Libre Performance Check, version 1.0

• Research type

  Research Study

• Full title

  Performance Check of the Abbott FreeStyle Libre Flash Glucose Monitoring System

• IRAS ID

  161804

• Contact name

  Alistair Lumb

• Contact email

  Alistair.Lumb@ouh.nhs.uk

• Sponsor organisation

  Abbott Diabetes Care Ltd

• Research summary

  Multi-centre, prospective evaluation of the FreeStyle Libre Flash Glucose Monitoring System. Participants will use the device according to labelling instructions for a period of up to 14 days. Participants will return to the clinic on day 15 and the device data will be uploaded to the site PC. Two sensor lots tested per study. The study protocol may be conducted up to ten times (study events) per year on an ongoing basis. In addition to labelling requirements, participants will be asked to perform four fingerstick readings per day for each day of sensor wear using the built-in test strip port in the system. Ideally one before each meal and one before bed-time.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  14/WM/1136

• Date of REC Opinion

  17 Nov 2014

• REC opinion

  Further Information Favourable Opinion