| Autor: |
Veldhuisen, C.L. van, Latenstein, A.E.J., Blauw, H., Vlaskamp, L.B., Klaassen, M., Lips, D.J., Bonsing, B.A., Harst, E. van der, Stommel, M.W.J., Bruno, M.J., Santvoort, H.C. van, Eijck, C.H.J. van, Dieren, S. van, Busch, O.R., Besselink, M.G., DeVries, J.H., Dutch Pancreatic Canc Grp |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Zdroj: |
JAMA Surgery, 157(10), 950-957. AMER MEDICAL ASSOC |
| Popis: |
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 U tests, with significance set at a 2-sided P < .05.MAIN OUTCOMES AND MEASURES: The primary outcomewas the percentage of time spent in euglycemia (70-180mg/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 ( |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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