August 12, 2019
By Marilynn Larkin
NEW YORK (Reuters Health) - The American Diabetes Association (ADA) has updated its Standards of Medical Care in Diabetes to include diabetes technology, with recommendations for self-monitoring of blood glucose, continuous glucose monitors and automated insulin delivery systems.
The guidelines, developed by the ADA's Professional Practice Committee based on a review of the literature from 2017-2018, are summarized by Dr. James Chamberlain of St. Mark's Diabetes Center in Salt Lake City and colleagues in Annals of Internal Medicine, online August 12.
"We thought it was extremely important to get this review of the statement on diabetes technology from the ADA in the hands of the people that are providing the majority of the diabetes care in America," Dr. Chamberlain told Reuters Health by email.
"Diabetes technology is changing at a very rapid pace," he noted. "Patients are asking their providers about insulin delivery systems, continuous glucose monitoring (CGM), insulin pumps, and hybrid closed-loop pump products and we believe primary care providers must have at least a basic understanding of these technologies."
Key points of the new section include the following:
- "CGM has revolutionized the ability of (patients) to better manage their diabetes with improvements in glucose averages, less glucose variability, more time spent in range, less hypoglycemia, and less fear of hypoglycemia," Dr. Chamberlain says.
In this regard, the guidelines suggest use of self-monitoring of blood glucose (SMBG) or CGM before meals and snacks; at bedtime; occasionally postprandially; before exercise; when low blood glucose is suspected; after treatment to normoglycemic levels; and before tasks such as driving.
The US Food and Drug Administration's accuracy standard for glucose monitors intended for home use is: 95% of readings need to be within 15% for all blood glucose results in the monitor's readable range, and 99% must be within 20%.
- "Insulin pumps continue to evolve, with improvements in design and usability," Dr. Chamberlain noted. "Insulin pumps are now being combined with CGM technology to create hybrid closed-loop products which allow the pump to automate insulin delivery to a certain degree."
Other recommendations include use of an intermittently scanned CGM as a substitute for self-monitoring of blood glucose in adults with diabetes requiring frequent glucose testing, and consideration of automated insulin delivery systems consisting of an insulin pump, a continuous glucose sensor, and an algorithm that determines insulin delivery for children over age seven and adults with type 1 diabetes.
"We do not yet have fully-automated 'artificial pancreas' systems approved for patient use," Dr. Chamberlain added. As noted in the guidelines, he said, "Providers should be aware that some patients are choosing to use off-label, non-FDA approved 'artificial pancreas' systems to manage their diabetes such as OpenAPS and Loop."
The FDA warned against the use of such unauthorized devices on May 17. (http://bit.ly/33EbqzE)
Dr. Joshua Miller, Assistant Dean for Clinical Integration and Medical Director of Diabetes Care at Stony Brook Medicine in Long Island, New York, commented by email, "While I am delighted to see the ADA expand their recommendations regarding diabetes technology, I would like to see a greater effort in promoting more rapid advancement of and access to this technology."
"The federal government - including the FDA and Centers for Medicare and Medicaid Services - should continue to be urged to support advancement in this area of diabetes care," he said by email.
"As an endocrinologist, I deeply hope that more patients with diabetes will have access to newer diabetes technologies," he said. "As a person living with type 1 diabetes, I am anxiously awaiting the day when technology can help to 'close the loop' in insulin delivery for patients and their families."
Ann Intern Med 2019.
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