BIHAP improves glucose regulation in patients with insulin-dependent diabetes after total pancreatectomy

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. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking.

A study was conducted to assess the efficacy and safety of the BIHAP in patients after total pancreatectomy.

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. Patients were recruited between August 21 and November 16, 2020. This first-in-patient study began with a feasibility phase in 2 patients. 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. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P < .05.

Results:

• In total, 12 patients were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced.
• The time spent in euglycemia was significantly higher during treatment with the BIHAP than current diabetes care
• In addition, the time spent in hypoglycemia was lower with the BIHAP
• No serious adverse events occurred.

Thus, patients using the BIHAP after total pancreatectomy experienced an increased percentage of time in euglycemia and a reduced percentage of time in hypoglycemia compared with current diabetes care, without apparent safety risks. Larger randomized trials, including longer periods of treatment and an assessment of quality of life, should confirm these findings.

Reference:

van Veldhuisen CL, Latenstein AEJ, Blauw H, et al. Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy: A Randomized Clinical Trial. JAMA Surg. Published online September 07, 2022. doi:10.1001/jamasurg.2022.3702

Keywords:

Bihormonal, artificial, Pancreas, Closed-Loop, Glucose, Control, Current, Diabetes, Care, After, Total, Pancreatectomy, Charlotte L. van Veldhuisen, Anouk E. J. Latenstein, Helga Blauw, Lyan B. Vlaskamp, Michel Klaassen, Daan J. Lips, Bert A. Bonsing, Erwin van der Harst, Martijn W. J. Stommel, Marco J. Bruno, Hjalmar C. van Santvoort, Casper H. J. van Eijck, Susan van Dieren, Olivier R. Busch, JAMA Surgery