FDA OKs Hybrid Closed Loop Diabetes Management Device for Use in Young Children

Officials with the FDA have approved Medtronic’s MiniMed 770G system, a hybrid closed loop diabetes management device, for use by individuals aged 2 to 6 with type 1 diabetes, according to a press release.^1,2

The MiniMed 770G system, which is a bluetooth-enabled version of the previously approved MiniMed 670G system, is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the users or their caregivers. The device uses Medtronic’s SmartGuard technology, as featured in the MiniMed 670G system.^1,2

With this approval, the 770G System is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.¹

This latest system will allow caregivers and care partners to see user data remotely on their smartphones, with proactive in-app notices to provide alerts when sugar levels are out of range. This data can also be shared with clinicians and educators to facilitate more effective telehealth and product trainings.²

In a clinical trial including 46 children aged 2 to 6 years old with type 1 diabetes, study participants wore the device for approximately 3 months to evaluate the device’s performance during both at-home periods, as well as a hotel period, to stress the system with sustained daily exercise. According to the study, there were no serious advents, indicating that the device is safe for use.

Data from the study were used to help support the expanded indication for patients 2 to 6 years old, according to the FDA. Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. The FDA is requiring the device manufacturer to conduct a post-market study to evaluate device performance in real-world settings in children as young as 2 years old.¹

A clinical study of the MiniMed 670G system conducted in children 2 to 6 years of age demonstrated improvement in outcomes comparable to those observed in older adolescents and adults, according to Medtronic. In the study, A1C and Time in Range from 151 children were assessed alongside outcomes from 124 adolescents and adults over 2 weeks in Manual Mode and 3 months in SmartGuard Auto Mode.²

“When young children are diagnosed with diabetes, it is a family disease with parents and caregivers playing a substantial role in diabetes management,” Jennifer McVean, MD, pediatric endocrinologist with University of Minnesota Health, said in a statement.² “Being able to offer my patients an insulin pump system that provides safe, automated insulin delivery and smartphone connectivity is incredibly beneficial. I have seen favorable results with the MiniMed 670G system in my practice, and the younger age indication that the MiniMed 770G system offers can change the lives of even more people living with type 1 diabetes.”

The new MiniMed 770G system comes with the Guardian Sensor 3, the MiniMed mobile app, and Roche Accu-Chek Guide Link meter, which is Bluetooth compatible for improved usability.²

The device is not approved for use in children younger than 2 years old or in individuals who require less than 8 units of insulin per day.¹

References

1. FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients. News Release. FDA; August 31, 2020. Accessed September 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-automated-insulin-delivery-and-monitoring-system-use-young-pediatric.

2. Medtronic Announces FDA Approval for Minimed 770G Insulin Pump System with Smartphone Connectivity for People with Type 1 Diabetes. News Release. Medtronic; September 1, 2020. Accessed September 1, 2020. https://newsroom.medtronic.com/news-releases/news-release-details/medtronic-announces-fda-approval-minimedtm-770g-insulin-pump