Management of type 1 diabetes in pediatric patients could become easier following the approval of an automated insulin delivery and monitoring system for use in children between the ages of seven and 13. Medtronic’s MiniMed 670G hybrid closed loop system monitors glucose levels and automatically provides suitable doses of basal insulin doses with minimal input from users, making it a useful device for managing diabetes in younger patients.
Type 1 diabetes accounts for nearly 98 percent of cases of diabetes in children under 10 years of age and 87 percent of cases in adolescents between ten and 19, according to the latest Diabetes in America report published by the Centers for Disease Control and Prevention (CDC). The SEARCH for Diabetes in Youth Study, funded by the CDC and National Institutes of Health, found the rate of newly diagnosed type 1 diabetes in young patients rose by about 1.8 percent annually between 2002 and 2012.
The condition generally occurs when the insulin-producing cells in the pancreas are attacked by the immune system, resulting in insulin deficiency and hyperglycemia. While the cause of type 1 diabetes is as yet unknown, it is believed to occur when genetically predisposed patients encounter an environmental trigger, which stimulates this immune attack.
Treatment of type 1 diabetes generally involves patients consistently monitoring blood sugar levels during the day and making the appropriate adjustments by administering insulin using a syringe, insulin pen or pump.
“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.
“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.”
Gottlieb observed the frequent blood glucose checks required to manage type 1 diabetes, in particular checks throughout the night, can be highly disruptive to pediatric patients. The extension of the age range for which the MiniMed 670G system is approved extends opportunities for diabetes management to a large group of vulnerable patients, he added.
The device measures glucose levels in the body every five minutes and automatically adjusts the delivery of insulin, either by withholding or administering insulin. A sensor is attached to the body to measure glucose levels beneath the skin, and an insulin pump is strapped to the body. This pump has an infusion patch with a catheter to deliver insulin, adjusting dosage as necessary, although patients do still need to manually request insulin at mealtimes to counter consumption of carbohydrates.
During the clinical trial of the MiniMed 670G hybrid closed loop system, 105 patients between seven and 11 years of age wore the device for 3.5 months. The study evaluated use at home and remote use, concluding the device is suitable for use in people between seven and 13 years who have type 1 diabetes. No serious adverse events were associated with the device, but associated risks include hypoglycemia, hyperglycemia, and irritation or redness of the skin around the infusion patch.
The MiniMed 670G was not the only diabetes management device to gain approval in June 2018, as the FDA also approved the first continuous glucose monitoring system with a fully implantable glucose sensor for use in adults with diabetes. The Eversense Continuous Glucose Monitoring system, which can be worn for up to 90 days and can be synced with compatible mobile apps, was approved for patients aged 18 years and above.
For more information on the MiniMed 670G, visit: https://www.medtronicdiabetes.com/products/minimed-670g-insulin-pump-system