New Artificial Pancreas OK'd for Tots with Type 1 Diabetes - MedPage Today

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Medtronic's hybrid closed loop MiniMed 770G system was approved for use in very young kids with type 1 diabetes, the FDA announced on Monday.

This approval marks the first hybrid closed loop system indicated for children ages 2 to 6 years old with type 1 diabetes.

The newly approved system is a Bluetooth-enabled version of its predecessor, Medtronic's MiniMed 670G, paired with a few new modifications. The MiniMed 670G, otherwise known as the first artificial pancreas, was the first fully automated insulin delivery device to win approval for type 1 diabetes and is currently indicated for patients as young as 7.

Neither system is indicated for patients with type 2 diabetes.

The MiniMed 770G includes a sensor attached to the skin that monitors glucose levels, along with an insulin pump strapped to the user's body, and an infusion patch connected to the pump with a catheter to deliver the insulin. The sensor measures glucose levels under the skin every five minutes and then automatically adjusts insulin delivery by either administering or withholding insulin. However, the user still must manually request a bolus insulin dose at mealtime to counteract carbohydrate intake.

The device is not approved for children younger than 2 nor for patients who need less than eight units of insulin per day.

Clinical trial data from 46 children ages 2 to 6 supported the approval. Participants wore the MiniMed 770G for three months through both an at-home and hotel observation periods. During the trial, no children experienced severe hypoglycemia, diabetic ketoacidosis, or other severe adverse events.

"Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition," FDA Commissioner Stephen Hahn, MD, said in a statement. "The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition -- which can particularly impact children -- is safe and effective."

However, the FDA also noted that continued approval is contingent on a post-marketing study to be completed by Medtronic, testing the system in a real-world setting. Certain potential risks that will be evaluated in this upcoming study include hypoglycemia, hyperglycemia, and possible skin irritation or redness surrounding the system's infusion patch.

Last Updated September 01, 2020

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  Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and dermatology news. Based out of the New York City office, she’s worked at the company for nearly five years.

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