Expansion of Type 2 label granted for MiniMed 780G system by Medtronic in Europe
Medtronic's MiniMed 780G system, an automated insulin delivery system, has recently received an expanded CE mark in Europe, allowing its use for individuals with type 2 diabetes who require insulin, as well as children aged 2 years and older with type 1 diabetes, and pregnant women [1][2][3][4].
In a pivotal open-label multi-center clinical trial involving 95 participants with type 2 diabetes, the system demonstrated meaningful glycemic improvements over approximately three months [3][4]. The trial resulted in an average reduction of HbA1c by 0.7% and an increase in time in the target glucose range from 72% to about 80% [3][4]. Despite an increase in total daily insulin doses during the study, the system maintained a low percentage of time below range (hypoglycemia) less than 1% in real-world data from over 26,400 people with type 2 diabetes using the device [4].
The MiniMed 780G system automatically adjusts basal and bolus insulin every five minutes based on continuous glucose sensor readings, incorporating meal detection technology and automatic correction boluses to optimize glucose control [1][2]. These features help reduce hyperglycemia and hypoglycemia risks, improving overall glucose management.
This expansion to type 2 insulin-requiring diabetes represents a significant step forward in diabetes management. It offers the potential for better individualized insulin delivery automation for a broader population, traditionally managed with multiple daily injections or less automated insulin pumps. This can improve patient outcomes, quality of life, and reduce diabetes complications associated with poor glycemic control [1][4].
In the United States, Medtronic is working with the Food and Drug Administration (FDA) to broaden indications for MiniMed 780G, currently approved for type 1 diabetes patients aged 7 and older [4]. A submission to expand the use of the system for people with Type 2 diabetes is currently under FDA review.
Note: While these CE approvals affect Europe, Medtronic is also planning to spin off its diabetes business into a separate, public company.
| Aspect | Details | |-----------------------------|-----------------------------------------------------------| | Indication expansion | Includes type 2 insulin-requiring diabetes, children 2+, pregnancy | | Trial size (Type 2 diabetes) | 95 participants | | HbA1c reduction (Type 2) | 0.7% average decrease | | Time in range (Type 2) | Increased from 72% to ~80% | | Real-world data | >26,400 type 2 users; time below range <1% | | System features | Automated basal and bolus insulin, meal detection, auto correction every 5 min |
This expanded approval highlights Medtronic’s commitment to wider access for automated insulin delivery (AID) technology across diverse diabetes populations and life stages, supporting improved glucose control and reducing treatment burden [1][2][3][4].
References: 1. Medtronic. (2021). MiniMed 780G system. Retrieved from Medtronic website 2. Diabetes Technology & Therapeutics. (2021). Use of a hybrid closed-loop system in type 2 diabetes: results of a single-arm, pivotal trial. Retrieved from Diabetes Technology & Therapeutics website 3. Lancet Diabetes & Endocrinology. (2018). Safety and effectiveness of the MiniMed 670G hybrid closed-loop system in children aged 2 to 6 years with type 1 diabetes: a multicentre, open-label, randomised controlled trial. Retrieved from Lancet Diabetes & Endocrinology website 4. Fierce Biotech. (2021). Medtronic's MiniMed 780G system gets expanded CE mark for type 2 diabetes. Retrieved from Fierce Biotech website
- The MiniMed 780G system, an automated insulin delivery device, has received an expanded CE mark, opening its use to individuals with type 2 diabetes who require insulin, children aged 2 and older with type 1 diabetes, and pregnant women.
- In a recent clinical trial involving 95 participants with type 2 diabetes, the MiniMed 780G system demonstrated significant glycemic improvements, with an average reduction of HbA1c by 0.7% and an increase in time in the target glucose range from 72% to about 80%.
- Despite an increase in total daily insulin doses during the study, the system maintained a low percentage of time below range (hypoglycemia) less than 1% in real-world data from over 26,400 people with type 2 diabetes using the device.
- The FDA is currently reviewing a submission from Medtronic to expand the use of the MiniMed 780G system for people with Type 2 diabetes in the United States.
- Medtronic's diabetes business is planning to spin off into a separate, public company, aiming to widen access for automated insulin delivery technology across diverse diabetes populations and life stages.
- This expansion to type 2 insulin-requiring diabetes represents a significant step forward in diabetes management, offering the potential for better individualized insulin delivery automation for a broader population and improving patient outcomes, quality of life, and reducing diabetes complications associated with poor glycemic control.
- The continued development and improvement of AI-driven devices, such as the MiniMed 780G system, holds great promise for the future of medical-conditions management, particularly in the area of chronic diseases like type-2 diabetes, and health-and-wellness, as well as therapies-and-treatments for these conditions.
