Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB) (CLAB)
Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery
About this trial
This is an interventional treatment trial for Perioperative Hyperglycaemia focused on measuring Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas, Liver Diseases, Diabetes Mellitus, Type 2, Colon Disease, Gastric Disease, Pancreatic Disease
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or over
- Pre-existing or anticipated (surgery-induced) diabetes other than type 1 diabetes
- Expected to require insulin treatment in the perioperative period
- Planned for elective major abdominal surgery at the University Hospital Bern or Basel expected to last ≥ 90 minutes, defined as colorectal, pancreatic, gastric (except bariatric surgery) and hepatic (≥ 2 segments) surgery
Exclusion Criteria:
- Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Likely discharge earlier than 72 hours
- Known or suspected allergy to insulin used in this clinical trial
- Type 1 diabetes
- Pregnancy, planned pregnancy, or breast feeding
- Lack of safe contraception for female participants of childbearing potential for the entire study duration (medically reliable method of contraception are considered oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or any other methods judged as sufficiently reliable by the investigator in individual cases).
- Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- Illicit drug abuse or prescription drug abuse
- Incapacity to give informed consent
- Not willingness to wear study devices 24/7
- Not literate in German
Sites / Locations
- Anaesthesiology, University Hospital Basel
- Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Closed-loop insulin therapy
Standard insulin therapy
Intervention: Use of a fully-automated closed-loop insulin delivery system from day of admission until hospital discharge (or maximum 20 days).
The control group will receive insulin therapy in accordance with local practice. The insulin regimen during the study period may involve subcutaneous and/or insulin intravenous insulin administration. The modality of insulin treatment, dose adjustment and frequency of glucose monitoring will be at the discretion of the clinical team. No active treatment optimisation will be undertaken by the study team. Participants in the control group will be fitted with the identical study CGM system. The CGM system will be blinded upon hospital admission.