The new guideline comes as FDA weighs an advisory panel recommendation for CGM dosing, which many see as a first step toward Medicare coverage.
The Endocrine Society has deemed continued glucose monitoring (CGM) systems the gold standard for adults with type 1 diabetes (T1D), which weight to its call for Medicare to cover the technology for patients age 65 or older.
The society’s new clinical practice guideline, published online ahead of its appearance in the November issue of The Journal of Clinical Endocrinology & Metabolism, comes as the FDA weighs a July recommendation from an advisory panel to approve Dexcom’s G5 Mobile CGM system for dosing, which many see as a first step toward Medicare extending broad-based access to the T1D population. While most commercial plans cover CGM for adults through age 64, once T1D adults enter Medicare, automatic access ceases. Only a handful of beneficiaries have been able to gain coverage through lengthy appeals.
An estimated 1.25 million Americans have T1D—a small share of the 29 million who have diabetes. While some with type 2 diabetes (T2D) use CGM, it is considered a more essential technology for those with T1D, who must use insulin daily because their body fails to produce the hormone that processes blood sugar in the body. CGM systems track patters of glucose levels in the body around the clock and are designed to set off alarms to warn patients (or parents of young patients) when glucose levels are trending too high or too low.
Because CGM gives patients information about glucose patterns, they offer a more complete picture for patients to use when making insulin dosing decisions, compared with traditional finger stick blood tests, which offer a snapshot.
“Studies have found that people with T1D who use CGMs are able to maintain better control of their blood sugar without increasing episodes of hypoglycemia when blood sugar drops to dangerous levels, compared to those who self-monitor blood glucose with periodic finger sticks,” said Anne L. Peters, MD, of the University of Southern California’s Keck School of Medicine, who chaired the task force that authored the guideline. “Scientific evidence supports the use of CGM technology in individuals with T1D whose blood sugar is above the targeted level, as well as those whose blood glucose is well managed.”
The task force noted that those who use CGM must be able and willing to use the monitors, and Dexcom officials have said that those who use the technology must commit to calibrating them twice a day. But patients and parents who testified at a day-long FDA hearing this summer, said for those who succeed with CGM, it offers peace of mind and the ability to take part in daily activities. The task force said CGMs can be used occasionally for T2D patients who are having difficulty getting blood glucose levels into targeted levels. Also, the task force recommended insulin pumps over multiple daily injections for those who are experiencing frequent hypoglycemia or glucose variability.
Members of the Endocrine Society task force include: Andrew J. Ahmann of Oregon Health and Science University in Portland, Oregon; Tadej Battelino of the University of Ljubljana and University Children’s Hospital in Ljubljana, Slovenia; Alison Evert and Irl B. Hirsch of the University of Washington Medical Center in Seattle, Washington; M. Hassan Murad of the Mayo Clinic Evidence-based Practice Center in Rochester, Minnesota; William E. Winter of the University of Florida in Gainesville, Florida; and Howard Wolpert of the Joslin Diabetes Center and Harvard Medical School in Boston, Massachusetts.
The guideline was co-sponsored by the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology. Other professional associations that have previously supported the use of CGM systems for those with T1D are the American Association of Clinical Endocrinologists and the American Diabetes Association.
Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology—continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an Endocrine Society Clinical Practice Guideline [published online September 26, 2016]. J Clin Endocrinol Metab. 2016. DOI: http://dx.doi.org/10.1210/jc.2016-2534