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Perioperative Closed-loop Glucose Control (POP-LOOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Perioperative Hyperglycaemia Insulin Therapy Elective Surgery Closed-Loop Glucose Control Artificial Pancreas Device: CamAPS Drug: Standard insulin therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Closed-loop Insulin Delivery Versus Standard Insulin Therapy - a Randomised Controlled Parallel Clinical Trial in Adults With Type 2 Diabetes
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Closed-loop insulin therapy 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.

Active Comparator: Standard insulin therapy Drug: Standard insulin therapy
Standard insulin therapy according to local clinical practice.




Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of time spent with sensor glucose values above target (> 10.0 mmol/L) [ Time Frame: Up to 20 days ]
  2. Proportion of time spent with sensor glucose <3.0 mmol/L [ Time Frame: Up to 20 days ]
  3. Average of sensor glucose level [ Time Frame: Up to 20 days ]
  4. Time spent with sensor glucose below target (5.6 mmol/L) [ Time Frame: Up to 20 days ]
  5. Proportion of time spent with sensor glucose levels in significant hyperglycaemia (glucose levels > 20 mmol/L) [ Time Frame: Up to 20 days ]
  6. Standard deviation and coefficient of variation of sensor glucose levels [ Time Frame: Up to 20 days ]
  7. Total daily insulin requirements [ Time Frame: Up to 20 days ]
  8. Daily time spent on diabetes management [ Time Frame: 24 hours ]

Other Outcome Measures:
  1. Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L) [ Time Frame: Up to 20 days ]
  2. Number of clinically significant hyperglycaemic events (>20.0 mmol/L) with ketonaemia (beta-hydroxybutyrate >1.0 mmol/L) [ Time Frame: Up to 20 days ]
  3. 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.

  4. Length of hospital stay [ Time Frame: Up to 20 days ]
  5. Proportion when closed-loop was active [ Time Frame: Up to 20 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361799


Contacts
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Contact: Lia Bally, MD PhD +41 31 632 40 70 lia.bally@insel.ch
Contact: Andreas Vogt, MD andreas.vogt@insel.ch

Locations
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Switzerland
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lia Bally, MD PhD Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University, Unviersity of Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04361799    
Other Study ID Numbers: POP-LOOP
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs