The FDA has approved the latest automated artificial pancreas system from Medtronic, the MiniMed 770G, for adults and children with Type 1 diabetes as young as 2 years old.
This makes the hybrid, closed-loop device—designed to adjust background insulin doses in response to frequent sensor readings, with little effort needed from the wearer—the first insulin pump of its kind to be available for children between the ages of 2 and 6, the agency said.
Typically the blood sugar levels of people with Type 1 diabetes must be consistently measured and regulated with insulin injections via a syringe, pen or manually operated pump.
The 770G is an upgraded, Bluetooth-enabled version of Medtronic’s previously approved MiniMed 670G—allowing a user, parent or caregiver to operate the device and trigger additional insulin doses during meals via a smartphone.
The system includes a glucose sensor that takes readings every five minutes, a wearable pump and an infusion patch. The device has not been approved for users who require fewer than eight units of insulin per day.
Additionally, the smartphone makes it easier to track and share real-time blood sugar readings and dosing data with clinicians, including through telemedicine consultations, and provide alerts when the wearer’s glucose levels stray outside of a healthy range.
"We’re thrilled to be launching this new system as we understand how important these data sharing features are, particularly right now—with many individuals and families opting to see their doctors virtually via telehealth visits," said Sean Salmon, president of Medtronic’s diabetes group.
"As a parent, I understand very personally why connectivity is so important and I’m pleased we’ll be able to broaden access to hybrid closed loop therapy with the additional peace of mind caregivers need to ensure the well-being of their loved ones,” Salmon added.
The FDA approved the system using data from a clinical trial that included 46 children between the ages of 2 and 6, who wore the device for about three months both at home and under observation in a hotel. They saw improvements in glucose control similar to older adolescents and adults, with no episodes of severely low blood sugar or diabetic ketoacidosis.
Medtronic said it will be taking U.S. orders for the 770G starting this week.