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

Diabetes Mellitus, Type 2 Clinical Trial

— CLAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392452
• Other study ID #: CLAB
• Status: Completed
• Phase: N/A
• Start date: August 9, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: January 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 13, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Drug:
• Standard insulin therapy
Standard insulin therapy according to local clinical practice.

Locations

Country	Name	City	State
Switzerland	Anaesthesiology, University Hospital Basel	Basel
Switzerland	Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Lia Bally	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of severe hypoglycaemia (< 2.2 mmol/L)	Based on point-of-care capillary measurements. This is a safety outcome.	Assessed from hospital admission until a maximum of 20 days following surgery
Other	Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)	Based on point-of-care capillary measurements. This is a safety outcome	Assessed from hospital admission until a maximum of 20 days following surgery
Primary	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	Proportion of time spent with sensor glucose values above target (> 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	Proportion of time spent with sensor glucose <3.0 mmol/L	The outcome is based on sensor glucose levels	Assessed from hospital admission until a maximum of 20 days following surgery
Secondary	Proportion of time spent with sensor glucose < 3.9 mmol/L	The outcome is based on sensor glucose levels	Assessed from hospital admission until a maximum of 20 days following surgery
Secondary	Average of sensor glucose level	The outcome is based on sensor glucose levels	Assessed from hospital admission or until a maximum of 20 days following surgery
Secondary	Proportion of time spent with sensor glucose below target (< 5.6 mmol/L)	The outcome is based on sensor glucose levels	Assessed from hospital admission until a maximum of 20 days following surgery
Secondary	Standard deviation of sensor glucose levels	The outcome is based on sensor glucose levels	Assessed from hospital admission or until a maximum of 20 days following surgery
Secondary	Coefficient of variation of sensor glucose levels	The outcome is based on sensor glucose levels	Assessed from hospital admission until a maximum of 20 days following surgery
Secondary	Total daily insulin dose	Insulin dose received by the patients in units/24h	Assessed from hospital admission until a maximum of 20 days following surgery
Secondary	Post-surgery comorbidity	Assessed using the Comprehensive Complication Index (CCI)	Assessed at 30 days following surgery
Secondary	Length of hospital stay	Assessed based on the information in electronic health records	Up to 20 days
Secondary	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.	Assessed from hospital admission until a maximum of 30 days following surgery