The US Food and Drug Administration (FDA) has approved the MiniMed 770G (Medtronic) automated insulin delivery system for children aged 2 to 6 years.
The 770G system adds Bluetooth smartphone connectivity to the SmartGuard technology that is present in the hybrid closed-loop MiniMed 670G system, which has been available in the United States since 2016 for individuals aged 14 years and older who have type 1 diabetes. It has been available since 2018 for children aged 7 years.
The 770G will also be available to older children and adults once it has been launched.
As with other so-called artificial pancreas systems, the 770G comprises an insulin pump and continuous glucose monitor that are connected via software that allows the pump to deliver or withhold insulin on the basis of glucose readings.
It is a “hybrid closed-loop” system in that users or caregivers must still manually signal carbohydrate consumption.
The 770G includes a “share” feature that allows healthcare providers, users, and caregivers to follow the user’s glucose levels remotely via smartphones. In-app notices indicate when glucose levels are out of range. The data can be uploaded prior to telehealth visits.
The approval was based on a 3-month study of 151 children aged 2 to 6 years who showed improvement in outcomes comparable to those seen in 124 older adolescents and adults with the 770G system as compared to patients who used manual (non-looped) mode over a 2-week period. There were no episodes of severe hypoglycemia or diabetic ketoacidosis and no serious device-related adverse events while in hybrid closed-loop mode.
The FDA will require Medtronic to conduct a postmarketing study to evaluate the 770G in real-world settings. It is not approved for use in children younger than 2 years nor in any patient who requires less than 8 units of insulin per day.
The next-generation Medtronic closed-loop system, the 780G, has already been approved in Europe. It improves on the technology by delivering automated bolus correction doses in addition to basal insulin every 5 minutes. The company is preparing to submit the 780G for approval in the United States.