Medtronic's next-generation automated insulin delivery system, the MiniMed 780G, has received a CE mark for the treatment of type 1 diabetes in people aged 7 to 80 years, which means it can be marketed in the European Union.
Such systems track blood glucose using a continuous glucose monitor and automatically deliver insulin when needed using an insulin pump.
Two new features of the MiniMed 780G Advanced Hybrid Closed Loop System, compared with the MiniMed 670G, are Bluetooth connectivity and automated bolus correction doses in addition to basal insulin every 5 minutes, which uses the company's SmartGuard algorithm.
Thus, users still need to count carbs and calculate their pre-meal bolus doses of insulin, but if they forget or miscalculate, the system automatically corrects it to target without user input. The adjustable blood glucose target can be set as low as 100 mg/dL, compared to the previous 120 mg/dL. And as with the 670G, the 780G will still suspend insulin delivery for a predicted low glucose level.
The 780G, which uses technology from DreaMed Diabetes, includes Bluetooth connectivity so that patients and other designated users can see glucose levels and trends in real-time on compatible iOS and Android smartphone apps. And there are fewer settings that healthcare providers need to adjust than for previous systems.
"By continuing to increase the automation of insulin pump systems, we can further reduce burden for people living with diabetes while simultaneously driving positive clinical outcomes," said Moshe Phillip, MD, director of the Institute for Endocrinology and Diabetes, National Center of Childhood Diabetes, Schneider Children's Medical Center of Israel, and cofounder and chief science officer, DreaMed Diabetes, in a Medtronic statement.
Later today during the virtual American Diabetes Association (ADA) 80th Scientific Sessions, data will be presented from the pivotal study submitted for the CE mark, the New Zealand Advanced Hybrid Closed-Loop (AHCL) randomized crossover trial.
During the same session, results of the US AHCL pivotal safety study will be reported, which will be part of the company's US Food and Drug Administration (FDA) submission for the 780G, as well as a comparison of the 780G and 670G that is not related to the regulatory submissions, Medtronic spokesperson Pamela Reese told Medscape Medical News.
The 780G is expected to begin shipping later this year in select countries in Europe.
The company has not yet announced when the FDA submission will occur, Reese said.
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Cite this: Next-Generation 'Artificial Pancreas' System Gets EU Approval - Medscape - Jun 12, 2020.