DEFINE_Dexcom

  • Research type

    Research Study

  • Full title

    A Trial Investigating the Performance of the Dexcom G6® Real-time Continuous Glucose Monitoring (rtCGM) System in a Head-to-head Comparison with the FreeStyle® Libre 2 Intermittently Viewed Continuous Glucose Monitoring (iCGM) System around High-Intensity Interval Exercise and Moderate-Intensity Continuous Exercise in Individuals with Type 1 Diabetes

  • IRAS ID

    274113

  • Contact name

    Richard Bracken

  • Contact email

    r.m.bracken@swansea.ac.uk

  • Sponsor organisation

    Swansea University

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT00000000

  • Duration of Study in the UK

    1 years, 0 months, 2 days

  • Research summary

    It is currently not known how Dexcom G6® and FreeStyle® Libre 2 perform around different types of exercise and different glucose ranges. An initial question would be to compare the performance of the Dexcom G6® and FreeStyle® Libre 2 to EKF references values during exercise. This information would be crucial for people with type 1 diabetes (T1D) and their healthcare providers when they strive to increase physical activity. In light of this, this study would aim to examine the accuracy in comparison of Dexcom G6® and FreeStyle® Libre 2 to EKF references values before, during and after high-intensity interval exercise (HIIE) and continuous exercise (CE) and different glucose ranges in individuals with T1D.
    The null hypothesis is that there will be no differences in exercise-induced changes in glucose levels in comparison of Dexcom G6® and FreeStyle® Libre 2 to EKF references values before, during, and after HIIE and CE exercises and different glycaemic ranges.
    Adults with type 1 diabetes on multiple daily injections will be invited for trial visits at a clinical research facility in Swansea University. The participants will attend 4 visits; screening for eligibility, 2 experimental visits with 90 mins of HIIE or CE and regular blood samples, and a follow-up visit.

  • REC name

    Wales REC 6

  • REC reference

    20/WA/0004

  • Date of REC Opinion

    13 Feb 2020

  • REC opinion

    Further Information Favourable Opinion