FDA approves Medtronic meal detection insulin pump system for type 1 diabetes

FDA approval | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved Medtronic’s MiniMed 780G system with Guardian 4 sensor, requiring no finger sticks while in SmartGuard technology, for children and adults with type 1 diabetes (T1D) aged 7 years and up, according to a Medtronic press release.¹

The April 21, 2023, FDA approval of MiniMed 780G makes it the only system with meal detection technology that provides automatic adjustments and corrections to sugar levels every 5 minutes for basal and bolus insulin requirements. The system provides insulin to help account for when users forget to bolus or underestimate the number of carbs in their meal.¹

The FDA states the system is intended for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for management of T1D for people requiring insulin. SmartGuard technology can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring values (CGM). Delivery of insulin can be suspended when the SmartGuard value falls below or is predicted to fall below predefined threshold values.²

The system, which has been available in Europe since 2020, features the lowest glucose target setting in any automated insulin pump on the market, according to Medtronic (as low as 100 mg/dL).¹ In this low-glucose setting, the pump will automatically deliver basal insulin adjustments and autocorrections to a set target.¹ According to the FDA, the MiniMed 780G system includes the new Advanced Hybrid Closed Loop algorithm as a part of its SmartGuard technology.² This can issue automatic correction insulin boluses without input from the user and compared to a single glucose target in MiniMed 670G/770G systems, the 780G system offers multiple glucose targets.²

The pivotal US trial of the system demonstrated that users experienced 75% time in range of blood sugar between 70 and 180 mg/dL, with overall time below range of 1.8%. Overnight, the system provided a time of range of 82% and an overnight time below range of 1.5%. Time of range reached 78.8% without increasing hypoglycemia while using the lower target of 100 mg/dL and an active insulin time set to 2 hours.¹

The ADAPT study, a randomized controlled study evaluating the performance of the 780G system compared to multiple daily injections used in conjunction with an intermittently scanned CGM (isCGM), reinforced benefits of the automated therapy. Six-month results demonstrated a 27.6% increase in time in range and a 1.4% reduction in HbA_1C compared to those using multiple daily injections and isCGM.

Medtronic will begin taking pre-orders for the MiniMed 780G system on May 15, 2023, with first shipments expected in the summer.¹

References:

1. FDA approves Medtronic MiniMed 780g system - world’s first insulin pump with meal detection technology featuring 5-minute auto corrections. Medtronic News. April 21, 2023. Accessed April 24, 2023. https://news.medtronic.com/2023-04-21-FDA-Approves-Medtronic-MiniMed-TM-780G-System-Worlds-First-Insulin-Pump-with-Meal-Detection-Technology-Featuring-5-Minute-Auto-Corrections

2. FDA Roundup: April 21, 2023. FDA. April 21, 2023. Accessed April 24, 2023. https://www.fda.gov/news-events/press-announcements/fda-roundup-april-21-2023