September 1, 2020

The U.S. FDA has approved the MiniMed™ 770G hybrid closed loop insulin pump system, manufactured by Medtronic. According to the FDA, “it is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values” for patients 2-6 years of age who have type 1 diabetes.

Patients who have type 1 diabetes require careful blood glucose monitoring accompanied by appropriate use of insulin to prevent potentially dangerous hyperglycemic (high glucose levels) or hypoglycemic (low glucose levels). The MiniMed 770G measures blood glucose levels every five minutes and automatically adjusts insulin delivery accordingly. It can also be linked to a smartphone using Bluetooth technology, allowing easy access to blood glucose management data for patients, caregivers, and healthcare providers through a mobile app. The app also sends proactive alerts when blood glucose levels are outside of a desired range.

The MiniMed 770G consists of a sensor placed beneath the skin for continuous glucose monitoring; an insulin pump that is worn strapped to the body; and an infusion patch and catheter that deliver insulin from the pump to the patient. A clinical study found that there were no serious adverse events and that the device is safe for use in children 2-6 years of age.

Although the device adjusts insulin delivery based on glucose monitoring, patients or their caregivers must manually request insulin doses to counter carbohydrate consumption at mealtime. It should not be used in patients who require less than eight units of insulin per day. There is a risk of hypoglycemia and hyperglycemia with insulin pumps, as well as skin irritation or redness around the infusion patch.

The FDA is requiring Medtronic to conduct a post-market study to evaluate device performance in real-world settings in children ages 2-6.

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