Next-generation artificial pancreas boosts time in range for children with diabetes
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Children with type 1 diabetes who used an advanced hybrid closed-loop insulin delivery system for 1 year achieved an average time in range of 74%, surpassing clinical consensus guidelines, according to European data released by Medtronic.
Real-world clinical data from 3,211 pediatric and adolescent patients with type 1 diabetes using the MiniMed 780G system with the Guardian Sensor 3 also showed that an average overnight time in range of 82% mirrored that of adults, demonstrating that the advanced hybrid closed-loop algorithm offers protection against overnight hypoglycemia, the company stated in a press release.
The MiniMed 780G system, available in 38 countries across Europe, the Middle East and Africa and currently under FDA review for approval in the U.S., delivers near real-time basal insulin and auto correction boluses (every 5 minutes) to address underestimated carb counts and occasional missed meal doses.
“The Medtronic advanced hybrid closed-loop algorithm offers advanced protection and permits unprecedented personalization in insulin delivery by offering a wide range of Active Insulin Time settings and three different glucose targets,” Robert Vigersky, MD, chief medical officer of the diabetes business at Medtronic, said in the release. “These improvements reinforce that the MiniMed 780G system is a better alternative than previous therapy these patients were on, even for those who were relatively well controlled.”
In the release, the company said younger users remained in advanced hybrid closed-loop mode, also referred to as the SmartGuard algorithm, for an average of 93% of the time, similar to the 92% observed in adult users. When the pediatric group set a blood glucose target of 110 mg/dL and an active insulin time of 2 hours, they achieved an average time in range of 77% and a glucose management indicator (GMI) of 6.7%. With these settings, they only spent 2.7% of their time in hypoglycemia.
The real-world performance analysis aggregates information from children aged 15 years and younger whose caregivers agreed to allow Medtronic to use anonymized data that were automatically uploaded to CareLink Personal from Aug. 27, 2020, to July 22, 2021. Most pediatric users included in the analysis are achieving glycemic goals recommended by major diabetes professional organizations, including 75.3% of pediatric users with a GMI less than 7%, which mirrors the average HbA1c level that would be expected based on mean glucose.
A subanalysis of children aged 15 years and younger with at least 10 days of continuous glucose monitoring data both pre- and post-advanced hybrid closed-loop initiation (n = 661) showed substantial improvements across both time in range and GMI, even among those relatively well controlled at baseline. This group saw a 12% increase in time in range to 74% on average — equivalent to an additional 2.8 hours per day in the target range. Results also showed patients were able to stay in advanced hybrid closed-loop mode 93% of the time once initiated.
“We know that adolescents in particular lead very active lives and often eat on the go — running from one activity to the next,” Julie Foster, vice president of customer experience for the diabetes business at Medtronic, said in the release. “This system was designed to help individuals living with diabetes have some extra coverage and protection when life gets in the way and they’re not able to manage their diabetes in the way they’d like to.”
The MiniMed 780G system is the most advanced insulin pump system from Medtronic, currently approved for the treatment of type 1 diabetes in people aged 7 to 80 years. The system enables the personalization of glucose goals with an adjustable target setting as low as 100 mg/dL.
As Healio previously reported, the FDA approved the Medtronic MiniMed 770G system, a next-generation hybrid closed-loop insulin delivery system for children aged 2 to 6 years with type 1 diabetes, in September 2020. The 770G system, which builds on the success of Medtronic’s 670G, is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from users or their caregivers; it is the first legally marketed device that can automatically adjust insulin delivery based on CGM for a young pediatric population.
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