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Data from a pivotal trial presented at ATTD 2022 demonstrate the use of the iLet Bionic Pancreas was associated with significant improvements in HbA1c and TIR among a diverse study population of adults and children with type 1 diabetes compared with standard care.
A bionic pancreas may no longer be science fiction and could soon become a reality for patients with type 1 diabetes, according to the results of a trial presented at the 15th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD).
The Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT), a pivotal trial assessing the safety and efficacy of Beta Bionics Incorporated’s iLet Bionic Pancreas, results of the study demonstrated use of the investigational device was associated with significant reductions in HbA1c and improved time in range compared with standard care in patients with type 1 diabetes.
“Compared to what was a very challenging standard of care where 31% of participants used a hybrid closed loop system, and therefore you would predict might not have much potential for improvement in their glucose control, the bionic pancreas reduced A1c by a clinically significant margin of 0.5% consistently. We think this is important because the FDA considers something more than 0.4% to be clinically significant.” said study presenter Stephen Russell, MD, PhD, associate professor of medicine at Harvard Medical School, during his presentation at ATTD 2022. “It did that overall, in all subgroups, and reduced the variation in A1c.”
An investigator-initiated, multicenter, randomized controlled trial funded, in part, by a grant from the National Institutes of Health to Boston University, IO BPPT was led by investigators at the Jaeb Center for Health Research and conducted in 16 medical centers across the US. Launched with the intent of assessing the safety and efficacy of iLet Bionic Pancreas’s insulin dosing configuration compared to standard care, which included both bumps therapy and multiple daily injections (MDI), the trial randomized 440 patients with type 1 diabetes aged 6 years or older to the iLet Bionic Pancreas or standard care for 13 weeks to assess impact on glycemic control.
Produced by Beta Bionics, the iLet Bionic Pancreas is billed as a pocket-sized, wearable device designed to autonomously dose insulin. The device is designed to be worn like an insulin pump, but only requires users to enter their body weight to initialize therapy and would then begin 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.
When enrolling patients in the trial, investigators had a goal to create a more representative study population than seen in previous type 1 diabetes trials. With this in mind, investigators sought to enroll a population where 33% or more were using MDI,33% or more were using an insulin pump, 20% or more had an HbA1c of less than 7%, 33% had an HbA1c greater than 8%, and with an overall population where 15% or more were of minority race/ethnicity. investigators noted there was no upper limit for HbA1c in the trial’s enrollment criteria and any FDA-approved PLGS or hybrid closed loop system were allowed.
Of the 440 patients included in the trial, 275 were adult patients aged 18 years or older. These patients were randomized in a 2:1:2 ratio to bionic pancreas with insulin aspart or insulin lispro, standard care, or bionic pancreas with fast-acting insulin aspart. The remaining 165 patients included in the study were children aged 6 to less than 18 years. These patients were randomized in a 2:1 ratio to the bionic pancreas with insulin aspart of insulin lispro or standard care.
The primary analyses combined results from adults and children using the bionic pancreas with insulin aspart or insulin lispro against standard care. Investigators also conducted prespecified secondary analysis assessing bionic pancreas with insulin aspart or insulin lispro against standard care in children and adults separately as well as in adults with bionic pancreas and fast-acting insulin aspart against standard of care in adult patients.
Upon analysis, results indicated use of the bionic pancreas was associated with a 0.5% reduction in HbA1c at the end of the 13-week study period compared to standard care. In a subgroup analysis of patients with an HbA1c greater than 7% at baseline, the reduction observed with bionic pancreas versus standard of care increased to 0.7%. Additionally, when assessing time in range, results suggested use of the iLet Bionic Pancreas was associated with a mean increase in time in range per day of 2.6 hours compared with standard of care. In a secondary analysis, the mean increase in time in range per day was 2.4 hours among children with type 1 diabetes.
Safety analyses demonstrated use of the bionic pancreas was not associated with any significant increases in mean time spent with CGM values below 54 mg/dL during the study period compared to standard of care. During his presentation, Russell noted severe hypoglycemia events occurred in both arms of the study and none of the events observed in the bionic pancreas arm were due to device malfunction.
“The results of this trial confirm that the iLet Bionic Pancreas may serve a population of people who are otherwise unable to reach glycemic goals with currently available diabetes technology,” said Jeanne Jacoby, FNP, CDCES, Director of Medical Affairs, Beta Bionics, in a statement from the company. “As a medical professional and a person with diabetes, I look forward to us being able to offer a solution that may change the lives of this underserved population.”
This study, “Results of the Insulin-only Bionic Pancreas Pivotal Trial,” was presented at ATTD 2022.