In addition, the time spent in hypoglycemia (<70 mg/dL ) was lower with the BIHAP (median, 0.00% vs 1.61% P = .004). The time spent in euglycemia was significantly higher during treatment with the BIHAP (median, 78.30% IQR, 71.05%-82.61%) than current diabetes care (median, 57.38% IQR, 52.38%-81.35% P = .03).

Results In total, 12 patients (7 men and 3 women median age, 62.5 years) were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced. Main Outcomes and Measures The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL ) as assessed by continuous glucose monitoring. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P <. Subsequently, 12 patients were randomly assigned to 7-day treatment with the BIHAP (preceded by a 5-day training period) followed by 7-day treatment with current diabetes care, or the same treatments in reverse order. This first-in-patient study began with a feasibility phase in 2 patients. Patients were recruited between August 21 and November 16, 2020. Objective To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy.ĭesign, Setting, and Participants This randomized crossover clinical trial compared the fully closed-loop BIHAP with current diabetes care (ie, insulin pump or pen therapy) in 12 adult outpatients after total pancreatectomy. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking. Importance Glucose control in patients after total pancreatectomy is problematic because of the complete absence of α- and β-cells, leading to impaired quality of life.

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