1257-OR: Glucose Control during Three-Month Treatment with a Bihormonal Artificial Pancreas vs. Current Diabetes Care in Patients following Total Pancreatectomy (PANORAMA): A Randomised Crossover Trial

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Introduction and Objective: In patients undergoing total pancreatectomy (TP), adequate glycemic control is a major concern. Previously, a 7-day treatment with a bihormonal artificial pancreas (BIHAP), delivering both insulin and glucagon for fully closed-loop regulation, improved glycemic control. However, evidence on its long-term efficacy is lacking.Methods: This randomised open-label crossover trial compared BIHAP treatment with current diabetes care in adults after TP. Participants were randomised (1:1) to start with BIHAP or current diabetes care for 3 months, followed by a 3-month washout and crossover to the alternate treatment. The primary endpoint was the proportion of time spent in range (3.9 to 10.0 mmol/L; 70 to 180 mg/dL). The key secondary multiplicity-controlled endpoint was glycated hemoglobin (HbA1c).Results: Between April 26, 2023 and November 8, 2024, 34 patients were randomised. As predefined, those who completed both treatment periods were included in the primary analysis (n=20; 70% [n=14] male; median age, 65 years [IQR, 57 to 70]). During the standard care period, insulin was delivered by multiple daily injections in 16 patients and via insulin pump therapy in 4 patients; all patients used continuous glucose monitoring. The proportion of time spent in range was 24% higher (95% CI, 16 to 32; P<0.0001) with BIHAP compared with current diabetes care (mean [SD], 81% [7] vs 57% [19]). Glycated hemoglobin was 8 mmol/mol lower (IQR, 4 to 13; P=0.001) after BIHAP treatment (mean [SD], 56 mmol/mol [10] vs 64 mmol/mol [14]). Time below range (<3.9 mmol/L) was 0.9% (SD 0.8) with BIHAP versus 1.2% (SD 1.1) with current care (mean difference, -0.3; 95% CI, -0.8 to 0.3).Conclusion: In patients after TP, 3 months treatment with a fully closed-loop BIHAP significantly improved time in range and glycated hemoglobin levels compared with current diabetes care. These findings support the use of BIHAP in this population.

Disclosure

C. Leseman: None. J. De Vries: Consultant; Current; Gan & Lee Pharmaceuticals. Advisory Panel; Ended; Liom. Speaker’s Bureau; Ended; Novo Nordisk A/S.

Funding

Dutch Cancer Society (14502); Inreda Diabetic B.V. provided medical devices under study (BIHAP 5, Inreda Diabetic B.V, Goor, the Netherlands)



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