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ADA 2016

Dexcom's Evidence Builds Case for CGM Dosing Ahead of Key FDA Meeting

Mary Caffrey
The diabetes advocacy community has long sought Medicare coverage for continuous glucose monitoring (CGM) systems, but the technology has been deemed "precautionary." Abstracts presented at last week's ADA Scientific Sessions could help build a case for updating FDA's clearance to use CGM for dosing, removing a hurdle to Medicare coverage.
You won’t find the terms “FDA” or “Medicare” in the studies that Dexcom presented this past weekend in New Orleans at the 76th Scientific Sessions of the American Diabetes Association (ADA). But evidence the company offered on continuous glucose monitoring (CGM) has everything to do with an upcoming FDA advisory panel meeting, which could lead to a longtime goal of the diabetes advocacy community: securing Medicare coverage for CGM.1
Collectively, the Dexcom abstracts showed that (1) patients who engaged more frequently with their CGM device had better glucose control,2,3 (2) patients who set their low-glucose alerts (LGL) at lower levels had less variation in glucose,2 and (3) those who use CGM consistently perform fewer blood glucose tests, but have better glycemic control.3
This last point is critical: today, FDA considers CGM systems adjunctive technology, which means a blood glucose test is still required before each insulin dose. In the real world, however, many patients use CGM for treatment decisions. The July 21, 2016, meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel will take up the question of whether Dexcom’s G5 Mobile system should be cleared for dosing, as it is in Europe.4,5 If that happens, advocates for the T1D community believe it could lift the barrier to Medicare coverage, and Dexcom officials have indicated the change could make a difference.
Technology Is Much Improved
Lori Laffel, MD, MPH, chief of the pediatric, adolescent and young adult section of Joslin Diabetes Center, told The American Journal of Managed Care that the FDA hearing comes after an evolution in CGM technology. While “early adopters” did see improved glycemic control, there were problems with accuracy and usability that led to inconsistent use, she said. Today, however, “the devices have achieved substantial improvement in performance, with accuracy that is achieving that found in blood glucose monitoring with traditional finger sticks.”
The result is more consistent and sustained use, she said. In commenting on a Dexcom abstract that analyzed several CGM studies, Laffel said that if patients taking part in a study—who were told to check their blood glucose—decreased daily blood tests by up to 50%,3 “the speculation here is that patients must have been using CGM to make treatment decisions.”
Tomas Walker, DNP, APRN, CDE, director of clinical projects for Dexcom and the lead author or co-author on several studies presented at ADA, agreed with Laffel that improved technology has been key to more consistent use among patients.
“As someone who had a clinical practice for 17 years, I am amazed at how rapidly patients have taken to this technology and incorporated it into the way they manage their diabetes,” Walker said.
From his perspective, an expansion of FDA clearance would open the door to discussions among Dexcom, providers, and patients about when it is appropriate—and not appropriate—to use CGM for dosing. “It’s time to start having those conversations,” he said.

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