Caraway System Accuracy

• Research type

  Research Study

• Full title

  Caraway System Accuracy Study for update to existing CE marked KEYA meter

• IRAS ID

  263307

• Contact name

  Jim Finlayson

• Contact email

  jim.finlayson@nhs.scot

• Sponsor organisation

  GlucoRx Technologies Ltd

• Duration of Study in the UK

  1 years, 0 months, 26 days

• Research summary

  The aim of this study is to carry out a Performance Evaluation Study on the Caraway Blood Glucose and Ketone Monitoring System. This study will be performed using capillary blood samples obtained from individuals with Type 1 or Type 2 Diabetes. This will allow us to assess the technology using the target population and to obtain regulatory submissions as well as aid the development of future test platforms. Each participant will donate a small volume of blood obtained via fingerstick, where a small needle is used to puncture the skin to obtain blood. The blood will be directly applied to test strips to determine the accuracy of the result. Blood will be collected in a microvette tube designed for capillary blood collection and 2 capillary tubes. Glucose, haematocrit and ketone measurements will be taken using reference laboratory equipment.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  22/YH/0286

• Date of REC Opinion

  12 Jan 2023

• REC opinion

  Further Information Favourable Opinion