This week, the Food and Drug Administration (FDA) approved the Medtronic MiniMed 770G artificial pancreas system for use by children aged 2 to 6 with type 1 diabetes (T1D). The 770G System is now approved for ages 2 and older and is the first marketed device that can automatically adjust insulin delivery based on continuous glucose monitoring (CGM) values for children aged 2-6 years.
The MiniMed 770G is a Bluetooth-enabled version of the previously approved MiniMed 670G System, which will enable sharing of data on smart devices. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime. (This device is not approved for use in children younger than 2 years old and in individuals who require less than eight units of insulin per day.)
The FDA evaluated data from a clinical trial that included 46 children aged 2 to 6 years old with T1D. The study found no serious adverse events, and data from the study was used to help support the expanded indication for people 2 to 6 years old.
Breakthrough T1D Impact
Breakthrough T1D has been a leader in the development of artificial pancreas systems for 15 years, since starting the Breakthrough T1D Artificial Pancreas Project in 2005 and the Breakthrough T1D Artificial Pancreas Consortium, which have dramatically accelerated progress by bringing academic researchers, government agencies, industry and the Helmsley Charitable Trust together to pursue artificial pancreas technology.
Through these efforts, Breakthrough T1D developed a roadmap for artificial pancreas development with increasingly advanced versions of the device. Manufacturers embraced the roadmap to guide their own research and development programs. Breakthrough T1D has also worked with Congressional leadership—particularly Senate Diabetes Caucus Co-Chairs Susan Collins of Maine and Jeanne Shaheen of New Hampshire and Congressional Diabetes Caucus Co-Chairs Diana DeGette of Colorado and Tom Reed of New York—to secure Federal funding through the Special Diabetes Program (SDP) for artificial pancreas research and overcome obstacles that could delay delivery of artificial pancreas systems to people with T1D.
- Breakthrough T1D has funded over $135 million to date in artificial pancreas research.
- As testing new artificial pancreas technology in people with T1D can be challenging, Breakthrough T1D partnered with the FDA on the regulatory pathway for testing and approval of this technology, leading to the 2012 FDA guidance for artificial pancreas systems. Industry experts have said Breakthrough T1D’s involvement cut five years off the approval process for the Medtronic 670G artificial pancreas system in 2016, the first approved system.
The Special Diabetes Program (SDP) is up for renewal, so if you haven’t done so already, please sign-up to be an advocate, and encourage friends and family to do the same.
- Breakthrough T1D has also been a leading advocate for coverage, affordability and choice for diabetes technology and the insulin people need through our Coverage2Control Campaign. In a victory for the C2C Campaign—driven by our powerful network of advocates—the nation’s largest insurer, United Healthcare, announced that they will expand their insulin pump coverage. People with T1D now have more choice in how they manage their diabetes, and we applaud United Healthcare for this change.
This is the latest example of how Breakthrough T1D research and advocacy work together to make T1D management better and safer. This is a win for the T1D community, and provides people at a young age with T1D another option to improve daily blood-sugar management, until cures are found.
Read more about how we’re turning Type One into Type None.
