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FDA OKs Automated Insulin Delivery and Monitoring System for Use in Younger Children
The FDA has expanded the approval of the MiniMed 670G hybrid closed-looped system (Medtronic), a diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user, to include patients 7–13 years of age with type-1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type-1 diabetes.
The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired. Because the pancreas does not make insulin in people with type-1 diabetes, patients must consistently monitor their glucose levels throughout the day and inject insulin with a syringe, pen, or pump to avoid becoming hyperglycemic. In addition, management of type-1 diabetes includes following a healthy eating plan and physical activity. Type-1 diabetes, also known as juvenile diabetes, is typically diagnosed in children and young adults.
The MiniMed 670G hybrid closed-looped system works by measuring glucose levels in the body every five 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 7–11 years of age. Study participants wore the device for approximately 3.5 months and participated in three phases of the study to evaluate both at-home use as well as 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 7 to 13 years of age 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. As part of this approval, the FDA is requiring the product developer to conduct a post-marketing study to evaluate device performance in real-world settings in children between 7 and 13 years of age. This device is not approved for use in children 6 years of age or younger and in individuals who require less than eight units of insulin per day.
Source: FDA; June 21, 2018.