Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy A Randomized Clinical Trial

Charlotte L. van Veldhuisen, Anouk E. J. Latenstein, Dutch Pancreatic Canc Grp, 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, Marc G. Besselink*, J. Hans DeVries, Sarah E. Siegelaar, Ralph de Vries

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Web of Science)

Abstract

IMPORTANCE Glucose control in patients after total pancreatectomy is problematic because of the complete absence of alpha- and beta-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.

OBJECTIVE To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy.

DESIGN, 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. 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 Utests, with significance set at a 2-sided P

MAIN OUTCOMES AND MEASURES The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL [3.9-10 mmol/L]) as assessed by continuous glucose monitoring.

RESULTS In total, 12 patients (7 men and 3 women; median [IQR] age, 62.5 [43.1-74.0] years) 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 (median, 78.30%; IQR, 71.05%-82.61%) than current diabetes care (median, 57.38%; IQR, 52.38%-81.35%; P = .03). In addition, the time spent in hypoglycemia (

CONCLUSIONS AND RELEVANCE 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.

Original languageEnglish
Article numberY
Pages (from-to)1DUMMY
Number of pages8
JournalJAMA Surgery
Volume157
Issue number10
DOIs
Publication statusE-pub ahead of print - 7 Sep 2022

Bibliographical note

Funding/Support: This study was supported by a grant from the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Amsterdam UMC. Inreda Diabetic supplied the BIHAP systems, the continuous glucose monitoring devices with glucose sensors, infusion sets, pump cartridges, and blood glucose meters with corresponding lancets and test cassettes.

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