Artificial pancreas technology improved blood glucose control in young children between ages 2 and 5 with type 1 diabetes, according to the results of the Pediatric Artificial Pancreas (PEDAP) Trial, a 13-week randomized controlled trial conducted at three pediatric diabetes centers across the United States. The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, and results were published in the 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 the insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.
The trial enrolled 102 participants between ages 2 and 5, a particularly challenging population when it comes to glycemic control, and randomly assigned them to either the artificial pancreas group or the 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 their pre-study method of blood glucose management and were trained to use the study CGM.
During the 13 weeks, participants in the artificial pancreas group spent 12% more time - approximately three hours per day - within their target blood glucose range compared to the standard care group. The greatest difference in blood glucose control was seen at nighttime, between 10 p.m. and 6 a.m., with artificial pancreas participants spending 18% more time in range than the standard care group. Nighttime control is especially challenging to maintain in children with type 1 diabetes.
Additional measurements of blood glucose control also improved, similar to findings seen in previous artificial pancreas trials in older children and adults.
The trial was conducted at the Center for Diabetes Technology at the University of Virginia, Charlottesville; the Barbara Davis Center for Diabetes at the University of Colorado, Aurora; and Stanford University, Palo Alto, California. Due to emergency pandemic restrictions at the time of the study, more than 80% of the device trainings, and 90% of the study visits overall occurred virtually, suggesting the suitability of the technology for use in remote and underserved areas.
The study also assessed safety of using the artificial pancreas device in young children. Similar numbers of severe hypoglycemia occurred among both study groups. One instance of diabetic ketoacidosis occurred in the artificial pancreas group 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 the investigational closed-loop insulin pumps and infusion supplies and Dexcom Inc. provided the CGM supplies used in the trial.
