Children with Type 1 diabetes will now have access to the Medtronic MiniMed 670G, a hybrid closed-loop system insulin delivery system, following the FDA’s decision to expand the product approval for a younger demographic.
In the device became the first FDA-approved continuous glucose monitoring system that controls automated insulin delivery via a hybrid closed loop system. But at that time it was only cleared for patients over the age of 14. This new clearance now opens up the product to kids between the ages of 7 and 14.
“Type 1 diabetes is a life-threatening chronic condition requiring continuous and life-long management that can be stressful for patients and their caregivers, especially when the patients are young children,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “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. 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. Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks.”
The way the system works is by measuring glucose levels in the users’ body every five minutes and then adjusting the insulin delivery according to the measurement. The goal is for a patient to spend more time in optimal glycemic range, which is 70-180 mg/dL. The system is made up of a sensor attached to the body, an insulin pump, and an infusion patch that connects to the pump with a catheter that delivers insulin, according to an FDA release.
A closed-loop system, often called an “artificial pancreas,” combines a CGM and an insulin pump to regulate a user’s insulin with minimal action required by the patient. This system doesn’t quite do that yet because it requires the user to manually request insulin doses to counter carbohydrate consumption.
This clearance comes after Medtronic conducted research on the MiniMed system on kids ages 7 to 13. In the study the youth group was compared to an adolescence group form ages 14 to 21 and adults over the age of 22. In all three age groups, researchers saw a reduction in HbA1c, a reduction in overall and night time glucose variability, an increase in time in target glucose range, and a reduction of time outside of the goal glucose range.
Treating youth with diabetes has been an area of discussion and research for sometime. Medtronic wasn’t the only group of researchers looking at closed-loop systems in kids. In January a study came out that looked at the use of a closed-loop control system and how it impacted intensive outdoor physical activities for youth aged 10 to 16 years. The study found that participants who used the artificial pancreas maintained a healthy blood sugar level more often than participants that used the traditional open-loop system. In this study researchers used a closed-loop system that the University of Virginia developed.
In the latest approval, the FDA noted that risk associated with the device includes hypoglycemia, hyperglycemia and skin irritation around the device’s infusion patch. The agency is requiring the company to conduct a post-market study on the younger demographic.
"We are thrilled to be able to offer this advanced insulin management system to younger patients and their caregivers to help alleviate some of the burden associated with this unrelenting disease and to improve their quality of life,” Dr Francine Kaufman, chief medical officer and vice president of global regulatory, medical and clinical affairs of the Diabetes Group at Medtronic, said in a statement. "This expanded age indication provides an important new treatment option for pediatric clinicians and parents of young children with type 1 diabetes, and further demonstrates our strong commitment to improving outcomes across the full diabetes care continuum.”