Officials with the FDA have expanded the approval of Medtronic’s MiniMed 670G hybrid closed looped system to include individuals aged 7 to 13 with Type 1 diabetes.
Officials with the FDA have expanded the approval of Medtronic’s MiniMed 670G hybrid closed looped system to include individuals aged 7 to 13 with Type 1 diabetes. The FDA originally approved this diabetes management device, which is intended to automatically monitor glucose, and to provide appropriate basal insulin doses with little or no input from the user, in September 2017 for use in patients 14 years of age and older with Type 1 diabetes.
In a statement, FDA Commissioner Scott Gottlieb, MD, said management of Type 1 diabetes can be stressful for patients and their caregivers, and especially when the patients are young children. “Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives. Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children,” said Gottlieb, in a statement. “Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks”
The MiniMed 670G hybrid closed looped system works by measuring glucose levels in the body every 5 minutes, and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime.
The FDA evaluated data from a clinical trial of the MiniMed 670G hybrid closed looped system that included 105 individuals aged 7 to 11 years old. Study participants wore the device for approximately 3.5 months, and participated in 3 phases of the study to evaluate at-home use, and remote use. That study found no serious adverse events associated with use of the MiniMed 670G, and that the device is safe for use in people age 7 to 13 years with Type 1 diabetes.
Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. The FDA is requiring the product developer to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of 7 and 13, as part of its new approval. This device is not approved for use in children 6 years of age or younger and in individuals who require less than 8 units of insulin per day.
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients [news release]. Silver Spring, MD: June 21, 2018; FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611475.htm. Accessed June 21, 2018,