A Trial Investigating the Accuracy of Continuous Glucose Monitor Systems ("Supersapiens" Abbott Libre Sense and Dexcom G6) During Exercise in People With Normal Glucose Tolerance (SuperComEx)

September 6, 2023 updated by: Imperial College London
A two-phase, observational trial in an exercise laboratory and a prospective real-world setting to test the hypothesis that The Libre Sense Glucose Sport device has acceptable accuracy in people with normal glucose tolerance and comparable accuracy in the range of 3.0 to 11mmol/L to clinically approved CGM in people with type 1 diabetes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is two-phase trial including a research facility and home phase existing of five study related visits:

  • Screening visit and CPX test (2 hrs per visit)
  • three exercise sessions completed in a random order at the research facility (2 hrs per visit) plus an additional visit for people with normal glucose tolerance to undertake a glucose tolerance test
  • 4 weeks of home-based exercise (3 sessions of ~60 minutes moderate intensity exercise per week) - Including one glycaemic challenge prior to a single home-based exercise session
  • Final visit

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

16 healthy volunteers undertaking regular physical activity 8 volunteers with type 1 diabetes undertaking regular physical activity

Description

Inclusion Criteria:

  • • Male or female aged 18-65 years (both inclusive)

    • Body mass index 18.0-29.9 kg/m2 (both inclusive)
    • Normal glucose tolerance (measured via fasting blood glucose levels) or type 1 diabetes for greater than 1 year
    • Participants performing regular physical activity during the last 3 months prior to screening
    • Mass-specific peak oxygen consumption (VO2peak) >20 ml/kg/min

    • For participants with type 1 diabetes

      • Stable insulin regimen for 6 months
      • HbA1c ≤69mmol/mol

Exclusion Criteria:

  • • Enrolment in other study, except at the discretion of the Chief investigator

    • Known or suspected hypersensitivity to trial product(s) or related products
    • Receipt of any investigational medicinal product within 1 week prior to screening in this trial
    • Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not excluded patients how have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten-free diet.
    • Participant with a heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position)
    • Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives
    • Significant abnormal ECG at screening, as judged by the Investigator
    • Any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator might jeopardise participant's safety or compliance with the protocol
    • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
    • Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial
    • Potentially non-compliant or uncooperative during the trial, as judged by the Investigator
    • Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator
    • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%MARD lab phase
Time Frame: 2 weeks
To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (lab phase)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%MARD home phase
Time Frame: 4 weeks
To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (home phase)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21HH7234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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