TY - JOUR
T1 - Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy A Randomized Clinical Trial
AU - van Veldhuisen, Charlotte L.
AU - Latenstein, Anouk E. J.
AU - Dutch Pancreatic Canc Grp
AU - Blauw, Helga
AU - Vlaskamp, Lyan B.
AU - Klaassen, Michel
AU - Lips, Daan J.
AU - Bonsing, Bert A.
AU - van der Harst, Erwin
AU - Stommel, Martijn W. J.
AU - Bruno, Marco J.
AU - van Santvoort, Hjalmar C.
AU - van Eijck, Casper H. J.
AU - van Dieren, Susan
AU - Busch, Olivier R.
AU - Besselink, Marc G.
AU - DeVries, J. Hans
AU - Siegelaar, Sarah E.
AU - de Vries, Ralph
N1 - 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.
PY - 2022/9/7
Y1 - 2022/9/7
N2 - 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 PMAIN 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.
AB - 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 PMAIN 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.
U2 - 10.1001/jamasurg.2022.3702
DO - 10.1001/jamasurg.2022.3702
M3 - Article
VL - 157
SP - 1DUMMY
JO - JAMA Surgery
JF - JAMA Surgery
SN - 2168-6254
IS - 10
M1 - Y
ER -
