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Perioperative Closed-loop Glucose Control (POP-LOOP)

Primary Purpose

Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CamAPS
Standard insulin therapy
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Hyperglycaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closed-loop insulin therapy

Standard insulin therapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Proportion of time spent with sensor glucose <3.0 mmol/L
Average of sensor glucose level
Time spent with sensor glucose below target (5.6 mmol/L)
Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)
Standard deviation and coefficient of variation of sensor glucose levels
Total daily insulin requirements

Full Information

First Posted
April 22, 2020
Last Updated
December 1, 2021
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04361799
Brief Title
Perioperative Closed-loop Glucose Control
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
September 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Hyperglycaemia, Insulin Therapy, Elective Surgery, Closed-Loop Glucose Control, Artificial Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop insulin therapy
Arm Type
Experimental
Arm Title
Standard insulin therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CamAPS
Intervention Description
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
Drug
Intervention Name(s)
Standard insulin therapy
Intervention Description
Standard insulin therapy according to local clinical practice.
Primary Outcome Measure Information:
Title
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.
Time Frame
Up to 20 days
Secondary Outcome Measure Information:
Title
Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L)
Time Frame
Up to 20 days
Title
Proportion of time spent with sensor glucose <3.0 mmol/L
Time Frame
Up to 20 days
Title
Average of sensor glucose level
Time Frame
Up to 20 days
Title
Time spent with sensor glucose below target (5.6 mmol/L)
Time Frame
Up to 20 days
Title
Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L)
Time Frame
Up to 20 days
Title
Standard deviation and coefficient of variation of sensor glucose levels
Time Frame
Up to 20 days
Title
Total daily insulin requirements
Time Frame
Up to 20 days
Other Pre-specified Outcome Measures:
Title
Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L)
Description
Safety outcome
Time Frame
Up to 20 days
Title
Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L)
Description
Safety outcome
Time Frame
Up to 20 days
Title
Post-surgery comorbidity score as assessed using the Clavien Dindo Classification
Description
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.
Time Frame
Up to 20 days
Title
Length of hospital stay
Time Frame
Up to 20 days
Title
Proportion when closed-loop was active
Description
Utility outcome (will only be assessed in the closed-loop group)
Time Frame
Up to 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lia Bally, MD PhD
Organizational Affiliation
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35880252
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.
Results Reference
derived

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Perioperative Closed-loop Glucose Control

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