What You Should Know:
– Medtronic announced the U.S. Food and Drug Administration (FDA) approval of the MiniMed™ 770G hybrid insulin pump system with smartphone connectivity and an expanded age indication to patients with Type 1 diabetes aged 2 and up ― the lowest age indication by the FDA for an automated insulin pump system.
– The new MiniMed 770G system comes with the Guardian™ Sensor 34, the MiniMed™ Mobile app (compatible with both iPhone and Android), and Roche Accu-Chek® Guide Link meter, which is Bluetooth® compatible for improved usability.
Medtronic announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 770G hybrid closed-loop system. This newest insulin pump system offers the company’s most advanced SmartGuard™ technology, as featured in the MiniMed™ 670G system, with the added benefits of smartphone connectivity and an expanded age indication to children as young as 2.
This latest system by Medtronic expands the benefits of hybrid closed-loop therapy to younger children living with type 1 diabetes and makes it easier to access and share real-time CGM and pump data. The system will enable caregivers and care partners to see user data remotely on their smartphones, with proactive in-app notices sent when sugar levels are out of range. The data can also be shared automatically with clinicians and educators to help facilitate more effective telehealth visits and product training. This connectivity also gives Medtronic the ability to provide upgrades to future technology via software updates which can further enhance security and device features.
Why It Matters
Approximately 1.25 million Americans live with type 1 diabetes, with diagnoses as young as infancy. Caring for a child is difficult work, but caregivers face unique challenges when monitoring the health of a child with diabetes. The growing body of clinical evidence on hybrid closed-loop therapy demonstrates both the safety of the technology and improved clinical outcomes across adults, adolescents, and younger children. A clinical study of the MiniMed 670G system conducted in children two to six years of age showed an improvement in outcomes comparable to those observed in older adolescents and adults and supported the submission of the MiniMed 770G system.
In the study, A1C and Time in Range from 151 children were assessed alongside outcomes from 124 adolescents and adults over two weeks in Manual Mode and three months in SmartGuard Auto Mode (hybrid closed loop algorithm). There were no episodes of severe hypoglycemia or diabetic ketoacidosis, and no serious device-related adverse events while in SmartGuard Auto Mode.
“When young children are diagnosed with diabetes it is a family disease with parents and caregivers playing a substantial role in diabetes management,” said Jennifer McVean, M.D., pediatric endocrinologist with University of Minnesota Health. “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.”
Key Features
The algorithm that powers the insulin pump, known as SmartGuard Auto Mode, refers to the system’s ability to continually adjust the amount of insulin delivered every five minutes, 24 hours a day, based on the needs of the individual. The goal of this automated delivery of background insulin is to maximize the time glucose levels are within the optimal target range and to minimize both high and low glucose levels. The new MiniMed 770G system comes with the Guardian™ Sensor 34, the MiniMed™ Mobile app (compatible with both iPhone and Android), and Roche Accu-Chek® Guide Link meter, which is Bluetooth® compatible for improved usability.
Users of the MiniMed 770G system will now have access to an elevated level of care, including:
– Ability to display both their pump and continuous glucose monitor (CGM) information on the system user’s personal smartphone using the MiniMed™ Mobile app
– Ability to provide care partners remote access to patients’ pump and CGM data via the CareLink™ Connect app, enabling peace-of-mind for caregivers, convenience and confidence for parents, and the opportunity for kids to build independence
– Ability for data to be shared automatically with clinicians and educators to help facilitate more effective telehealth visits and product trainings during the COVID pandemic
Availability
Medtronic will begin taking orders for the new MiniMed 770G system in the United States this week.
