期刊
DIABETES CARE
卷 45, 期 9, 页码 2076-2083出版社
AMER DIABETES ASSOC
DOI: 10.2337/dc22-0438
关键词
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资金
- Swiss Helmut Horten Foundation
- Foundation for Research in Anaesthesiology and Intensive Care Medicine
This study aimed to evaluate the effect of fully closed-loop subcutaneous insulin delivery on glycemic control in insulin-requiring patients undergoing elective surgery. The results showed that the closed-loop group had a significantly higher proportion of time with sensor glucose in the target range compared to the control group, without any episodes of severe hypoglycemia or hyperglycemia with ketonemia.
OBJECTIVE Perioperative management of glucose levels remains challenging. We aimed to assess whether fully closed-loop subcutaneous insulin delivery would improve glycemic control compared with standard insulin therapy in insulin-requiring patients undergoing elective surgery. RESEARCH DESIGN AND METHODS We performed a single-center, open-label, randomized controlled trial. Patients with diabetes (other than type 1) undergoing elective surgery were recruited from various surgical units and randomly assigned using a minimization schedule (stratified by HbA(1c) and daily insulin dose) to fully closed-loop insulin delivery with fast-acting insulin aspart (closed-loop group) or standard insulin therapy according to local clinical practice (control group). Study treatment was administered from hospital admission to discharge (for a maximum of 20 days). The primary end point was the proportion of time with sensor glucose in the target range (5.6-10.0 mmol/L). RESULTS Forty-five patients were enrolled and assigned to the closed-loop (n = 23) or the control (n = 22) group. One patient (closed-loop group) withdrew from the study before surgery and was not analyzed. Participants underwent abdominal (57%), vascular (23%), orthopedic (9%), neuro (9%), or thoracic (2%) surgery. The mean proportion of time that sensor glucose was in the target range was 76.7 +/- 10.1% in the closed-loop and 54.7 +/- 20.8% in the control group (mean difference 22.0 percentage points [95% CI 11.9; 32.0%]; P < 0.001). No episodes of severe hypoglycemia (<3.0 mmol/L) or hyperglycemia with ketonemia or any study-related adverse events occurred in either group. CONCLUSIONS In the context of mixed elective surgery, the use of fully closed-loop subcutaneous insulin delivery improves glucose control without a higher risk of hypoglycemia.
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