The FDA has approved Medtronic’s 770G insulin pump, the newest hybrid closed loop system, for use in patients as young as 2 years old.
Parents of young children with Type 1 diabetes will undoubtedly cheer the announcement. This is now the lowest age indication by the FDA for any automated insulin pump on the market.
“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., a pediatric endocrinologist with University of Minnesota Health. “The younger age indication that the MiniMed 770G system offers can change the lives of even more people living with type 1 diabetes.”
The MiniMed 770G is a hybrid closed loop system, and requires some manual input. The pump constantly adjusts basal insulin rates based on continuous glucose monitor (CGM) readings; users still prompt boluses for meals or corrections. The 770G will run on the same “SmartGuard” algorithm that debuted with the currently available model, the Minimed 670G. SmartGuard aims to keep users at a blood sugar level near 120 mg/dL, with as much time in range as possible. A clinical study showed that 670G users between the ages of 2 and 7 enjoyed similar HbA1c and time-in-range improvements as did adolescents and adults.
The other major improvement that 770G will offer is Bluetooth connectivity. Users can choose to share data remotely with family members, caregivers and medical professionals, and to employ a remote warning system when the CGM picks up out-of-range blood sugars, another feature likely to be popular with parents and other caregivers of young children. The data sharing capability may also help facilitate doctor’s visits, especially as telemedicine check-ups become so much more common.
The Minimed 670G made a huge splash when it became the first hybrid closed-loop insulin pump available on the market. Many users remain fiercely loyal to the system, but there have been a few bumps in the road for Medtronic. Last year the company had to warn its customers of a potentially dangerous equipment malfunction, and research has showed that a high percentage of 670G users eventually ceased to use the auto mode function, chiefly because of technical difficulties. One of the researchers compared the device to a 90’s cellphone– a huge technological leap forward, but still one much in need of improvement. The SmartGuard algorithm has undergone various adjustments and refinements since its debut, and proponents will undoubtedly say that it’s better than ever. Further updates of the 770G system will be available via download as they are released.
The MiniMed 770G is not yet available on the Medtronic website, but a press release stated that the company would begin taking orders “this week.”
Still somewhere on the horizon is the next generation 780G system, referred to as an advanced hybrid closed loop system, which has significant additional functionality: it will deliver automatic correction boluses and will allow users to set a glucose target as low as 100 mg/dL. We’re extra excited about that last feature; the closer that a loop system can bring its user towards a truly healthy blood sugar level, the better. As of yet, the 780G is only intended for customers over the age of 6. At last report, the 780G would begin shipping to some European countries this autumn. No word on availability in North America.