Womble Bond Dickinson

[co-author: Heather Hatcher, Ph.D.]

Type I Diabetes is the most common type of diabetes in children, impacting about 1 in 400 children in the US according to the American Diabetes Association. Children diagnosed with Type 1 diabetes require lifelong daily injections of insulin to stay alive, which is challenging and stressful for the child and caregivers because fewer than 1 in 5 children with type 1 diabetes are able to successfully maintain a blood glucose in a healthy range with current treatment. Careful monitoring of insulin levels is essential for people with type 1 diabetes to reduce development of diabetic complications.

On August 31st, the U.S. Food and Drug Administration announced approval of Medtronic’s MiniMed770G System. The 770G System is a first-of-its-kind hybrid closed loop diabetes management device that automatically monitors blood glucose levels and provides appropriate doses of insulin with little to no input from users or their caregivers, and is intended for use by children aged two and older with Type 1 Diabetes. This is the first legally marketed device that can automatically monitor and adjust insulin doses based on glucose levels in this population.

The FDA first approved Medtronic’s MiniMed670G System, a nearly identical hybrid closed-loop system, for use in patients aged 14 and older in September 2016. The 670G System was expanded to include users 7 to 13 years and up in June 2018. The 770G System qualified for FDA Breakthrough Device status and expands the indications for use to include patients 2 years of age and up. The 770G System also includes Bluetooth communication capability. Both the 670G and 770G include a sensor that is attached to the body and measures glucose levels under the skin every five minutes. The Systems also include an insulin pump that is strapped to the body, as well as an infusion patch connected to the pump with a catheter that delivers insulin. The 770G System communicates data with Bluetooth devices, such as a smartphone, to help users view and monitor glucose levels and adjust doses at mealtimes if needed to prevent hyperglycemia. Following the results of a multicenter clinical trial conducted from June 2019 to March 2020, and funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the NIH, the system was found to be safe and effective at managing blood glucose levels in young children.

The FDA Breakthrough Device Program was launched in 2015 to facilitate the development and expedite the review of breakthrough technologies. It is a voluntary program for medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Congress established the program through section 515B of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360e-3, as created by section 3051 of the 21st Century Cures Act, Public Law 114–255, and amended by section 901 of the FDA Reauthorization Act of 2017, Public Law 115–52, the “Breakthrough Devices Program.” The Program is available for medical devices subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). The Program’s purpose is to get medical devices to patients that need them more quickly while also protecting and promoting public health. Priority review is granted to devices meeting the statutory criteria to qualify for the Program and post-market data collection, when scientifically appropriate, may be accepted in certain circumstances where the benefit-risk determination by FDA finds the time and cost of such data collection would adversely affect public health by significantly delaying the availability of medical devices that may improve the health of patients.

In the case of Medtronic’s MiniMed 770G System, it is easy to see why it would qualify for Breakthrough Device designation status as it is a first-of-a-kind device for patients in the 2 to 6 years of age population to automatically adjust insulin delivery based on continuous glucose monitor values.

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