In-House FreeStyle Libre, version A

• Research type

  Research Study

• Full title

  Sensor Accuracy Performance Review for FreeStyle Libre Glucose Monitoring Systems

• IRAS ID

  292446

• Contact name

  Elemer Balogh

• Contact email

  elemer.balogh@abbott.com

• Sponsor organisation

  Abbott Diabetes Care Ltd

• ISRCTN Number

  ISRCTN83594795

• Duration of Study in the UK

  10 years, 0 months, 0 days

• Research summary

  The purpose of this study is to estimate the performance of the FreeStyle Libre Flash Glucose Monitoring System and the FreeStyle Libre 3 Continuous Glucose Monitoring System compared to capillary blood glucose (BG) fingerprick results. The data is collected through a series of sub-studies (events) conducted
  on an ongoing basis.

  Participants will be asked to wear FreeStyle Libre Flash Glucose Monitoring Systems or FreeStyle Libre 3 Continuous Glucose Monitoring systems (or a mix of both) for up to 14 days. Each study event may
  vary slightly with respect to the number of days of wear (maximum 14), number of sensors worn concurrently (maximum of 4) and number of blood glucose tests per day (between 4 to 8).

  Abbott Diabetes Care employees and contractors would be eligible to enrol in the study. The study is being conducted at the ADC, Witney, UK only.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  21/WM/0064

• Date of REC Opinion

  12 Apr 2021

• REC opinion

  Further Information Favourable Opinion