Study to Evaluate a Prototype Non-Invasive BG Measurement System
Research type
Research Study
Full title
Development Study to Undertake a Comprehensive Performance Evaluation of Prototype Non-Invasive Blood Glucose Measurement Systems Compared to a Standard (Invasive) Measurement Method of Blood Glucose
IRAS ID
302010
Contact name
Stephen Bain
Contact email
Sponsor organisation
Afon Technology
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
1. Diabetes mellitus is a chronic disease currently affecting more than 425 million people, of which one-third are people older than 65 years. In the UK, the number of people currently diagnosed with diabetes surpassed 3.8 million in 2019, with someone being diagnosed with the illness every two minutes (Diabetes.org figures). The prototype device being tested is a non-invasive blood glucose measurement system worn on the wrist. This would help people with diabetes manage their condition better and help prevent complications.
2. The main objectives of the research are:
a. To determine how accurate and effective the Afon prototype non-invasive blood glucose measurement system (ATD) is, as compared to a gold standard invasive method.
b.To chart the Afon device's predicted blood glucose levels over time.
3. The study will be done with 30-50 patients. Eligible patients will have been diagnosed with diabetes (type 1 or 2) at least one year prior, be between 18 and 80 years old, and with a BMI between 18-35 kg/m2.
4. The trial will be conducted at the Joint Clinical Research Facility (JCRF), Institute of Life Science 2, Swansea University, SA2 8PP.
5. Participants will attend the site for a total of 5 visits, one for screening, and four study visits, no more than 7 days apart. The study will run for one year.REC name
West of Scotland REC 4
REC reference
21/WS/0139
Date of REC Opinion
31 Jan 2022
REC opinion
Further Information Favourable Opinion