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

January 15, 2024 updated by: Lia Bally

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 hospital costs and readmission rates. Due to the complex interaction of organs involved in glucose homeostasis (e.g. liver, pancreas) and the frequent need for nutrition support, patients undergoing major abdominal surgery are particularly prone to develop dysglycaemia. While there are guidelines for perioperative glucose management, implementation is challenging and inconsistent. Main reasons are lack of resources, clinical inertia based on fear of hypoglycaemia and multiple handovers between teams.

Closed-loop glucose control represents an emerging diabetes treatment modality that autonomously adjusts insulin delivery according to continuously measured glucose levels. The use of fully automated closed-loop insulin delivery may represent an easy-to-adopt approach for safe and effective perioperative diabetes management. In previous work, the investigators demonstrated that fully closed-loop insulin delivery in adults with type 2 diabetes undergoing various elective surgeries (abdominal, vascular, neurologic, orthopaedic, thoracic) improved glycaemic control by increasing time spent in the glycaemic target range, lowering mean sensor glucose and glycaemic variability without increasing the risk of hypoglycaemia.

In this follow-up trial the investigators will focus on patients undergoing major elective abdominal surgery to further explore the potential of the fully automated closed-loop approach to accommodate the complex needs of this population. Involvement of a second study centre and hospital staff for device management will further allow to assess the usability of the fully closed-loop system for larger multi-centre clinical trials as well as readiness to use the approach in usual clinical care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Anaesthesiology, University Hospital Basel
      • Bern, Switzerland, 3010
        • Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Closed-loop insulin therapy

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
Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
Active Comparator: Standard insulin therapy
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
Standard insulin therapy according to local clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission until a maximum of 20 days following surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose <3.0 mmol/L
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose < 3.9 mmol/L
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission until a maximum of 20 days following surgery
Average of sensor glucose level
Time Frame: Assessed from hospital admission or until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
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)
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission until a maximum of 20 days following surgery
Standard deviation of sensor glucose levels
Time Frame: Assessed from hospital admission or until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission or until a maximum of 20 days following surgery
Coefficient of variation of sensor glucose levels
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
The outcome is based on sensor glucose levels
Assessed from hospital admission until a maximum of 20 days following surgery
Total daily insulin dose
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
Insulin dose received by the patients in units/24h
Assessed from hospital admission until a maximum of 20 days following surgery
Post-surgery comorbidity
Time Frame: Assessed at 30 days following surgery
Assessed using the Comprehensive Complication Index (CCI)
Assessed at 30 days following surgery
Length of hospital stay
Time Frame: Up to 20 days
Assessed based on the information in electronic health records
Up to 20 days
Peri- and postoperative costs (perspectives: hospital, statutory health insurance system)
Time Frame: Assessed from hospital admission until a maximum of 30 days following surgery
Assessed based on the information from device manufacturers, hospital administration system and standard external sources for healthcare utilisation unit costs.
Assessed from hospital admission until a maximum of 30 days following surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of severe hypoglycaemia (< 2.2 mmol/L)
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
Based on point-of-care capillary measurements. This is a safety outcome.
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)
Time Frame: Assessed from hospital admission until a maximum of 20 days following surgery
Based on point-of-care capillary measurements. This is a safety outcome
Assessed from hospital admission until a maximum of 20 days following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lia Bally

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLAB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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