Tandem Diabetes Care has received Europe’s CE mark for an expanded label of its automated insulin delivery systems.
The update would allow people with Type 2 diabetes to use Tandem’s devices, as well as people with Type 1 diabetes during pregnancy, according to the Friday announcement.
Automated insulin delivery, or AID, systems use a glucose sensor and a connected insulin pump to predict and deliver needed insulin. The expanded label applies to Tandem’s t:slim X2 insulin pump, as well as its smaller Mobi pump.
Tandem said the decision to allow pregnant people to use the systems was based on results from its Circuit trial, which was published in JAMA last year. The randomized, controlled trial compared people who used Tandem’s t:slim X2 pump with its Control-IQ+ software with people who used an insulin pump or injections with glucose monitoring. The group that used Tandem’s system experienced 12.6% more time in the target glucose range.
Tandem presented the results of the trial at the American Diabetes Association’s Scientific Sessions last weekend.
The expanded label for people with Type 2 diabetes was based on a randomized, controlled trial of more than 300 people published in the New England Journal of Medicine last year. People who used Tandem’s AID system achieved a larger reduction in hemoglobin A1C levels than the control group, who continued their existing insulin regimen. Tandem funded the study.
Insulet presents data on next insulin pump
Insulet shared results from the Strive pivotal study of its next insulin patch pump, the Omnipod 6, at the ADA conference on Saturday.
The randomized crossover study included 132 participants in the U.S. with Type 1 and Type 2 diabetes, comparing people who used the company’s current Omnipod 5 device and the planned Omnipod 6.
People who used the Omnipod 6 had a slightly lower target glucose level, at 100 mg/dL, than those on the Omnipod 5, at 110mg/dL. The company found an improved time in range for people with Type 1 diabetes and Type 2 diabetes who used the Omnipod 6, at 77% and 76% respectively. People who used the Omnipod 5 had 73% time in range. Time in range is a measurement of how much time in a day a person spends in the target blood glucose range.
At the end of the crossover study, Insulet included an optional phase to evaluate where glycemic outcomes could be maintained if users bolused less frequently ahead of mealtimes. For both groups, time in range was above 70%.
Insulet also presented early results of a new AID system that it is developing to allow people to skip mealtime boluses. The system would only be for people with Type 2 diabetes.
Insulet said people who used the system had a time in range of 64%, a 12% improvement above baseline, with low hypoglycemia. In May, Insulet started enrolling participants in a pivotal trial of the system.
Dexcom finds glucose sensors reduced A1C in people who don’t take insulin
Dexcom found people with Type 2 diabetes who don’t take insulin benefited from its glucose sensors in a randomized controlled trial. The company presented the results of its Connect study at the ADA on Saturday.
Dexcom compared people with Type 2 diabetes not using insulin who wore its G7 glucose sensors with people who self monitored blood glucose. People who used Dexcom’s device had an average A1C reduction of 1.6% over 26 weeks, which was better than the control group. The Dexcom users also spent five more hours per day than the control group in their target glucose range.
Roy Beck, medical director of the Jaeb Center for Health Research and senior author of the study, said in a statement that the results provided level A evidence, the ADA’s highest level of evidence, on the benefits of continuous glucose monitors for Type 2 non-insulin users.
Dexcom CEO Jake Leach added that he expects the results to drive a new standard of care in the U.S. and around the world for people with Type 2 diabetes.
