Artificial pancreas technologies enhanced blood glucose handle in young youngsters amongst ages two and five with variety 1 diabetes, according to the benefits of the Pediatric Artificial Pancreas (PEDAP) Trial, a 13-week randomized controlled trial carried out at 3 pediatric diabetes centers across the United States. The study was funded by the National Institute of Diabetes and Digestive and Kidney Ailments (NIDDK), component of the National Institutes of Well being, and benefits have been published in the New England Journal of Medicine.
The artificial pancreas, also recognized as closed-loop handle, is an “all-in-one particular” diabetes management technique that tracks blood glucose levels applying a continuous glucose monitor (CGM) and automatically delivers the insulin when necessary applying an insulin pump. The technique replaces reliance on testing by fingerstick or CGM with delivery of insulin by a number of every day injections or a pump controlled by the patient or caregiver.
The trial enrolled 102 participants amongst ages two and five, a specifically difficult population when it comes to glycemic handle, and randomly assigned them to either the artificial pancreas group or the common care comparison group. The artificial pancreas group received coaching on how to use the study device — an insulin pump programmed with Manage-IQ insulin dosing technologies — and a CGM. The common care group continued to use their pre-study approach of blood glucose management and have been educated to use the study CGM.
Through the 13 weeks, participants in the artificial pancreas group spent 12% additional time — roughly 3 hours per day — inside their target blood glucose variety compared to the common care group. The greatest distinction in blood glucose handle was observed at nighttime, amongst ten p.m. and six a.m., with artificial pancreas participants spending 18% additional time in variety than the common care group. Nighttime handle is specially difficult to retain in youngsters with variety 1 diabetes.
More measurements of blood glucose handle also enhanced, comparable to findings observed in earlier artificial pancreas trials in older youngsters and adults.
The trial was carried out at the Center for Diabetes Technologies 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, additional than 80% of the device trainings, and 90% of the study visits general occurred practically, suggesting the suitability of the technologies for use in remote and underserved locations.
The study also assessed security of applying the artificial pancreas device in young youngsters. Related numbers of extreme hypoglycemia occurred amongst each study groups. 1 instance of diabetic ketoacidosis occurred in the artificial pancreas group due to a trouble with the insulin pump tubing known as infusion set failure.
Study funding was offered by the National Institute of Diabetes and Digestive and Kidney Ailments (grant # U01DK127551). Tandem Diabetes Care offered the investigational closed-loop insulin pumps and infusion supplies and Dexcom Inc. offered the CGM supplies employed in the trial.
Supply:
National Institutes of Well being
Journal reference:
Wadwa, R.P.., et al. (2023) Trial of Hybrid Closed-Loop Manage in Young Youngsters with Sort 1 Diabetes. New England Journal of Medicine. doi.org/ten.1056/NEJMoa2210834.