The Food and Drug Administration (FDA) has approved the Medtronic MiniMed™ 780G system with the Guardian™ 4 sensor for patients 7 years of age and older with type 1 diabetes.
In addition to continuous glucose monitoring (CGM), the advanced hybrid closed-loop (AHCL) system continuously delivers basal insulin at selectable rates and issues correction insulin boluses without user input. Using the Company’s SmartGuard™ technology, the MiniMed 780G system can be programmed to adjust insulin delivery based on CGM sensor glucose values and features a default glucose target setting of 100mg/dL (with the option of 120mg/dL).
“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,” said Que Dallara, EVP and President of Medtronic Diabetes. “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.”
The approval was based on data from a single-arm study (ClinicalTrials.gov Identifier: NCT03959423) that included 157 adult and adolescent participants (14 to 75 years old) with type 1 diabetes. Results showed use of the AHCL system led to a reduction in HbA1C and increased overall time in range (defined as 70 to 180mg/dL) compared with a run-in period that included sensor-augmented pump with or without predictive low glucose management or automated basal insulin delivery use.
The overall time in range and overnight time in range were reported to be 75% and 82%, respectively, among MiniMed 780G users. The time in range increased to 76% when the target was adjusted to 100mg/dL and active insulin time set to 2 to 3 hours, and further increased to 79% when active insulin time was set to 2 hours. As for safety, no severe hypoglycemic or diabetic ketoacidosis events occurred during the study.
The first shipments of the MiniMed 780G system are expected this summer with preorders beginning on May 15, 2023. According to Medtronic, individuals using the MiniMed™ 770G will be eligible to upgrade their device to the MiniMed 780G remotely at no cost.
- FDA approves Medtronic MiniMed™ 780G System – world’s first insulin pump with meal detection technology* featuring 5-minute auto corrections†§. News release. Medtronic. April 21, 2023. https://www.prnewswire.com/news-releases/fda-approves-medtronic-minimed-780g-system—worlds-first-insulin-pump-with-meal-detection-technology-featuring-5-minute-auto-corrections-301804565.html.
- Carlson AL, Sherr JL, Shulman DI, et al. Safety and glycemic outcomes during the MiniMed ™ advanced hybrid closed-loop system pivotal trial in adolescents and adults with type 1 diabetes. Diabetes Technology & Therapeutics. Published online March 14, 2022. doi.org/10.1089/dia.2021.0319