NCT05392452Completed
Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)
Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study)
Source: ClinicalTrials.gov · Last updated 17 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 25 Mar 2022
- Start date
- 9 Aug 2022
- Primary completion date
- 16 Oct 2023
- Lead sponsor
- Lia Bally
- Diseases
- Type 2 diabetes
- NCT number
- NCT05392452
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 9 Aug 2022 to the primary completion date, 16 Oct 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Illicit drug abuse or prescription drug abuse
Other illness
- 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
- Known or suspected allergy to insulin used in this clinical trial
- Type 1 diabetes
- Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
Lab values
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
Other
- Likely discharge earlier than 72 hours
- 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).
- Incapacity to give informed consent
- Not willingness to wear study devices 24/7
- Not literate in German
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anaesthesiology, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.