Artificial pancreas technology improves blood glucose control in young children with type 1 diabetes

Artificial pancreas technology improved blood glucose control in young children ages 2 to 5 with type 1 diabetes, according to results from the Pediatric Artificial Pancreas Trial (PEDAP), a 13-week randomized controlled trial conducted at three diabetes centers. children across the United States. States. The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which is part of the National Institutes of Health, and the results are published in the journal New England Journal of Medicine.

The artificial pancreas, also known as closed-loop control, is an “all-in-one” diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers insulin when needed using an insulin pump. The system replaces test-dependency with fingers, or CGM, with insulin delivery via multiple daily injections or a pump controlled by the patient or caregiver.

The trial had 102 participants between the ages of 2 and 5, a particularly challenging population when it comes to glycemic control, randomly assigned to either an artificial pancreas group or a standard care comparison group. The artificial pancreas group received training on how to use the study device – an insulin pump programmed with Control-IQ insulin dosing technology – and a CGM. The standard care group continued to use the previous study method for blood glucose management and was trained to use the continuous glucose monitoring study.

During the 13 weeks, participants in the artificial pancreas group spent 12% more time — about three hours per day — within their target blood glucose range than in the standard care group. The greatest difference in blood glucose control was seen at night, between 10pm and 6am, when participants in the artificial pancreas spent 18% more time in the band than in the standard care group. Nighttime control is especially difficult to maintain in children with type 1 diabetes.

Additional measures of blood glucose control also improved, similar to results seen in previous artificial pancreas trials in older children and adults.

The trial was conducted at the Diabetes Technology Center at the University of Virginia, Charlottesville. Barbara Davis Diabetes Center at the University of Colorado, Aurora; and Stanford University, Palo Alto, California. Due to emergency epidemiological restrictions at the time of the study, more than 80% of the trainings were on devices, and 90% of the total study visits occurred virtually, indicating the suitability of the technology for use in remote and underserved areas.

The study also evaluated the safety of using an artificial pancreas device in young children. Similar numbers of severe hypoglycemia occurred between the two study groups. One case of diabetic ketoacidosis in the artificial pancreas group occurred due to a problem with the insulin pump tubing called infusion set failure.

Study funding was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (grant # U01DK127551). Tandem Diabetes Care provided pilot closed-loop insulin pumps and infusion supplies, and Dexcom Inc. CGM supplies used in the trial.