NCT06034574

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitoring	Assessment of accuracy of two different continuous glucose monitoring devices during exercise

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: United Kingdom