The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference.
The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease, according to Fridley, Minn.-based Medtronic. It also enables patients to program insulin action time from two to eight hours, and has an adjustable target setting as low as 100 mg/dL. The MiniMed 780G won the CE Mark this week, but has not been approved for use in the U.S.
The 90-day at home U.S. pivotal trial included patients aged 14 to 75 years old and yielded no severe adverse events, according to the company. The trial results include:
- No severe hypoglycemia and diabetic ketoacidosis.
- Average A1C of 7.0%.
- Overall time in range (defined as 70-180 mg/dL) of 75%, with overall time below range (defined as less than 70 mg/dL) of 1.8%.
- Overnight time in range of 82%, with overnight time below range of 1.5%.
- Autocorrection contributing to 22% of all bolus insulin.
- Participants being in SmartGuard (closed loop) 95% of the time.
- Mean sensor glucose (SG) of 148 mg/dL overall, and 144 mg/dL at the default 100mg/dl target.
Results from a study questionnaire showed that 96% of users found it easy to use. System requests for fingerstick blood sugars were also reduced by 46% when compared to the MiniMed 670G system. Lastly, the lower target glucose and active insulin time (AIT) settings substantially improved time in range, without increasing hypoglycemia, according to Medtronic. Time in range increased to76%, with a 100 mg/dL target and AIT of two to three hours, and reached 79% when AIT was set to two hours. Results across all pump settings exceeded ADA and ATTD international clinical consensus Time in Range guidelines, the company added in a news release.
“The results of the study are exciting and are a welcome addition to what we have seen with other advancements in automated insulin delivery systems,” said principal investigator Dr. Anders Carlson, medical director of the Park Nicollet International Diabetes Center in Minneapolis. Most notable is the additional target glucose level of 100 mg/dL — which will be lower than the other commercially available devices in this category and likely contributed to the demonstrated improvements in study outcomes, namely time in range and A1C.
Data from a second, randomized cross-over clinical trial was also presented at the meeting. This trial was based in New Zealand and studied a more challenging patient group, including those with less-controlled diabetes and a younger patient population of children as young as seven years old.
The study met primary endpoints (increasing overall time in range), as well as secondary endpoints (decreasing overall time above and below range). The results included:
- A 13-point overall improvement in Time in Range to 70.4%.
- A 0.4% overall decrease in Time Below Range (70mg/dL)to 2.1%.
- A 16% improvement in Time in Range overnight, due in large part to a 12% reduction in hyperglycemia.
- A 13.0% improvement in Time in Range to 70.2% at the default 100mg/dl target.
- Autocorrection contributing to 21% of all bolus insulin.
- Participants being in SmartGuard (closed loop) 95% of the time.
- Mean SG improvement of 10 mg/dL overall.
Patients also reported being highly satisfied with their experience overall, with 95% agreeing that the system was easy to use and 85% agreeing that the system improved their quality of life.
“We wanted to design a system that further simplifies diabetes management and provides an extra layer of protection for the times one may forget a pre-meal bolus or miscalculate their carbohydrates,” said Dr. Robert Vigersky, chief medical officer for the Diabetes Group at Medtronic. “The combination of these two study findings, across a broad spectrum of patients at various levels of glucose control, are promising — they demonstrate that the smart automation featured in this next-generation system has tremendous potential for meaningfully reducing burden and enhancing quality of life.”