User Evaluation of the FreeStyle Optium BG Monitoring system

• Research type

  Research Study

• Full title

  User Performance Evaluation of the FreeStyle Optium Blood Glucose Monitoring System

• IRAS ID

  184881

• Sponsor organisation

  Abbott Diabetes Care Ltd

• Duration of Study in the UK

  0 years, 1 months, 16 days

• Research summary

  This study compares blood glucose levels obtained on the FreeStyle Optium Blood Glucose Monitoring System with glucose measurements obtained on a laboratory analyser. The data collected during this study will be used to show if the product meets some new accuracy requirements.
  A target of 120 subjects at up to 2 study sites will be recruited. Participation in the study will consist of one visit to the study centre of a duration of approximately 30 minutes.
  After taking informed consent, participants will be asked to read the product labelling/instructions for use to familiarise themselves with the FreeStyle Optium Blood Glucose Monitoring System, perform practise tests if they require then perform one blood glucose test from their fingertip.
  After the participant has completed their test, the trained operator will collect approximately 150 µL (up to a maximum of 200 µL) of capillary blood from the participant’s fingertip to perform haemoglobin testing and YSI reference testing.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0395

• Date of REC Opinion

  23 Jun 2015

• REC opinion

  Favourable Opinion