The US Food and Drug Administration (FDA) has extended its approval of the MiniMed 670G system (Medtronic) hybrid closed-looped system for glucose measurement and insulin delivery (so-called artificial pancreas) to include 7 to 13 year olds with type 1 diabetes.
This follows approval of the device in September 2016 for patients with type 1 diabetes aged 14 years and older.
And it comes just as findings from a clinical trial in children are to be presented at the American Diabetes Association (ADA) 2018 Scientific Sessions in Orlando.
"The MiniMed 670G system is the most advanced insulin delivery system on the market today and proven to effectively manage type 1 diabetes," said Jennifer Sherr, MD, a pediatric endocrinologist, diabetes clinic, at Yale New Haven Children's Hospital, and associate professor of pediatric endocrinology at the Yale School of Medicine, Connecticut, in a statement issued by the device maker.
"In the pediatric clinical trial," she continued, "there was an increase in the time in range [the percentage of time spent in the optimal glycemic range of 70 to 180 mg/dL] for sensor glucose values and a reduction in time spent in both hypoglycemia and hyperglycemia, which is compelling in light of the well-known challenges associated with maintaining stable glucose levels throughout the day and night in this younger age group."
"Type 1 diabetes is a life-threatening chronic condition requiring continuous and life-long management that can be stressful for patients and their caregivers," FDA Commissioner Scott Gottlieb, MD, echoed in an FDA press release.
“The round-the-clock glucose monitoring...can be disruptive to people's lives," he noted, and "younger children...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."
When the Pancreas Does Not Supply Insulin...
As reported earlier, the MiniMed 670G hybrid closed-looped system is the first-ever device that automatically monitors blood glucose and administers appropriate basal insulin doses. It is comprised of a subcutaneous continuous glucose monitor that measures glucose levels every 5 minutes and an insulin pump that delivers needed insulin via a catheter based on these glucose values.
Because the device responds to both low and high blood glucose levels it is being called the first-ever artificial pancreas. However, because patients still need to enter information about anticipated meals — a carbohydrate count of the food they are about to eat so that the system can calculate and deliver the needed "bolus" insulin — it is called a hybrid rather than a fully closed-loop system.
The new FDA approval for younger patients is based on data from a clinical trial in 105 children with type 1 diabetes who were 7 to 13 years old.
The children had traditional open-loop mode insulin pump therapy during a 2-week baseline period, followed by 3 months of in-home use of the device with the hybrid closed-loop mode (SmartGuard automode) enabled.
Compared with baseline, when the hybrid closed-loop mode was enabled, the time in range for glucose increased from 56.2% to 65.0% and HbA1c decreased from 7.9% to 7.5%.
The system's potential adverse events include hypoglycemia, hyperglycemia, and skin irritation or redness around the infusion patch. None of the study patients had serious device-related adverse events, severe hypoglycemia, or diabetic ketoacidosis.
And almost all of the children continued to use the device after the end of the study.
As part of this FDA approval, the product developer is conducting a post-marketing study to evaluate how the device performs in a real-world setting in 7- to 13-year-old children.
The device is not approved for children age 6 or younger or individuals who need less than 8 units/day of insulin.
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Cite this: FDA Approves Artificial Pancreas for Children With Type 1 Diabetes - Medscape - Jun 22, 2018.