The purpose of the study is to assess the efficacy, safety and usability of perioperative fully-automated closed-loop insulin delivery versus standard insulin therapy in patients with diabetes other than type 1 diabetes undergoing elective major abdominal surgery.
The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated not only with greater complication rates, length of stay, morbidity and mortality rates, but also increased hospital costs and readmission rates. Due to the complex interaction of organs involved in glucose homeostasis (e.g. liver, pancreas) and the frequent need for nutrition support, patients undergoing major abdominal surgery are particularly prone to develop dysglycaemia. While there are guidelines for perioperative glucose management, implementation is challenging and inconsistent. Main reasons are lack of resources, clinical inertia based on fear of hypoglycaemia and multiple handovers between teams. Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management. In previous work, the investigators demonstrated that fully closed-loop insulin delivery in adults with type 2 diabetes undergoing various elective surgeries (abdominal, vascular, neurologic, orthopaedic, thoracic) improved glycaemic control by increasing time spent in the glycaemic target range, lowering mean sensor glucose and glycaemic variability without increasing the risk of hypoglycaemia. In this follow-up trial the investigators will focus on patients undergoing major elective abdominal surgery to further explore the potential of the fully automated closed-loop approach to accommodate the complex needs of this population. Involvement of a second study centre and hospital staff for device management will further allow to assess the usability of the fully closed-loop system for larger multi-centre clinical trials as well as readiness to use the approach in usual clinical care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
Standard insulin therapy according to local clinical practice.
Anaesthesiology, University Hospital Basel
Basel, Switzerland
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose <3.0 mmol/L
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose < 3.9 mmol/L
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Average of sensor glucose level
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission or until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose below target (< 5.6 mmol/L)
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Standard deviation of sensor glucose levels
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission or until a maximum of 20 days following surgery
Coefficient of variation of sensor glucose levels
The outcome is based on sensor glucose levels
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Total daily insulin dose
Insulin dose received by the patients in units/24h
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Post-surgery comorbidity
Assessed using the Comprehensive Complication Index (CCI)
Time frame: Assessed at 30 days following surgery
Length of hospital stay
Assessed based on the information in electronic health records
Time frame: Up to 20 days
Peri- and postoperative costs (perspectives: hospital, statutory health insurance system)
Assessed based on the information from device manufacturers, hospital administration system and standard external sources for healthcare utilisation unit costs.
Time frame: Assessed from hospital admission until a maximum of 30 days following surgery
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