SuperComEx

• Research type

  Research Study

• Full 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(SuperComEx)

• IRAS ID

  303611

• Contact name

  Neil Hill

• Contact email

  neil.hill@nhs.net

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  Supersapiens Abbott Libre Sense is a device that measures interstitial glucose levels marketed for use by people with normal glucose tolerance who undertake physical exercise. Initially this device was invented for monitoring glucose in people with type 1 diabetes. This version is intended for those without diabetes, however, given its availability and reduced price compared to other continuous glucose monitors, it may be attractive to people living with diabetes, especially those who regularly exercise. Accuracy of the device has not been reported in free living or laboratory conditions and has not been assessed during physical exercise. Furthermore, the applicability in individuals without diabetes has not been assessed yet.
  Therefore, the aim of this study is to assess the accuracy of the Supersapiens Abbott Libre Sense device in people with normal glucose tolerance and those with type 1 diabetes, and to compare it to reference blood glucose values and with the accuracy of another CGM system which is licensed for use by people with diabetes under exercise and resting conditions.
  The proposed study will recruit 16 healthy participants and 8 participants with type 1 diabetes to a two-phase trial including a research facility and home phase existing of five study related visits:
  • Screening visit including cardio-pulmonary exercise (CPX) test and installation of glucose sensors
  • three exercise sessions at the research facility, completed in a random order
  o continuous moderate intensity exercise test
  o high-intensity-interval exercise test
  o resistance exercise test
  • an additional visit to undertake a glucose tolerance test for participants with normal glucose metabolism
  • 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
  

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  22/SC/0006

• Date of REC Opinion

  22 Feb 2022

• REC opinion

  Further Information Favourable Opinion