Clinical trial NCT05392452: Fully Closed-Loop Insulin Delivery in Abdominal Surgery (CLAB)
Official title: Fully Closed-Loop Insulin Delivery in Abdominal Surgery: a Randomised Controlled Two-centre Trial (CLAB-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2022-05-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
Secondary outcomes:
measure: Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Proportion of time spent with sensor glucose <3.0 mmol/L
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Proportion of time spent with sensor glucose < 3.9 mmol/L
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Average of sensor glucose level
timeFrame: Assessed from hospital admission or until a maximum of 20 days following surgery
measure: Proportion of time spent with sensor glucose below target (< 5.6 mmol/L)
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Standard deviation of sensor glucose levels
timeFrame: Assessed from hospital admission or until a maximum of 20 days following surgery
measure: Coefficient of variation of sensor glucose levels
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Total daily insulin dose
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Post-surgery comorbidity
timeFrame: Assessed at 30 days following surgery
measure: Length of hospital stay
timeFrame: Up to 20 days
measure: Peri- and postoperative costs (perspectives: hospital, statutory health insurance system)
timeFrame: Assessed from hospital admission until a maximum of 30 days following surgery
Other outcomes:
measure: Number of severe hypoglycaemia (< 2.2 mmol/L)
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
measure: Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)
timeFrame: Assessed from hospital admission until a maximum of 20 days following surgery
Locations:
city: Basel
country: Switzerland
facility: Anaesthesiology, University Hospital Basel
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
name: Lia Bally, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anaesthesiology, University Hospital Basel
name: Thierry Girard, MD
role: PRINCIPAL_INVESTIGATOR
References: