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Personalized bionic pancreas increases time in range vs. usual care
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SAN FRANCISCO — A third-generation bionic pancreas that allows for integration with two different commercially available continuous glucose monitoring systems significantly increased time in target glucose range and limited overnight hypoglycemia compared with multiple daily injection or insulin pump regimens, according to a speaker here.
“The iLet is a purpose-built bionic pancreas that provides safe and effective glycemic control to people with type 1 diabetes, similar to previous iterations of the bionic pancreas,” Rabab Z. Jafri, MD, instructor at Harvard Medical School and pediatric endocrinologist at Massachusetts General Hospital, told Endocrine Today. “The iLet received CGM input from either the Dexcom G5 or the Senseonics Eversense CGM and incorporated this into its dosing algorithm seamlessly. This will allow users to choose a CGM based on their individual preferences in the future.”
The Gen3 iLet (Beta Bionics) consists of a dual-chamber insulin pump built to class 3 medical device standards with accuracy consistent with FDA-approved insulin pumps, Jafri said during a presentation. It receives direct CGM information from one of two different platforms and can receive manual user input through a touchscreen. It can be used with either insulin or glucagon alone or both hormones together. The algorithm doses insulin and/or glucagon as needed based on CGM information. The system can be initialized based only on the user’s body weight and then adapts to the user with machine learning, according to Jafri.
Jafri and colleagues compared the iLet system in the insulin-only mode with usual care in a random-order, crossover study with 12 adults with type 1 diabetes who typically used multiple daily injections and 22 who used an insulin pump. The 17 participants at the Massachusetts General Hospital site used the Eversense CGM, those at the Stanford University site used the G5 CGM. The researchers analyzed data from 7 days of usual care and 7 days of iLet use.
There were no differences in mean glucose levels for the iLet (155 mg/dL) vs. usual care (162 mg/dL). Time spent in hypoglycemia — blood glucose levels below 54 mg/dL — was similar for the iLet and usual care (0.6% for both).
“Subjects on [multiple daily injections] at baseline did not experience more hypoglycemia in the first 24 hours despite having long-acting insulin on board,” Jafri said.
Time spent in target glucose range of 70 mg/dL to 180 mg/dL was significantly greater for the iLet (70.1%) vs. usual care (61.5%; P = .006). Time spent in hyperglycemia — blood glucose levels above 180 mg/dL — was significantly less with the iLet (median, 25%; interquartile range, 22-33) vs. usual care (median, 34%; interquartile range, 22-46).
“The iLet [also] increased time in range and reduced overnight hypoglycemia for both pump and MDI users,” Jafri told Endocrine Today.
Jafri said she anticipates the iLet system to be commercially available in the next 2 years.
“There was no special training or run-in period required prior to starting patients on the iLet bionic pancreas, for either pump on multiple daily injection users,” Jafri said in an interview. “The iLet continuously adapts to individual insulin needs and only needs the user's weight to start, without any information about the user's insulin regimen, such as basal rates, carb ratios or correction factors.” – by Jill Rollet
Reference:
Jafri RZ AB, et al. 77-OR. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, San Francisco.
Disclosure: Jafri reports no relevant financial disclosures.