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PERIOPERATIVE CLOSED-LOOP INSULIN DELIVERY VERSUS STANDARD INSULIN THERAPY - A RANDOMISED CONTROLLED PARALLEL CLINICAL TRIAL IN ADULTS WITH TYPE 2 DIABETES
Abstract
Background and Aims
Given the increasing prevalence and clinical relevance of perioperative hyperglycaemia, there is an ongoing interest in development of novel approaches to optimize glycaemic control in the surgical population. We evaluated the efficacy and safety of fully automated closed-loop (CL) compared with standard insulin therapy in adults with type 2 diabetes (T2D) undergoing elective surgery.
Methods
In an open-label, single-centre, randomised, parallel study, 45 adults with T2D (15 females, mean±SD: age 68±12years, HbA1c 7.5±1.8%) undergoing elective surgery (55.6% abdominal, 22.2% cardiovascular, 2.2% thoracic, 6.7% neurosurgerical, 11.1% orthopaedic) were randomized to either receive fully CL glucose control (CamAPS HX) using Fiasp or standard insulin therapy (control). The primary outcome was the %time from hospital admission to discharge with glucose levels within the target range (5.6 to 10.0mmol/L), as measured by continuous glucose monitoring. Trial registration NCT04361799.
Results
Twenty-three were assigned to CL, and 22 to the control group. The %time in target glucose range (5.6 to 10.0mmol/L) was 74.8±10.3% with CL vs. 53.9±20.6% with control; mean difference 20.9% [95%CI 10.9 to 30.9%]; P<0.001). Mean glucose was lower with CL than control (8.0±0.7 vs. 9.4±2.5mmol/L; P=0.026). Time in hypoglycaemia did not differ between groups (<3.0mmol/L; median[IQR] 0.0 [0.0;0.02%] vs. 0.0[0.0;0.2%]; P=0.92. No between-group difference was observed for total daily insulin requirements (P=0.72) and length of surgery (P=0.52). No study-related serious adverse events occurred in either group.
Conclusions
Fully CL improved glucose control without increasing the risk of hypoglycaemia compared to standard insulin therapy in adults with T2D undergoing elective surgery.