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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)

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
Continuous glucose monitoring
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Type 1 Diabetes focused on measuring Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Imperial College Clinical Research Facility

Outcomes

Primary Outcome Measures

%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)

Secondary Outcome Measures

%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)

Full Information

First Posted
September 6, 2023
Last Updated
September 6, 2023
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT06034574
Brief Title
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
Acronym
SuperComEx
Official Title
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
Study Type
Observational

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 with type 1 diabetes.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Exercise

7. Study Design

Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring
Intervention Description
Assessment of accuracy of two different continuous glucose monitoring devices during exercise
Primary Outcome Measure Information:
Title
%MARD lab phase
Description
To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (lab phase)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
%MARD home phase
Description
To assess % mean or median absolute relative difference (%MARD) of Supersapiens Abbott Libre Sense during exercise to reference capillary blood glucose (home phase)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Population Description
16 healthy volunteers undertaking regular physical activity 8 volunteers with type 1 diabetes undertaking regular physical activity
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Imperial College Clinical Research Facility
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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