AzTrials
AzTrials

Type 1 DiabetesSuperComExNCT06034574

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

An observational study of Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
Continuous glucose monitoring
Type of treatment
Medical device
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2023to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • • 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

Who cannot join

  • • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College Clinical Research Facility

    London

Other trials in United Kingdom

About this study

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.

Read the 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
Conditions
Type 1 Diabetes
Being tested
Continuous glucose monitoring
Keywords
Exercise
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous glucose monitoringDevice

    Assessment of accuracy of two different continuous glucose monitoring devices during exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. %MARD lab phase

    To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (lab phase)

    Measured: 2 weeks

Secondary outcomes (1)

  1. %MARD home phase

    To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (home phase)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034574
Sponsor's protocol ID
21HH7234
Acronym
SuperComEx
Status last verified
Sep 2023
First submitted
6 Sep 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

%MARD lab phase (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06034574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in