Status:
COMPLETED
Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)
Lead Sponsor:
Lia Bally
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Perioperative Hyperglycaemia
Insulin Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05392452
Start Date
August 9 2022
End Date
November 13 2023
Last Update
January 17 2024
Active Locations (2)
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1
Anaesthesiology, University Hospital Basel
Basel, Switzerland, 4031
2
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland, 3010