Masked FreeStyle Libre Performance Check

• Research type

  Research Study

• Full title

  Masked Performance Check of the Abbott FreeStyle Libre Flash Glucose Monitoring System

• IRAS ID

  178494

• Contact name

  Alistair Lumb

• Sponsor organisation

  Abbott Diabetes Care Ltd.

• Duration of Study in the UK

  10 years, 0 months, 0 days

• Research summary

  Multi-centre, prospective evaluation of the masked FreeStyle Libre Flash Glucose Monitoring System. Participants will use the device according to labelling instructions for a period of up to 14 days but will not be able to see any Sensor glucose data. Participants will return to the clinic on day 15 and the device data will be uploaded to the site PC. Up to three Sensor lots will be tested per study. The study protocol may be conducted up to twelve times (study events) per year on an ongoing basis. Participants will be asked to perform at least 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.
  In addition, participants will be provided with an option of wearing a second FreeStyle Libre Sensor for the same period of up to 14 days (simultaneous wear). This second FreeStyle Libre Sensor will be an ‘off the shelf’ product and a different Sensor lot to that of the masked Sensor, participants will be able to see Sensor glucose data and use this system according to labelling instructions. This second FreeStyle Libre Sensor wear is entirely optional.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  15/NW/0267

• Date of REC Opinion

  20 Mar 2015

• REC opinion

  Favourable Opinion