6/28/23, 11:41 PM Insulin-Only Bionic Pancreas Pathway Feedback Search Clinical Topics Home Studies Insulin-Only Bionic Pancreas Insulin-Only Bionic Pancreas Disease Diabetes mellitus type 1 Trial question What is the role of bionic pancreas in patients with T1DM? Study design Multi-center Open label RCT Population Characteristics of study participants 45.0% female N = 326 55.0% male 326 patients (148 female, 178 male) Inclusion criteria: participants 6 years of age with T1DM Key exclusion criteria: plan to change usual diabetes regimen in 3 months; Hgbopathy; history of cystic fibrosisl; pancreatitis; or other pancreatic diseases Interventions N=219 bionic pancreas (automated delivery of insulin aspart or insulin lispro for 13 weeks) N=107 standard care (any insulin-delivery method plus continuous glucose monitoring) Primary outcome Glycated hemoglobin level at week 13 7.7 % 7.7 7.3 5.8 % 3.9 % Significant decrease https://web.pathway.md/studies/recssWOpt6h2cLz9R 1/2 6/28/23, 11:41 PM Insulin-Only Bionic Pancreas Pathway Significant decrease 1.9 % NNT = 250 0.0 % Bionic pancreas Standard care Significant decrease in glycated Hgb level at week 13 (7.3% vs. 7.7%; ARD -0.5, 95% CI -0.6 to -0.3) Secondary outcomes Significant decrease in glucose level at week 13 (164 mg/dL vs. 181 mg/dL; AD -16 mg/dL, 95% CI -19 to -12) Significant increase in the percentage of time with glucose level 70-180 mg/dL at week 13 (65% vs. 54%; AD 11%, 95% CI 9 to 13) Safety outcomes No significant difference in severe hypoglycemia. Conclusion In participants 6 years of age with T1DM, bionic pancreas were superior to standard care with respect to glycated Hgb level at week 13. Reference Bionic Pancreas Research Group, Steven J Russell, Roy W Beck et al. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. N Engl J Med. 2022 Sep 29;387(13):1161-1172. Open reference URL https://web.pathway.md/studies/recssWOpt6h2cLz9R 2/2