The device known as Bionic Pancreas using next generation technology to automatically deliver insulin, is proving to be more effective at maintaining blood glucose levels within normal range than standard care management among people with type 1 diabetes.
A new multicenter clinical trial has been primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) https://www.niddk.nih.gov within NIH. The 13 week trial conducted at 16 clinical sites across the U.S, enrolled 326 participants ages 6 to 79 years who had type 1 diabetes and had been using insulin for at least one year.
For participants using the bionic pancreas, glycated hemoglobin, a measure of a person’s long term blood glucose control improved from 7.9% to 7.3% yet remained unchanged among the standard of care control group.
All participants in the control group were provided with a continuous glucose monitor and in the group using the bionic pancreas, glycated hemoglobin, improved from 7.9% to 7.3%, yet remained unchanged among the standard-of-care control group. Also, the bionic pancreas group spent 11% more time per day within the targeted blood glucose range as compared to the control group.
This study is one of several pivotal trials funded by NIDDK to advance artificial pancreas technology and to look at factors including safety, efficacy, user friendliness, cost, plus physical and emotional health of participants. To date, these trials have provided safety and efficacy data needed for regulatory review and licensure to make the technology commercially available.