MedDataX Logo

Perioperative Closed-loop Glucose Control

NCT ID: NCT04361799

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative Hyperglycaemia Insulin Therapy Elective Surgery Closed-Loop Glucose Control Artificial Pancreas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Closed-loop insulin therapy

Group Type EXPERIMENTAL

CamAPS

Intervention Type DEVICE

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 therapy

Group Type ACTIVE_COMPARATOR

Standard insulin therapy

Intervention Type DRUG

Standard insulin therapy according to local clinical practice.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CamAPS

Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.

Intervention Type DEVICE

Standard insulin therapy

Standard insulin therapy according to local clinical practice.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lia Bally, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Krutkyte G, Roos J, Schuerch D, Czerlau C, Wilinska ME, Wuethrich PY, Herzig D, Hovorka R, Vogt AP, Gloor B, Bally L. Fully Closed-Loop Insulin Delivery in Patients Undergoing Pancreatic Surgery. Diabetes Technol Ther. 2023 Mar;25(3):206-211. doi: 10.1089/dia.2022.0400. Epub 2022 Dec 14.

Reference Type DERIVED
PMID: 36449375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35880252 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

POP-LOOP

Identifier Type: -

Identifier Source: org_study_id