA involved patients with type 1 disease (T1D) involved in clinical trials or patients with atypical T2D who need multiple insulin doses a day.
AACE issues obesity guidelines.
Four years after declaring obesity a disease—a precursor to the headline-grabbing decision by the American Medical Association to the same—AACE in May issued guidelines
to increase understanding of the “multidimensional pathophysiology of obesity,” with genetic, environmental, and behavioral elements. The guidelines addressed 9 clinical questions and featured 123 recommendations and 160 specific statements to address obesity as a “complex, adipose-based chronic disease.” The guidelines came as more groups, including the American Association of Diabetes Educators, featured presenters at annual meetings who discussed the stigma surrounding obesity treatment and payer coverage. Notably, AACE said the goal of obesity care is to bring relief from complications, not just to help patients lose weight.
ADA presents guidelines for use of surgery.
On the heels of the AACE obesity guidelines came the June issue of Diabetes Care
and the statement
from the American Diabetes Association (ADA) and other organizations on when bariatric surgery is appropriate to treat type 2 diabetes (T2D). The ADA even coined a new name for the procedure, calling it “metabolic” surgery, to make clear that weight loss is not the only, or even primary, goal. Improved glycated hemoglobin (A1C) from surgery has been demonstrated in multiple clinical trials. In 32 separate recommendations, the ADA also addressed surgery for type 1 disease and surgery for pediatric patients. The guidelines note that evidence shows surgery produces declines in A1C even among patients who were less obese, and thus had fewer pounds to lose.
FDA issues final guidelines for glucose meter accuracy.
This October document
was a long-awaited by advocacy groups, who said that despite recent technological advances, the basic accuracy of blood glucose meters and test strips hadn’t improved in years. FDA announced the final rule after a lengthy process that took input from patients and from manufacturers. The back story here is important: while FDA was doing this work, CMS was under fire for a Medicare competitive bidding program
that was found to have left some patients with supplies of defective test strips. FDA claims 2 new sets of standards, which cover clinical settings and personal use, will ensure patients have more accurate meters in the years to come. Commentators in the diabetes community praised the effort
, including new labeling requirements to identify the product lot and allow patients to compare brands.
Psychosocial care statement from ADA.
In November, the ADA issued a full statement
on the need to integrate mental health treatment and assessments of cognitive status into diabetes care. The statement was keyed at primary care providers, who are most likely to care for those with T2D. The statement called for bringing other caregivers and family members into the process, for better data sharing, and for greater attention to cultural influences that affect outcomes. The statement specifically discussed diabetes distress, which arises from the constant demands of managing the disease. ADA spelled out needs for specific age groups, from teenagers to seniors.
Lifestyle the focus of 2017 ADA Standards of Care.
In mid-December, ADA issued its annual update to the Standards of Medical Care in Diabetes,
which overhauled and renamed the section on lifestyle management and called for interrupting long periods of sitting with bursts of activity every 30 minutes. The update featured a scientific statement on the differentiation of T1D and T2D, statements on the high cost of insulin, and recommendations for 2 diabetes therapies that can also prevent cardiovascular events: empagliflozin and liraglutide. The 2017 Standards
incorporate earlier recommendations on psychosocial care and use of surgery.