Perioperative Closed-loop Glucose Control (POP-LOOP)

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Artificial Pancreas

Perioperative Hyperglycaemia

Elective Surgery

Insulin Therapy

Closed-Loop Glucose Control

Treatments

Device: CamAPS

Drug: Standard insulin therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04361799

POP-LOOP

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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