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Investigational patch-pump artificial pancreas safe, effective under free-living conditions
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ORLANDO, Fla. — Among adults with type 1 diabetes participating in a free-living study, a preliminary Omnipod closed-loop insulin-delivery system yielded better overall and nighttime glycemic control compared with the users’ standard therapy, according to a speaker here.
The system features an Omnipod (Insulet) insulin pump, a tablet computer, a Dexcom G3 glucose monitor and a personal data monitor, according to Bruce A. Buckingham, MD, professor of pediatrics and endocrinology at Stanford Children’s Health Center, Stanford University.
“The system we’re testing is not the final product,” Buckingham said during a press briefing. “What’s unique about the system is the pod is worn on the body. There’s no tubing, and in the finalized version it will be a system such as the Dexcom G6 talking directly to the pod, and the algorithm will reside on the pod. Our goal in doing these studies has been to develop the algorithm and improve it under a series of different conditions.”
Buckingham and colleagues enrolled 11 adults with type 1 diabetes (mean age, 29 years; mean diabetes duration, 15 years; mean HbA1c, 7.4%) to use the closed-loop system for 5 days and 4 nights in a hotel setting with no restrictions on meals or exercise. The researchers compared those data with information from the previous 7 days during which patients followed their usual diabetes regimen (three multiple daily injection users; eight insulin pump users).
During the closed-loop portion of the study, mean daily exercise was 54 minutes (range, 14-127 minutes). Mean meal size included approximately 53 g carbohydrates, with a maximum of 194 g.
Mean glucose level was not significantly lower during closed-loop use (150 mg/dL) vs. standard care (156 mg/dL). However, percent time with glucose level below 70 mg/dL decreased by 3.2% overall with a goal less than 4% for the closed-loop system vs. usual care (1.9% vs. 5.1%; P = .001). Percent time in upper glucose ranges also improved with the closed-loop system: above 180 mg/dL (24.5% vs. 32.3%; P = .12) and above 250 mg/dL (4.5% vs. 8.5%; P = .01). Time spent in range between 70 mg/dL and 180 mg/dL increased by 11.2% overall with the closed-loop system vs. usual care, to 73.7% (treatment goal, 70%) vs. 62.5% (P = .02).
Overnight, the closed-loop system again performed better than usual care: time with glucose below 70 mg/dL was 5% lower overnight (0.7% vs. 5.7%; P = .02), and time in range 70 mg/dL to 180 mg/dL was 13.2% higher overnight (73.9% vs. 60.7%; P = .03).
“The plan … is that they’re really trying to test a broad range [of populations], so we’re now doing studies in 2- to 4-year-olds as well as in adults,” Buckingham said. “The algorithm is continually being improved and adapted with each one of these clinical trials, so when it comes time to put it in a truly ambulatory system, it will be a really solid system.” – by Jill Rollet
Reference:
Buckingham B, et al. 207-OR. Presented at: American Diabetes Association 78th Scientific Sessions; June 22-26, 2018; Orlando, Fla.
Disclosures: Buckingham reports he receives research funding from Dexcom, Helmsley Foundation, Insulet, Medtronic and Tandem, and is an advisory board member for ConvaTec and Novo Nordisk. Please see the abstract for all other authors’ relevant financial disclosures.