Medtronic’s MiniMed 770G System has landed FDA clearance for its hybrid closed-loop system, marking the first time an automated insulin delivery system was greenlighted for young children with Type 1 diabetes.
This clearance means that the tool can be marketed to children as young as 2. It can also be used for adults. The system includes an algorithm which is able to measure a patient’s glucose levels every five minutes. Then, based on this measurement, the system can automatically adjust a patient’s insulin level either by giving them more insulin or withholding it. The system is made up of a sensor that attaches to the patient’s skin, an insulin pump, and an infusion patch.
Patients will be able to connect the system to a smartphone app, where patients and caregivers can access data about a patient’s insulin levels. The app will also alert users if a patient’s sugar levels are out of range.
Medtronic released research on the tool earlier this year at the American Diabetes Association’s 89th Scientific Sessions. In its data, the MiniMed 780G was trialed on 39 adolescents and 118 adults with Type 1 Diabetes. Participants used the system for two 45-day periods with different blood glucose target points. The study found that participants overall time in range was 75%.
According to an FDA release, the company also conducted clinical trials that included 46 children between 2 and 6 and found no serious adverse events. However, the agency will require Medtronic to conduct post-market research on children in that age range as well.
WHY IT MATTERS
Diabetes is a notoriously time-consuming condition to manage, and it can effect children as well as adults. According to the American Diabetes Association, approximately 210,000 Americans under 20 have the condition. Hybrid closed-loop systems have been pitched as a way to reduce the burden to patients and caregivers.
“Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition,” FDA Commissioner Dr. Stephen M. Hahn, said in a statement. “The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition – which can particularly impact children – is safe and effective.”
THE LARGER TREND
In 2016, Medtronic’s MiniMed 670G landed the first FDA clearance for a hybrid closed-loop system. However, that system was only designated for individuals over the age of 14.
Medtronic’s interest in the diabetes space isn’t limited to close loop systems. This summer, Medtronic announced its plans to buy Companion Medical, which is best known for making the InPen, an insulin pen that integrates a companion app, for an undisclosed sum.
It’s also shown interest in wellness products. In December, the company purchased Klue, a two-year-old startup that uses gesture-sensing and other behavioral health metrics to determine what someone is eating.