Dive Brief:
- Results of a Dexcom-funded study published in the New England Journal of Medicine Wednesday demonstrated that people with Type 2 diabetes who don’t take insulin may benefit from wearing a continuous glucose monitor.
- Dexcom first shared the results at the American Diabetes Association’s Scientific Sessions this summer. The study found that people who wore a CGM had a larger reduction in hemoglobin A1c than people who received routine care after 26 weeks.
- The published results come as diabetes tech firms anticipate the Centers for Medicare and Medicaid Services to expand Medicare coverage of CGMs for people with diabetes who don’t take insulin. Having a peer-reviewed publication in a leading medical journal “should be a catalyst” for a CMS decision, William Blair analysts wrote in a research note.
Dive Insight:
The published study “reinforces the strength and totality of the data,” Leerink Partners analyst Mike Kratky wrote in a note to investors.
The study enrolled 440 people across 22 primary care practices in the U.S., randomly assigning 145 people to use Dexcom’s G7 CGM and 138 people to routine care. People in the CGM group saw their HbA1c levels decrease on average from a baseline 8.8% to 7.2%, while the control group saw a decrease from 8.7% to 8%.
The CGM group also spent five more hours per day in the target blood glucose range of 70 to 180 mg per deciliter.
The benefits were consistent across various demographics including age, sex, race and ethnicity, body mass index, diabetes duration, income, education, health insurance and the use of other glucose-lowering medications, Dexcom said in a summary of the results.
“The fact that almost all participants were still using CGM after 26 weeks and most were using it every day indicates that the participants recognized the benefit of CGM and incorporated it into their daily diabetes management,” Dr. Roy Beck, the study’s senior author and medical director of the JAEB Center for Health Research, said in a Dexcom statement. “Furthermore, the consistency of benefit across a broad range of people and treatment regimens supports consideration of the use of a CGM much earlier in Type 2 diabetes management before insulin is needed.”
Incremental analyses of the data showed the greatest benefit for people with the highest baseline A1Cs, near-elimination of prolonged hyperglycemia and higher medication intensification among CGM users, Leerink’s Kratky wrote.
The timing for the Medicare coverage expansion is still unknown. Dexcom expects a decision before the end of the year, with implementation in mid-2027, Kratky wrote. It would double Dexcom’s total covered lives from about 15 million to 30 million people, Kratky added. Competitor Abbott said this summer that expanded CMS coverage could add about 10 million Medicare beneficiaries.
In total, about 25 million people in the U.S. have Type 2 diabetes and are not on insulin, according to the William Blair analysts.
