FDA approves next-generation advanced hybrid closed-loop insulin delivery system
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Key takeaways:
- The FDA approved the Medtronic MiniMed 780G system for people with type 1 diabetes aged 7 years and older.
- The advanced hybrid-closed loop system automatically adjusts basal and bolus insulin every 5 minutes.
The FDA approved an advanced hybrid-closed loop insulin pump that provides automated real-time insulin corrections for the user, according to a press release.
The Medtronic MiniMed 780G system was approved for use with the Guardian 4 sensor for children and adults aged 7 years and older with type 1 diabetes. The newly-approved system uses meal detection technology to automatically adjust basal and bolus insulin needs every 5 minutes. The system provides insulin to help account for when users occasionally forget to bolus or underestimate the number of carbohydrates in their meal. The MiniMed 780G requires no finger sticks while using the system’s SmartGuard technology.
"Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections," Que Dallara, executive vice president of Medtronic and president of Medtronic Diabetes, said in a press release. "A lot can happen to blood sugars in the span of an hour or even just a few minutes, so we've designed our system for real life — the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes. We built in features informed by extensive customer feedback, and we're excited to deliver a system with ease of use at the forefront."
In findings from a trial conducted in the U.S., participants using the MiniMed 780G system at home for 90 days had a time in range of 75% and a time below range of 1.8%. During overnight hours, time in range increased to 82% and overnight time below range dropped to 1.5%. The results are similar to real-world data observed in Europe, where the system was approved for use in 2020.
In findings from the Advanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes (ADAPT) randomized controlled trial conducted in Europe, 82 participants with type 1 diabetes were randomly assigned, 1:1, to use the MiniMed 780G or multiple daily injections with an intermittently scanned continuous glucose monitor. At 6 months, participants using the MiniMed 780G had a 27.6% greater increase in time in range and 1.4% greater reduction in HbA1c compared with the group using multiple daily injections. At 6 months, all participants crossed over to use the MiniMed 780G. At 1 year, similar improvements in time in range and HbA1c were observed for crossover participants.
Medtronic will begin to take pre-orders for the MiniMed 780G in the U.S. on May 15, 2023, with the first shipments planned for the summer, according to the release.
Reference:
Choudhary P, et al. Lancet Diabetes Endocrinol. 2022;doi:10.1016/S2213-8587(22)00212-1.
Perspective
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
I am so excited about the long-awaited Medtronic 780G FDA approval. Back in 2017, I had tons of patients start the Medtronic 670G as this was the first FDA approved automated insulin delivery system. It was revolutionary at the time, but as patients gained experience with it, we saw areas for improvement. Fortunately, the landscape expanded at the end of 2019 when Tandem’s Control IQ became available — the first FDA-approved automated insulin delivery system that did not require calibrations. Then in 2022, Omnipod 5 became the first automated insulin delivery system without tubing or required calibrations.
Medtronic, the long-time market leader in insulin pumps, was starting to fall behind in the U.S. Meanwhile, outside the U.S., the 780G became available in 2020 and people loved it. We were waiting patiently for approval here, which was starting to feel like it would never come and then on April 21, 2023, we heard the news.
Why am I so excited? I love being able to offer patients more choices. Medtronic has a 7-day infusion set option, which means fewer site changes. It runs off batteries instead of a charging cable, so one less thing to remember to charge. The Guardian 4 continuous glucose monitor requires no calibrations, a huge improvement from the two to four recommended for optimal use with the 670G and 770G. The most exciting improvement is the target, now as low as 100 mg/dL, and also autocorrections up to every 5 minutes to increase time in range. The clinical trial data along with the real-world experiences of people from other countries are very impressive. Thanks to the Bluetooth connectivity, people using the Medtronic 770G will be able to upgrade easily to the 780G via a software update.
I can’t believe how far the diabetes technology space has come over the last several years and look forward to all the innovation to come.
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