The US Food and Drug Administration (FDA) has cleared a next-generation automated insulin delivery system, MiniMed Flex™, a compact, smartphone-controlled insulin pump designed for individuals aged ≥7 years with type 1 diabetes and adults with insulin-requiring type 2 diabetes, according to a March 18, 2026, company announcement.1
The MiniMed Flex is a next-generation automated insulin delivery (AID) system that is approximately half the size of the MiniMed™ 780G insulin pump, which received FDA clearance for adults with T2D in September 2025. It also offers a screenless, app-based interface and a 300-unit insulin reservoir. The pump integrates an adaptive algorithm that automatically adjusts and autocorrects insulin delivery in real time.1,2
Key Features of MiniMed Flex™ Insulin Pump
- Compact, discreet design with high insulin capacity
Approximately half the size of the previous MiniMed™ 780G system, with a 300-unit reservoir to support a wide range of insulin needs.
- Smartphone-controlled, screenless interface
Fully managed through a compatible mobile app, eliminating the need for a physical pump screen; supports remote control and software updates via iOS and Android devices.
- Adaptive automated insulin delivery (AID)
Powered by the SmartGuard™ algorithm with Meal Detection™ technology to automatically adjust and autocorrect insulin delivery in real time.
- Proven glycemic outcomes
Real-world data demonstrate approximately 80% time in range (70–180 mg/dL) using recommended settings.
- Sensor compatibility
Designed to integrate with newer continuous glucose monitoring systems, including Simplera Sync™ and Abbott-developed sensors at launch.
- Extended infusion set options
Compatible with infusion sets designed for up to 7 days of wear, reducing injection frequency compared with traditional insulin therapy.
- Flexible wearability
Can be worn discreetly (eg, in a pocket or under clothing), supporting patient preference and lifestyle integration.
- Broad indication
Cleared for patients aged ≥7 years with type 1 diabetes and adults with insulin-requiring type 2 diabetes.
- Seamless upgrade pathway
Transition program available for current MiniMed™ 780G users, facilitating continuity of care and device adoption.
"MiniMed Flex™ represents an important leap forward for MiniMed," Anders Carlson, MD, medical director, International Diabetes Center at Park Nicollet, director, HealthPartners Diabetes Program, assistant professor, University of Minnesota Medical School, said in a press release.1 "For many people living with diabetes, the burden of daily management can be overwhelming. By combining a discreet, screenless form factor with a powerful adaptive algorithm that responds quickly to changes in glucose, MiniMed Flex™ brings meaningful innovation exactly where it's needed—into the flow of everyday life. This level of automation, paired with the freedom of smartphone control, has the potential to improve consistency, confidence, and ultimately clinical outcomes for a broad range of patients with diabetes."
MiniMed Flex incorporates the company’s SmartGuard™ algorithm with Meal Detection™ technology and has demonstrated approximately 80% time in range (70–180 mg/dL) in real-world data using recommended settings.3 The system is designed to reduce patient burden by automating insulin delivery and enabling remote control via compatible iOS and Android devices.1
At launch, the device will be compatible with newer continuous glucose monitoring sensors, including Simplera Sync™ and another sensor developed in partnership with Abbott. It also supports extended infusion set use for up to 7 days, which may reduce injection frequency compared with traditional insulin regimens.1
MiniMed also announced a transition program allowing eligible users of its prior system to upgrade to the new platform. A limited rollout is expected in spring 2026, followed by broader US availability in summer 2026.1
References:
- MiniMed Announces FDA Clearance of MiniMed Flex™, the Company's Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design. News release. MiniMed. March 18, 2026. Accessed March 18, 2026. https://www.prnewswire.com/news-releases/minimed-announces-fda-clearance-of-minimed-flex-the-companys-smallest-insulin-pump-featuring-its-first-smartphone-controlled-design-302716864.html
- Jennings S. FDA Approves Automated Insulin Delivery System for Adults With Type 2 Diabetes. Patient Care Online. September 13, 2025. Accessed March 18, 2026. https://www.patientcareonline.com/view/fda-approves-automated-insulin-delivery-system-for-adults-with-type-2-diabetes
- Nally LM, et al.; SUCCEED Study Group. Safety and Glycemic Outcomes of the MiniMed 780G System with a Disposable All-in-One Sensor. Diabetes Technol Ther. 2026 Feb;28(2):109-120. doi:10.1177/15209156251368928
