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

Primary Purpose

Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CamAPS HX
Standard insulin therapy
Sponsored by
Lia Bally
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Hyperglycaemia focused on measuring Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas, Liver Diseases, Diabetes Mellitus, Type 2, Colon Disease, Gastric Disease, Pancreatic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closed-loop insulin therapy

Standard insulin therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
The outcome is based on sensor glucose levels
Proportion of time spent with sensor glucose <3.0 mmol/L
The outcome is based on sensor glucose levels
Proportion of time spent with sensor glucose < 3.9 mmol/L
The outcome is based on sensor glucose levels
Average of sensor glucose level
The outcome is based on sensor glucose levels
Proportion of time spent with sensor glucose below target (< 5.6 mmol/L)
The outcome is based on sensor glucose levels
Standard deviation of sensor glucose levels
The outcome is based on sensor glucose levels
Coefficient of variation of sensor glucose levels
The outcome is based on sensor glucose levels
Total daily insulin dose
Insulin dose received by the patients in units/24h
Post-surgery comorbidity
Assessed using the Comprehensive Complication Index (CCI)
Length of hospital stay
Assessed based on the information in electronic health records
Peri- and postoperative costs (perspectives: hospital, statutory health insurance system)
Assessed based on the information from device manufacturers, hospital administration system and standard external sources for healthcare utilisation unit costs.

Full Information

First Posted
March 25, 2022
Last Updated
September 20, 2023
Sponsor
Lia Bally
Collaborators
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT05392452
Brief Title
Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)
Acronym
CLAB
Official Title
Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lia Bally
Collaborators
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop insulin therapy
Arm Type
Experimental
Arm Description
Intervention: Use of a fully-automated closed-loop insulin delivery system from day of admission until hospital discharge (or maximum 20 days).
Arm Title
Standard insulin therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CamAPS HX
Intervention Description
Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
Intervention Type
Drug
Intervention Name(s)
Standard insulin therapy
Intervention Description
Standard insulin therapy according to local clinical practice.
Primary Outcome Measure Information:
Title
The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Secondary Outcome Measure Information:
Title
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Proportion of time spent with sensor glucose <3.0 mmol/L
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Proportion of time spent with sensor glucose < 3.9 mmol/L
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Average of sensor glucose level
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission or until a maximum of 20 days following surgery
Title
Proportion of time spent with sensor glucose below target (< 5.6 mmol/L)
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Standard deviation of sensor glucose levels
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission or until a maximum of 20 days following surgery
Title
Coefficient of variation of sensor glucose levels
Description
The outcome is based on sensor glucose levels
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Total daily insulin dose
Description
Insulin dose received by the patients in units/24h
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Post-surgery comorbidity
Description
Assessed using the Comprehensive Complication Index (CCI)
Time Frame
Assessed at 30 days following surgery
Title
Length of hospital stay
Description
Assessed based on the information in electronic health records
Time Frame
Up to 20 days
Title
Peri- and postoperative costs (perspectives: hospital, statutory health insurance system)
Description
Assessed based on the information from device manufacturers, hospital administration system and standard external sources for healthcare utilisation unit costs.
Time Frame
Assessed from hospital admission until a maximum of 30 days following surgery
Other Pre-specified Outcome Measures:
Title
Number of severe hypoglycaemia (< 2.2 mmol/L)
Description
Based on point-of-care capillary measurements. This is a safety outcome.
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery
Title
Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)
Description
Based on point-of-care capillary measurements. This is a safety outcome
Time Frame
Assessed from hospital admission until a maximum of 20 days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lia Bally, MD PhD
Organizational Affiliation
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Girard, MD
Organizational Affiliation
Anaesthesiology, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anaesthesiology, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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

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