Medtronic Diabetes Advances Insulin Delivery Access and Regulatory Approvals

Medtronic (NYSE: MDT), a global leader in medical technology, today announced a series of landmark U.S. milestones designed to broaden access, choice and flexibility for people living with diabetes — including both type 1 and insulin-requiring type 2 diabetes. This news reflects an expanded effort to make advanced automated insulin delivery technology more accessible through Medicare coverage and new U.S. Food and Drug Administration (FDA) clearances.

Expanding Medicare Access for the MiniMed 780G System with Instinct Sensor

One of the key developments is that Medicare and Medicare Advantage beneficiaries in the United States can now access the MiniMed™ 780G system paired with the Instinct sensor, a continuous glucose monitoring (CGM) sensor made by Abbott that is slim, discreet to wear, and provides up to 15 days of use.

Prior to this change, Medicare beneficiaries had more limited access to some automated insulin delivery options. With this update, eligible individuals now have greater sensor choice, as Medicare coverage already included access to other available compatible sensors such as the Simplera Sync™ and Guardian™ 4 sensors. Enhanced sensor availability increases flexibility for users managing daily glucose monitoring and insulin adjustments. Automated insulin delivery systems like the MiniMed 780G can reduce daily burden by making insulin adjustments every five minutes based on real-time glucose readings, striving to maintain stable glucose levels with fewer manual decisions required.

Medicare beneficiaries who previously placed orders for the MiniMed 780G system with the Instinct sensor will now move forward through the standard Medicare billing and fulfillment process, depending on individual eligibility and insurance requirements. Medtronic Diabetes is also working closely with distributor partners to support readiness and timely shipment for eligible customers.

FDA Clearance for Ultra Rapid-Acting Insulins

In addition to expanded Medicare access, the FDA has cleared the MiniMed 780G system for use with ultra rapid-acting insulins such as Fiasp and Lyumjev. This new clearance gives people living with diabetes more flexibility and personalization options in their insulin therapy.

Ultra rapid-acting insulins are designed to more closely mimic the body’s natural insulin response around mealtimes, with a faster onset of action compared to traditional rapid-acting insulins. In practical terms, this may help individuals better manage post-meal glucose spikes, especially in situations where pre-meal insulin dosing is late or missed. When paired with the MiniMed 780G system’s Meal Detection™ technology, these insulin options can help alleviate some of the pressure of precise carbohydrate counting and timing insulin doses accurately when eating.

These clearances support clinicians and individuals in choosing the insulin type that best matches their physiology and lifestyle, allowing more personalized therapy and the potential for improved overall glucose outcomes for users of the system.

FDA Clearance for Type 2 Diabetes Use with Instinct Sensor

The FDA has also cleared the MiniMed 780G system for use with the Instinct sensor for people living with insulin-requiring type 2 diabetes. This means that adults with type 2 diabetes who require insulin therapy now have access to the same advanced automated insulin delivery technology previously available mostly to people living with type 1 diabetes.

To achieve this, the FDA cleared the MiniMed 780G’s SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC) and designated the pump itself as an alternate controller enabled (ACE) device when used with the Instinct sensor. The SmartGuard algorithm automatically adjusts insulin delivery every five minutes based on real-time glucose data, helping keep glucose levels in a target range more consistently by reducing both highs and lows.

For people living with insulin-requiring type 2 diabetes, managing daily injections, meal planning, glucose monitoring, and insulin dosing can be physically and emotionally demanding. Automated systems like MiniMed 780G aim to ease some of that daily burden by taking over many of the routine decisions involved in insulin management.

Once again, users of the system for type 2 diabetes will have sensor options, including the Instinct, Guardian 4, and Simplera Sync sensors, offering flexibility in choosing the CGM that best suits their needs.

Benefits of Automated Insulin Delivery Technologies

Automated insulin delivery (AID) systems like the MiniMed 780G combine an insulin pump and CGM sensor with intelligent algorithms that adjust insulin delivery frequently throughout the day. These systems are sometimes referred to as “hybrid closed-loop” or “full-stack” insulin delivery solutions because they integrate real-time glucose data, automated insulin dosing, and adaptive control algorithms.

For many people living with diabetes, AID systems can:

• Reduce the number of manual insulin adjustments required daily;
• Help maintain glucose levels within a recommended range by automatically raising or lowering insulin delivery;
• Ease the mental and emotional burden of continual glucose monitoring and dosing decisions;
• Potentially reduce the frequency of both high and low glucose episodes, contributing to better overall glucose control.

Because these systems operate on real-time glucose data and adjust insulin every few minutes, many users experience greater confidence in managing day-to-day glucose changes and insulin needs. The addition of new insulin options and updated regulatory clearances continues to broaden the potential user base for these technologies and reflects ongoing progress toward more personalized and effective diabetes care.

Medtronic Diabetes Mission and Innovation

Medtronic Diabetes has been at the forefront of developing diabetes technology for decades and is committed to designing solutions that make diabetes more predictable and manageable. Beyond insulin delivery systems, the company focuses on next-generation continuous glucose monitoring (CGM) sensors, intelligent dosing systems, and data-driven tools that support users in their daily diabetes journeys.

These recent Medicare and FDA milestones demonstrate Medtronic’s continued dedication to expanding access to advanced diabetes technologies, helping people of different ages and with different types of diabetes access tools that support healthier and more flexible lifestyles.

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