Automated Insulin Delivery System Aids Pediatric Patients

The system is powered by the SmartGuard HCL algorithm, which uses real-time data gathered from an advanced glucose sensor. While the device automatically adjusts insulin levels, users still need to manually enter meal carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor.

The system includes the Contour Next Link 2.4 blood glucose monitoring system (BGMS) from Ascensia (Parsippany, NJ, USA), which attaches to the body to measure interstitial fluid glucose levels under the skin; the insulin pump itself, which is strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. The MiniMed 670G has been approved for individuals aged seven and up, but is not approved for use in children six years of age or younger and in individuals who require less than eight units of insulin per day.

“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people's lives,” said FDA Commissioner Scott Gottlieb, MD, commenting on device approval. “Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children.”

Type 1 diabetes (T1D) is an autoimmune disease in which a person's pancreas stops producing insulin. It can impact both children and adults at any age, causing dependence on multiple daily injections of insulin or an insulin pump. Serious short and long term complications stemming from high blood sugar levels can lead to kidney failure, blindness, nerve damage, heart attack, and stroke. Low levels can be life-threatening, particularly at night when they are most difficult to manage.