Clinical Evaluation of IBL Blood Analyte Monitoring Systems
Research type
Research Study
Full title
Clinical Evaluation of Inside Biometrics Blood Analyte Monitoring Systems
IRAS ID
179148
Contact name
Selly Saini
Contact email
Sponsor organisation
Inside Biometrics Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 12 days
Research summary
The aim of this study is to investigate Inside Biometrics' blood analyte monitoring test systems 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 the products for regulatory submission as well as aid the development of future test platforms. The study will recruit a minimum of 350 participants with diabetes from specialist and primary care diabetes clinics. Each participant will donate a small volume of blood obtained via a 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 into 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
West of Scotland REC 4
REC reference
15/WS/0105
Date of REC Opinion
14 Jul 2015
REC opinion
Further Information Favourable Opinion