Method Comparison/User Evaluation of KEYA Smart Test System

• Research type

  Research Study

• Full title

  Performance Evaluation of KEYA Smart Blood glucose and ketone monitoring system

• IRAS ID

  201553

• Contact name

  Mills Leanne

• Contact email

  leanne.mills@inside-biometrics.com

• Sponsor organisation

  Inside Biometrics ltd

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  The aim of this study is to carry out a performance evaluation on the KEYA smart blood glucose and ketone monitoring system on capillary blood samples obtained from participants with Type 1 and Type 2 Diabetes. This will allow us to assess the technology in the target population and to obtain the data required for regulatory submission.

• REC name

  West of Scotland REC 4

• REC reference

  17/WS/0021

• Date of REC Opinion

  15 Mar 2017

• REC opinion

  Further Information Favourable Opinion