Research shared by Dexcom at the American Diabetes Association’s Scientific Sessions last weekend showed that people who have Type 2 diabetes but don’t take insulin could still benefit from wearing a glucose sensor.
Dexcom telegraphed the study results ahead of the conference in a May earnings call, with CEO Jake Leach saying he expected the results could support a Medicare coverage decision “between now and the end of this year.”
Thomas Martens, a medical director at the International Diabetes Center in Minneapolis and co-author of the study, said the research was intended to answer the question of whether continuous glucose monitors, or CGMs, can improve diabetes management for people who don’t take insulin. The study was funded by Dexcom.
About 20 million people in the U.S. currently manage their Type 2 diabetes without insulin, Martens said in an interview.
The randomized, controlled trial, which followed 265 people over 26 weeks, compared people who used Dexcom’s G7 CGM with those who self-monitored their blood glucose using finger sticks. The control group was told to check their glucose as frequently as their clinicians advised, doing a median of roughly three finger sticks per week, Martens said.
People who used the CGM had an average hemoglobin A1C reduction of 1.6% from the baseline level of 8.8%. The result was a 0.9% greater A1C reduction than the control group, which Martens said was “striking.”
People who used the CGM also had better time in range, a measure of how much time during the day a person stays within a target blood glucose range. The Dexcom G7 users had a 62% time in range compared with 41% in the control group.
“CGM is a useful technology, it looks like, across the board in people with diabetes,” Martens said.
The study did not describe what changes may have led to the result. Martens said that retrospective CGM data can be useful for clinicians in assessing whether a person needs adjustments in medications, and real-time data can help users see the impact of things like what they ate for breakfast.
Many insurers look to the ADA’s standards of care for diabetes, Martens added. Currently, CGMs have level A evidence for people who use insulin to manage their diabetes, making the devices the standard of care.
For people with diabetes who don’t take insulin, CGMs have level C evidence, signaling a lack of high-quality randomized, controlled data.
“I think there is potential for this to increase the strength of the grade of evidence supporting using CGM for people not on insulin,” Martens said.
If the ADA strengthens its rating, it could have downstream effects for Medicare coverage and private payers, he added, removing some financial barriers for people with diabetes.
“We would love for it to be as level a playing field as possible,” Martens said.
