Clinical trial

Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study)

Name

CLAB

Description

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.

Trial arms

Trial start

2022-08-09

Estimated PCD

2023-10-16

Trial end

2023-11-13

Status

Completed

Treatment

CamAPS HX

Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.

Arms:

Closed-loop insulin therapy

Standard insulin therapy

Standard insulin therapy according to local clinical practice.

Arms:

Standard insulin therapy

Size

Primary endpoint

The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L

Assessed from hospital admission until a maximum of 20 days following surgery

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}

Updated at

2024-01-17

1 organization

1 product

11 indications

Organization

Lia Bally

Product

Standard insulin

Indication

Perioperative Hyperglycaemia

Indication