Beta Bionics announced today that a trial of its iLet bionic pancreas met key endpoints, including reduced HbA1c.
Dr. Roy W. Beck and clinical investigators presented the results of the multi-center, randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans.
According to a news release, the trial met key endpoints, including consistently showing reduced mean HbA1c across populations regardless of race, education, or income level in exploratory analyses of subpopulations. Beta Bionics said that Dr. Gregory Forlenza described the study design as enabling the iLet bionic pancreas to “remove numeracy” from the management of type 1 diabetes.
Beta Bionics designed the pocket-sized, wearable, investigational iLet device to autonomously dose insulin. Worn like an insulin pump, iLet users only enter body weight to initialize therapy without the need for insulin regimen parameters. The company designed the device to then automatically titrate and infuse insulin without requiring the counting of carbs, the settings of certain rates and factors and more. Interim CEO and board member Martha Aronson told Drug Delivery Business News recently that the iLet will help those with diabetes reduce the cognitive burden of managing their disease.
The trial included a more diverse population of participants with type 1 diabetes than pivotal studies of other automated insulin delivery (AID) systems with respect to minority representation, method of insulin delivery and HbA1c levels, Beta Bionics said. Results cover analyses of iLet in adults, youth and combined with Fiasp in adults. Results come on the heels of a presentation for the same trial at ATTD earlier this year that also supported the iLet.
Relative to the standard of care group with continuous glucose monitoring (CGM), iLet produced a mean reduction of HbA1c of 0.5% across all three cohorts (adults, youth and adults using iLet with Fiasp). A total of 43% of adult participants using iLet with Humalog/NovoLog saw a reduction of 0.5% or greater in HbA1c compared to only 17% of those in the standard of care group.
Exploratory analyses of different adult subgroups (race/ethnicity, education, income, and baseline insulin therapies) over 13 weeks showed that HbA1c results were consistently 7.0-7.3% on the iLet Bionic Pancreas with a greater improvement seen in those populations with higher baseline HbA1c.
A subgroup analysis of youth (between six and 17 years old) with initial HbA1c registering greater than 9% demonstrated that those in the bionic pancreas group saw an increase in time in range of 31% compared to the standard of care group, representing an increase equal to an additional 7.4 hours per day. Among the youth group, 51% on iLet with Humalog/NovoLog saw a reduction of 0.5% or greater in HbA1c compared to only 8% in the standard of care group.
In the same age group, 29% of youth saw an HbA1c reduction of 1% or more on iLet with Humalog/NovoLog compared to 6% in the standard of care group. Parents of children in the bionic pancreas group reported a significant increase in diabetes treatment satisfaction.
Additionally, adult users of the bionic pancreas experienced a reduction in diabetes distress and fear of hypoglycemia with statistically significant differences favoring the bionic pancreas group relative to the standard of care group.
“We know that health inequities exist in almost every aspect of healthcare delivery: Type 1 diabetes is no exception,” Aronson said in the release. “Beta Bionics is thrilled to see that exploratory analyses consistently indicate glycemic improvements across race, education, and income from the IO BPPT. This supports our public benefit commitment to making type 1 diabetes management technology accessible to the many.”
The trial sought to reach a broad demographic, including a racial and ethnic composition in the primary analysis that featured participants that were 74% White non-Hispanic, 10% Black non-Hispanic, 10% Hispanic or Latino, and 6% other or more than one race.
Beta Bionics said the trial was funded in part by a grant from the National Institutes of Health to Boston University, and conducted in collaboration with the IDE sponsor and study coordinator, the Jaeb Center for Health Research, and 16 clinical research centers across the U.S.
“As a nurse practitioner and diabetes care and education specialist, I have always said a diagnosis of diabetes does not come with a math degree,” Beta Bionics Director of Medical Affairs Jeanne Jacoby said. “I was excited to see that the exploratory sub-group analysis shows consistently reduced mean HbA1c regardless of education level for those in the bionic pancreas group.”