Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)

NCT05392452 | Completed

• 1 other identifier: CLAB
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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 than type 1 diabetes undergoing elective major abdominal surgery.

Conditions

Perioperative Hyperglycaemia; Insulin Therapy; Elective Surgery; Closed-Loop Glucose Control; Artificial Pancreas; Liver Diseases; Diabetes Mellitus, Type 2; Colon Disease; Gastric Disease; Pancreatic Disease

Keywords

Perioperative Hyperglycaemia; Insulin Therapy; Elective Surgery; Closed-Loop Glucose Control; Artificial Pancreas; Liver Diseases; Diabetes Mellitus, Type 2; Colon Disease; Gastric Disease; Pancreatic Disease

Outcome Measures

Primary Outcomes (1)

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

  The outcome is based on sensor glucose levels

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

Secondary Outcomes (11)

• Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)

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

• Proportion of time spent with sensor glucose <3.0 mmol/L

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

• Proportion of time spent with sensor glucose < 3.9 mmol/L

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

• Average of sensor glucose level

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

• Proportion of time spent with sensor glucose below target (< 5.6 mmol/L)

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

Other Outcomes (2)

• Number of severe hypoglycaemia (< 2.2 mmol/L)

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

• Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)

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

Study Arms (2)

Closed-loop insulin therapy

EXPERIMENTAL

Intervention: Use of a fully-automated closed-loop insulin delivery system from day of admission until hospital discharge (or maximum 20 days).

Device: CamAPS HX

Standard insulin therapy

ACTIVE COMPARATOR

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.

Drug: Standard insulin therapy

Interventions

CamAPS HX DEVICE

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

Closed-loop insulin therapy

Standard insulin therapy DRUG

Standard insulin therapy according to local clinical practice.

Standard insulin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lia Bally: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (2)

Anaesthesiology, University Hospital Basel

Basel, 4031, Switzerland

Location

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Liver Diseases; Diabetes Mellitus, Type 2; Colonic Diseases; Stomach Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Intestinal Diseases; Gastrointestinal Diseases

Study Officials

• Lia Bally, MD PhD

  Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern

  PRINCIPAL INVESTIGATOR

• Thierry Girard, MD

  Anaesthesiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nutrition, Metabolism and Obesity and Head of Research

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: May 26, 2022
• Study Start: August 9, 2022
• Primary Completion: October 16, 2023
• Study Completion: November 13, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CH (2)