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Completed

NCT Number: NCT04361799

Perioperative Closed-loop Glucose Control

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CamAPS

Device

Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.

Standard insulin therapy

Drug

Standard insulin therapy according to local clinical practice.

Primary outcomes

  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 outcomes

  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

Other outcomes

  1. Number of severe hypoglycaemic episodes (plasma glucose <2.2 mmol/L)

    Time frame: Up to 20 days

    Safety outcome

  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

    Safety outcome

  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

    Utility outcome (will only be assessed in the closed-loop group)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: POP-LOOP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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