Perioperative HyperglycaemiaCLABNCT05392452
Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)
A study testing CamAPS HX and Standard insulin therapy in people with Perioperative Hyperglycaemia and Insulin Therapy, run by Lia Bally at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery
- What is being tested?
- CamAPS HX and Standard insulin therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 9 Aug 2022to 13 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Anaesthesiology, University Hospital Basel
Basel, 4031
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: 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.
Read the 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.
- Conditions
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas, Liver Diseases
- Being tested
- CamAPS HX, Standard insulin therapy
- 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
- Medical subject headings
- Liver Diseases, Diabetes Mellitus, Type 2, Colonic Diseases, Stomach Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPS HXDevice
Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
Standard insulin therapyDrug
Standard insulin therapy according to local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Standard insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
The outcome is based on sensor glucose levels
Measured: Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose <3.0 mmol/L
The outcome is based on sensor glucose levels
Measured: Assessed from hospital admission until a maximum of 20 days following surgery
Proportion of time spent with sensor glucose < 3.9 mmol/L
The outcome is based on sensor glucose levels
Measured: Assessed from hospital admission until a maximum of 20 days following surgery
Average of sensor glucose level
The outcome is based on sensor glucose levels
Measured: 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)
The outcome is based on sensor glucose levels
Measured: Assessed from hospital admission until a maximum of 20 days following surgery
Standard deviation of sensor glucose levels
The outcome is based on sensor glucose levels
Measured: Assessed from hospital admission or until a maximum of 20 days following surgery
Coefficient of variation of sensor glucose levels
The outcome is based on sensor glucose levels
Measured: Assessed from hospital admission until a maximum of 20 days following surgery
Total daily insulin dose
Insulin dose received by the patients in units/24h
Measured: Assessed from hospital admission until a maximum of 20 days following surgery
Post-surgery comorbidity
Assessed using the Comprehensive Complication Index (CCI)
Measured: Assessed at 30 days following surgery
Length of hospital stay
Assessed based on the information in electronic health records
Measured: Up to 20 days
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.
Measured: Assessed from hospital admission until a maximum of 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start9 Aug 2022
- Primary completion16 Oct 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HyperglycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lia Bally
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Lia Bally, Insel Gruppe AG, University Hospital Bern
- Investigators
- Lia Bally, MD PhD, Principal investigator, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of BernThierry Girard, MD, Principal investigator, Anaesthesiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392452
- Sponsor's protocol ID
- CLAB
- Acronym
- CLAB
- Status last verified
- Jan 2024
- First submitted
- 25 Mar 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study)
- ClinicalTrials.gov ID
- NCT05392452
- Acronym / sponsor ID
- CLAB / CLAB
- Conditions
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas, Liver Diseases
- Keywords
- Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas, Liver Diseases, Diabetes Mellitus, Type 2, Colon Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Lia BallyUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop insulin therapy | Experimental | Device: CamAPS HXIntervention: Use of a fully-automated closed-loop insulin delivery system from day of admission until hospital discharge (or maximum 20 days). |
| Standard insulin therapy | Active comparator | Drug: Standard insulin therapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamAPS HXFully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements. | Device | Closed-loop insulin therapy |
| Standard insulin therapyStandard insulin therapy according to local clinical practice. | Drug | Standard insulin therapy |
Primary outcome
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
11 secondary outcomes
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
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
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
Average of sensor glucose level
Time frame: 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
Standard deviation of sensor glucose levels
Time frame: 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
Total daily insulin dose
Time frame: Assessed from hospital admission until a maximum of 20 days following surgery
Post-surgery comorbidity
Time frame: Assessed at 30 days following surgery
Length of hospital stay
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Bally, MD PhD principal investigator
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
Thierry Girard, MD principal investigator
Anaesthesiology, University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CamAPS HX and Standard insulin therapy in people with Perioperative Hyperglycaemia and Insulin Therapy, run by Lia Bally at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.