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

NCT06034574 | Unknown

• 1 other identifier: 21HH7234
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Exercise

Outcome Measures

Primary Outcomes (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)

  2 weeks

Secondary Outcomes (1)

• %MARD home phase

  4 weeks

Interventions

Continuous glucose monitoring DEVICE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Clinical Research Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)