Labelling Comprehension Study

• Research type

  Research Study

• Full title

  Labelling Comprehension Study for a blood glucose and ketone monitoring system

• IRAS ID

  278247

• Contact name

  Jim Finlayson

• Contact email

  jim.finlayson@nhs.scot

• Sponsor organisation

  GlucoRx Technologies Ltd.

• Duration of Study in the UK

  0 years, 9 months, 0 days

• Research summary

  The aim of this study is to determine the comprehension of the Instructions for use (IFU) of the KEYA Smart test system (Caraway) by users who are both familiar and unfamiliar with blood glucose monitoring test systems.

  This study will require 15 participants who have been diagnosed with Type 1 or Type 2 Diabetes, 16 year or older who are familiar (already use) and unfamiliar (have never used or newly diagnosed) blood glucose monitoring test systems.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  23/NW/0041

• Date of REC Opinion

  15 Feb 2023

• REC opinion

  Further Information Favourable Opinion