Perioperative Fully Closed-loop Versus Usual Care Glucose Management in Adults Undergoing Major Abdominal Surgery: A Two-centre Randomized Controlled Trial

Abstract

Objective: To assess the efficacy and safety of fully closed-loop (FCL) compared with usual care (UC) glucose control in patients experiencing major abdominal surgery-related stress hyperglycemia.

Background: Major abdominal surgery-related stress and periprocedural interventions predispose to perioperative hyperglycemia, both in diabetes and non-diabetes patients. Insulin corrects hyperglycemia effectively, but its safe use remains challenging.

Methods: In this two-centre randomized controlled trial, we contrasted subcutaneous FCL with UC glucose management in patients undergoing major abdominal surgery anticipated to experience prolonged hyperglycemia. FCL (CamAPS HX, Dexcom G6, mylife YpsoPump 1.5x) or UC treatment was used from hospital admission to discharge (max 20 d). Glucose control was assessed using continuous glucose monitoring (masked in the UC group). The primary outcome was the proportion of time with sensor glucose values in a target range of 5.6 to 10.0 mmol/L.

Results: Thirty-seven surgical patients (54% pancreas, 22% liver, 19% upper gastrointestinal, 5% lower gastrointestinal), of whom 18 received FCL and 19 UC glucose management, were included in the analysis. The mean ± SD percentage time with sensor glucose in the target range was 80.1% ± 10.0% in the FCL and 53.7% ± 19.7% in the UC group ( P < 0.001). Mean glucose was 7.5 ± 0.5 mmol/L in the FCL and 9.1 ± 2.4 mmol/L in the UC group ( P = 0.015). Time in hypoglycemia (<3.0 mmol/L) was low in either group. No study-related serious adverse events occurred.

Conclusions: The FCL approach resulted in significantly better glycemic control compared with UC management, without increasing the risk of hypoglycemia. Automated glucose-responsive insulin delivery is a safe and effective strategy to minimize hyperglycemia in complex surgical populations.

Keywords: abdominal surgery; closed-loop glucose control; diabetes technology; perioperative glycaemic control; perioperative hyperglycemia.