The prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
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 based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.
Time frame: Up to 20 days
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Time frame: Up to 20 days
Proportion of time spent with sensor glucose <3.0 mmol/L
Time frame: Up to 20 days
Average of sensor glucose level
Time frame: Up to 20 days
Time spent with sensor glucose below target (5.6 mmol/L)
Time frame: Up to 20 days
Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)
Time frame: Up to 20 days
Standard deviation and coefficient of variation of sensor glucose levels
Time frame: Up to 20 days
Total daily insulin requirements
Time frame: Up to 20 days
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