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Perioperative Closed-loop Glucose Control (POP-LOOP)

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ClinicalTrials.gov Identifier: NCT04361799
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE April 22, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date April 28, 2020
Estimated Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
  • Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L) [ Time Frame: Up to 20 days ]
  • Proportion of time spent with sensor glucose <3.0 mmol/L [ Time Frame: Up to 20 days ]
  • Average of sensor glucose level [ Time Frame: Up to 20 days ]
  • Time spent with sensor glucose below target (5.6 mmol/L) [ Time Frame: Up to 20 days ]
  • Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L) [ Time Frame: Up to 20 days ]
  • Standard deviation and coefficient of variation of sensor glucose levels [ Time Frame: Up to 20 days ]
  • Total daily insulin requirements [ Time Frame: Up to 20 days ]
  • Daily time spent on diabetes management [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2020)
  • Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L) [ Time Frame: Up to 20 days ]
  • Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L) [ Time Frame: Up to 20 days ]
  • Post-surgery comorbidity score as assessed using the Clavien Dindo Classification [ Time Frame: Up to 20 days ]
    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.
  • Length of hospital stay [ Time Frame: Up to 20 days ]
  • Proportion when closed-loop was active [ Time Frame: Up to 20 days ]
Original Other Pre-specified Outcome Measures
 (submitted: April 22, 2020)
  • Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L) [ Time Frame: Up to 20 days ]
  • Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L) [ Time Frame: Up to 20 days ]
  • Post-surgery comorbidity score as assessed using the Clavien Dindo Classification [ Time Frame: Up to 20 days ]
  • Length of hospital stay [ Time Frame: Up to 20 days ]
  • Proportion when closed-loop was active [ Time Frame: Up to 20 days ]
 
Descriptive Information
Brief Title  ICMJE Perioperative Closed-loop Glucose Control
Official Title  ICMJE Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Perioperative Hyperglycaemia
  • Insulin Therapy
  • Elective Surgery
  • Closed-Loop Glucose Control
  • Artificial Pancreas
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Closed-loop insulin therapy
    Intervention: Device: CamAPS
  • Active Comparator: Standard insulin therapy
    Intervention: Drug: Standard insulin therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lia Bally, MD PhD +41 31 632 40 70 lia.bally@insel.ch
Contact: Andreas Vogt, MD andreas.vogt@insel.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04361799
Other Study ID Numbers  ICMJE POP-LOOP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lia Bally, MD PhD Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
PRS Account University Hospital Inselspital, Berne
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP