Perioperative Closed-loop Glucose Control

Elective Surgery Clinical Trial

— POP-LOOP  

Official title:

Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361799
• Other study ID #: POP-LOOP
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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