Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy
JAMA Surgery, vol. 157, pp. 950
Abstract
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. 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 U tests, with significance set at a 2-sided P < .05. 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 (<70 mg/dL [3.9 mmol/L]) was lower with the BIHAP (median, 0.00% [IQR, 0.00%-0.07%] vs 1.61% [IQR, 0.80%-3.81%]; P = .004). No serious adverse events occurred. 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. Trial Registration: trialregister.nl Identifier: NL8871.
Authors 18
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St. Antonius Ziekenhuis · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
Department of Research and Development, St Antonius Hospital, Nieuwegein, the Netherlands
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · University of Amsterdam
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands
Amsterdam UMC, Department of Internal Medicine, University of Amsterdam, Amsterdam, the Netherlands
Inreda Diabetic, Goor, the Netherlands
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Affiliation as printed
Inreda Diabetic, Goor, the Netherlands
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Affiliation as printed
Inreda Diabetic, Goor, the Netherlands
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Affiliation as printed
Department of Surgery, Medical Spectrum Twente, Enschede, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands
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Affiliation as printed
Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands
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Radboud University Medical Center
Affiliation as printed
Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands
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University Medical Center Utrecht · St. Antonius Ziekenhuis
Affiliation as printed
Department of Research and Development, St Antonius Hospital, Nieuwegein, the Netherlands
Department of Surgery, University Medical Center Utrecht, Utrecht, the Netherlands
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Affiliation as printed
Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
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Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands
Cancer Center Amsterdam, Amsterdam, the Netherlands
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · University of Amsterdam
Affiliation as printed
Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands
Amsterdam UMC, Department of Internal Medicine, University of Amsterdam, Amsterdam, the Netherlands
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Affiliation as printed
for the Dutch Pancreatic Cancer Group
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Affiliation as printed
for the Dutch Pancreatic Cancer Group
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