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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04361799
Other study ID # POP-LOOP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2020
Est. completion date September 2, 2021

Study information

Verified date December 2021
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 2, 2021
Est. primary completion date September 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L) Safety outcome Up to 20 days
Other Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L) Safety outcome Up to 20 days
Other Post-surgery comorbidity score as assessed using the Clavien Dindo Classification The Clavien Dindo Classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The higher the grade, the higher the post-operative comorbidity burden. Up to 20 days
Other Length of hospital stay Up to 20 days
Other Proportion when closed-loop was active Utility outcome (will only be assessed in the closed-loop group) Up to 20 days
Primary 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. Up to 20 days
Secondary Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L) Up to 20 days
Secondary Proportion of time spent with sensor glucose <3.0 mmol/L Up to 20 days
Secondary Average of sensor glucose level Up to 20 days
Secondary Time spent with sensor glucose below target (5.6 mmol/L) Up to 20 days
Secondary Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L) Up to 20 days
Secondary Standard deviation and coefficient of variation of sensor glucose levels Up to 20 days
Secondary Total daily insulin requirements Up to 20 days
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