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.
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
24
Assessment of accuracy of two different continuous glucose monitoring devices during exercise
Imperial College Clinical Research Facility
London, United Kingdom
%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)
Time frame: 2 weeks
%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)
Time frame: 4 weeks
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