Clinical trial NCT04361799: Perioperative Closed-loop Glucose Control
Official title: Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Hyperglycaemia
Insulin Therapy
Elective Surgery
Closed-Loop Glucose Control
Artificial Pancreas
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 45
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 prevalence of diabetes and hyperglycaemia in surgical patients is rising and associated with grater complication rates, length of stay and mortality rates. Suboptimal glucose management in the perioperative setting remains a major barrier to optimal surgical care. While there are guidelines to manage perioperative diabetes care, implementation is challenging and inconsistent, in part due to a stretched workforce, involvement of several disciplines and clinical teams and shortcomings in clinical training and knowledge. 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.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* The subject is aged 18 years or over
* Diagnosis of type 2 diabetes using standard diagnostic practice (37)
* The subject is planned for an elective abdominal, thoracic or cardiovascular surgery at the University Hospital Bern expected to last ≥2 hours
* The subject requires treatment with subcutaneous insulin as part of the perioperative glucose management
* The subject is literate in German
* The subject is willing to wear study devices 24/7

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
* Known or suspected allergy to insulin
* Type 1 diabetes
* Pregnancy, planned pregnancy, or breast feeding
* Medically documented allergy towards the adhesive (glue) of plasters or unable tolerate tape adhesive in the area of sensor placement
* 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).
* 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
* Droplet/airborne isolation precautions
* Participation in another clinical trial that interferes with the interpretation of the study results

Primary outcomes:
measure: The proportion of time spent in the target glucose range from 5.6 to 10.0 mmol/L based on sensor glucose levels during the time from hospital admission for elective surgery until discharge.
timeFrame: Up to 20 days
Secondary outcomes:
measure: Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
timeFrame: Up to 20 days
measure: Proportion of time spent with sensor glucose <3.0 mmol/L
timeFrame: Up to 20 days
measure: Average of sensor glucose level
timeFrame: Up to 20 days
measure: Time spent with sensor glucose below target (5.6 mmol/L)
timeFrame: Up to 20 days
measure: Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)
timeFrame: Up to 20 days
measure: Standard deviation and coefficient of variation of sensor glucose levels
timeFrame: Up to 20 days
measure: Total daily insulin requirements
timeFrame: Up to 20 days
Other outcomes:
measure: Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L)
timeFrame: Up to 20 days
measure: Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)
timeFrame: Up to 20 days
measure: Post-surgery comorbidity score as assessed using the Clavien Dindo Classification
timeFrame: Up to 20 days
measure: Length of hospital stay
timeFrame: Up to 20 days
measure: Proportion when closed-loop was active
timeFrame: Up to 20 days
Locations:
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
References:
citation: Herzig D, Suhner S, Roos J, Schurch D, Cecchini L, Nakas CT, Weiss S, Kadner A, Kocher GJ, Guensch DP, Wilinska ME, Raabe A, Siebenrock KA, Beldi G, Gloor B, Hovorka R, Vogt AP, Bally L. Perioperative Fully Closed-Loop Insulin Delivery in Patients Undergoing Elective Surgery: An Open-Label, Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):2076-2083. doi: 10.2337/dc22-0438.