Bionic pancreas reduces HbA1c, improves time in range in type 1 diabetes: Pivotal data
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NEW ORLEANS — Adults and children with type 1 diabetes who used an insulin-only bionic pancreas had reduced HbA1c without increasing hypoglycemia and other improved metrics compared with standard of care, researchers reported.
The Insulin-Only Bionic Pancreas Pivotal Trial achieved key primary and secondary endpoints in adults and children with type 1 diabetes, according to data presented during a mini-symposium at the American Diabetes Association Scientific Sessions.
The iLet bionic pancreas (Beta Bionics) is a pocket-sized, wearable, investigational device designed to autonomously determine and deliver insulin doses to control blood glucose levels for people with diabetes. It is designed to be worn like an insulin pump; however, users would enter only their body weight to initialize therapy and would not set any insulin parameters. The device is designed to automatically titrate and infuse insulin without requiring the user to count carbohydrates, set insulin-to-carbohydrate ratios, set insulin basal rates, set correction factors or determine bolus insulin for meals or corrections, according to a company release.
This is a “fairly new and different concept in automation,” Greg Forlenza, MD, associate professor of pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, said during a presentation.
Large, diverse trial
The pivotal trial was designed to evaluate safety and efficacy of the iLet bionic pancreas compared with current standard of care for insulin-treated diabetes over 13 weeks.
“This is the largest randomized controlled trial ever conducted to evaluate the safety and efficacy of an automated insulin delivery system,” Steven J. Russell, MD, PhD, associate professor of medicine at Harvard Medical School and Massachusetts General Hospital, said during the presentation.
The study population consisted of 440 adults and children aged 6 years and older with type 1 diabetes at 16 U.S. sites.
“This randomized trial included a more diverse population of adults with type 1 diabetes than previous pivotal studies of hybrid closed-loop systems with respect to minority representation, method of insulin delivery and HbA1c levels,” Davida Kruger, MSN, APN-BC, nurse practitioner at Henry Ford Health System, said here.
Participants were randomly assigned to the bionic pancreas or to continue their standard of care from January to July 2021. Seventy-seven percent of participants were non-Hispanic white, 10% non-Hispanic Black, 9% Hispanic or Latino and 4% other. The standard of care group was comprised of about one-third on automated insulin delivery systems, one-third on insulin pump therapy with continuous glucose monitoring and one-third on multiple daily injection therapy with CGM, Forlenza said.
The primary outcome was HbA1c at 13 weeks.
Primary analysis results
The primary analysis compared outcomes with the bionic pancreas, using insulin lispro (Humalog, Novo Nordisk) or insulin aspart (NovoLog, Novo Nordisk), with standard of care in 326 adults and children. The remaining 114 adults used the bionic pancreas with rapid-acting insulin (Fiasp, Novo Nordisk).
At 13 weeks, the following outcomes were improved over standard of care:
- Significant reduction in HbA1c: At 13 weeks, mean HbA1c was reduced by 0.5% in the bionic pancreas group vs. standard of care (P < .001). In those with baseline HbA1c higher than 7%, the mean HbA1c reduction was 0.7% for the bionic pancreas group vs. standard of care (P < .001).
- No increase in hypoglycemia: Those who used the bionic pancreas did not experience any significant increase in average time spent with CGM values less than 54 mg/dL over 13 weeks compared with standard of care (P < .001 for noninferiority).
- Increased time in range: Those who used the bionic pancreas had an average of 2.6 hours more time in range (70-180 mg/dL) per day over 13 weeks vs. standard of care (P < .001).
Additional analyses
Kruger reported results from 161 adults using insulin aspart or lispro. In this cohort, mean HbA1c decreased from 7.6% at baseline to 7.1% at 13 weeks in the bionic pancreas group vs. 7.5% in the standard of care group (P < .001). Moreover, HbA1c improvement greater than 0.5% at 13 weeks occurred in 43% of the bionic pancreas group vs. 17% of the standard of care group (P < .001) and greater than 1% in 23% vs. 4%, respectively (P < .001). Greater improvements occurred in those with higher baseline HbA1c levels, Kruger said.
Time in range improved after just 1 day of use of the bionic pancreas, Kruger said. At 13 weeks, those assigned the bionic pancreas spent 11% more time in range (2.6 hours per day) compared with standard of care (P < .001). The researchers reported no difference in time spent below 54 mg/dL.
Seven severe hypoglycemia events were reported in the bionic pancreas group (25.5 per 100 person-years) and two in the standard of care group (14.2 per 100 person-years). No diabetic ketoacidosis events occurred. Thirty hyperglycemia adverse events associated with infusion set failures occurred in the bionic pancreas group (failure rate = 0.9 for 3,203 infusion sets), according to the presentation.
Laurel H. Messer, PhD, presented results from 165 children using insulin aspart or lispro. In the pediatric cohort, mean HbA1c decreased from 8.1% at baseline to 7.5% at 13 weeks in the bionic pancreas group and remained steady at 7.8% in the standard of care group (P < .001). HbA1c improvement greater than 0.5% at 13 weeks occurred in 51% of the bionic pancreas group vs. 17% of the standard of care group (P < .001) and greater than 1% in 29% vs. 6%, respectively (P < .001). As in adults, greater improvements in HbA1c occurred in those with higher levels at baseline.
At 13 weeks, those assigned the bionic pancreas spent 10% more time in range (2.4 hours per day) compared with standard of care (P < .001). Again, there was no difference in time spent with glucose below 54 mg/dL, Messer said.
Three severe hypoglycemia events were reported in the bionic pancreas group (10.4 per 100 person-years) and one in the standard of care group (7.3 per 100 person-years). No DKA events occurred. There were 30 hyperglycemia adverse events associated with infusion set failures in the bionic pancreas group (failure rate = 3% for 3,420 infusion sets), according to the presentation.
In these analyses, Kruger said the benefits of the bionic pancreas were “more prominent in multiple daily injection users without having a pre-randomization run-in period to initiate pump use, and the benefit was seen across race/ethnicity and socioeconomic status subgroups.”
In another analysis, Russell highlighted a comparison of the bionic pancreas using rapid-acting insulin aspart (n = 114 adults) compared with standard of care (n = 54 adults) and compared with the bionic pancreas using insulin aspart or insulin lispro (n = 107 adults).
“Compared with standard care, HbA1c was improved with the bionic pancreas using fast-acting insulin aspart without increasing CGM-measured hypoglycemia,” Russell said.
At 13 weeks, mean HbA1c decreased from 7.8% to 7.1% in the rapid-acting insulin aspart group and from 7.6% to 7.1% in the insulin aspart/lispro group (P < .001 for both).
“Compared with the bionic pancreas using insulin aspart or lispro, there was no difference in HbA1c, no difference in mean glucose, a 2% difference in mean time in range due to differences during the daytime, an increase in the proportion with time in range greater than 70% and no significant difference in the proportion with an increase in time in range by 5% or more or 10% or more,” Russell said.
In other results, there were no differences between the groups across nine patient-reported outcome surveys, according to Russell.
Jill Weissberg-Benchell, PhD, CDCES, with Ann and Robert H. Lurie Children’s Hospital of Chicago, reported additional patient-reported outcomes. Adults using the bionic pancreas cited reduced diabetes distress, improved fear of hypoglycemia and improved well-being. Among pediatric patients using the device, distress at baseline was associated with a steeper decrease in HbA1c compared with the standard of care group, Weissberg-Benchell said. Parents of the children in the study also reported satisfaction and acceptability of the bionic pancreas, she said.
Taken together, “Compared to a challenging standard of care, the bionic pancreas reduced HbA1c by a clinically significant margin (0.5%) overall and in subgroups; did not increase hypoglycemia; increased time in range by 2.4 to 3.1 hours per day; decreased mean glucose, time above 180 mg/dL and above 250 mg/dL; gave reasonable control of glycemia without CGM input; and autonomously produced and updated an open-loop regimen that gave reasonable control of glycemia,” Russell said.
Reference:
- The iLet bionic pancreas significantly reduced HbA1c and improved time in range vs standard of care for a diverse range of people with type 1 diabetes. Published April 30, 2022. Accessed June 6, 2022.
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Forlenza G, et al. The Insulin-Only Bionic Pancreas Pivotal Trial – Randomized Clinical Trial Results. Presented at: American Diabetes Association Scientific Sessions; June 3-7, 2022; New Orleans (hybrid meeting).
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