Proof of Concept Study for Non-Invasive BG Measurement System
Research type
Research Study
Full title
Proof of Concept Study to Undertake A Comprehensive Performance Evaluation of an Afon Technology Prototype Non-Invasive Blood Glucose Measurement System Compared to A Standard Measurement Method of Blood Glucose
IRAS ID
267119
Contact name
Isamar Carrillo Masso
Contact email
Sponsor organisation
Afon Technology, Ltd.
Clinicaltrials.gov Identifier
2019-002330-37, EUDRACT
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
This is an open, pilot, adaptive design study of prototype non-invasive glucometers under development by Afon Technology Ltd.
The study will be done in several iterative development phases. The initial sensor design will receive minor, safe, controlled changes for each iteration phase, and each design will be tested in a controlled clinical setting. In each Phase, Patients will be exposed to the prototype sensors on a minimum of 2 separate testing occasions to a maximum of 6 testing occasions per patient, to determine the device version with the best correlation between test readings and finger prick blood glucose measurements. While patients are connected to the device, they will be asked questions related to the usability and look of the final envisaged wearable glucometer.
A total of 10 development Phases are foreseen. Each Phase will study 5 patients with type 1 diabetes, and 5 patients with type 2 diabetes. Each patient will attend on two separate testing occasions.REC name
Wales REC 5
REC reference
19/WA/0367
Date of REC Opinion
20 Dec 2019
REC opinion
Favourable Opinion