Grant: Project Grant

Insulin-alone artificial pancreas systems improve glucose control compared to conventional pump therapy but clinically significant hyperglycemia (5 to 8 hours per day) still exist. Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of pramlintide with insulin at meal times has shown to improve glucose control by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. We therefore developed a novel insulin-and-pramlintide artificial pancreas that delivers both hormones. In an inpatient 24-hr study, this system has shown to increase time spent in target range, reduce mean glucose, and reduce glucose variability compared to insulin-alone artificial pancreas. In this proposal, we aim to conduct a randomized, controlled, crossover, double-blind trial to compare our novel insulin-and-pramlintide artificial pancreas with insulin-and-placebo artificial pancreas in 26 adults with type 1 diabetes in 4-week, outpatient, free-living setting. Our automated artificial pancreas system is composed of: (i) Dexcom G5 glucose sensor, (ii) Tandem t:slim pumps (to deliver insulin and pramlintide), (iii) an LG Google Nexus Smartphone controller with our dosing algorithms. The primary aim of the study is to assess whether our insulin-and-pramlintide artificial pancreas increases the time spent in target range (3.9-10.0 mmol/L) compared to insulin-plus-placebo artificial pancreas in outpatient, unsupervised, free-living settings. .