Introduction: Major abdominal surgery predisposes to hyperglycemia due to metabolic stress, inflammation, perioperative nutrition support and medication. The aim of the study was to assess the efficacy of fully closed-loop (FCL) versus usual care (UC) insulin delivery for glycemic management in major abdominal surgery patients.
Methods: In this randomized controlled trial (NCT05392452) we compared perioperative use of the CamAPS HX FCL system (Dexcom G6, YspoPump, SC faster insulin aspart) with UC insulin treatment from admission until hospital discharge (max 20 days) at two tertiary hospitals in Switzerland. The primary endpoint was % time in sensor glucose target range (5.6-10.0mmol/L).
Results: Thirty-seven patients (FCL n=18, UC n=19, 27% female, mean±SD age 66±12 years, BMI 27.8±5.7 kg/m2, HbA1C 6.9±1.0 %) were analyzed. Mean±SD % time in target glucose range (5.6-10.0mmol/L) was 80.1±10.0 % with FCL vs 53.7±19.7 % with UC (p<0.001). Time in hypoglycemia (<3.9mM and <3.0mM) did not differ between groups. Total daily insulin dose was significantly higher in the FCL vs UC group (p<0.001).
Conclusions: Perioperative use of FCL insulin delivery in major abdominal surgery patients with complex medical needs results in significantly better glucose control compared to standard insulin therapy without increasing the risk of hypoglycemia.
G. Krutkyte: None. A. Goerg: None. C.A. Grob: None. G. Beldi: None. A. Wenning: None. R. Hovorka: Other Relationship; CamDiab. Research Support; Abbott, Dexcom, Inc., Ypsomed AG. Speaker's Bureau; Ypsomed AG, Abbott, Novo Nordisk, Novartis Pharmaceuticals Corporation. M.E. Wilinska: Consultant; CamDiab. D. Herzig: Speaker's Bureau; Ypsomed AG. A. Vogt: None. T. Girard: None. L. Bally: None.
Helmut Horten FoundationScherbarth Foundation and intramural grants of the Department of Anaesthesiology and Pain Medicine, University Hospital BernSwiss Foundation for Anaesthesiology and Intensive CareClinic for Anaesthesiology, University Hospital BaselFreiwillige Akademische Gesellschaft Basel