PHT2D Trial
Research type
Research Study
Full title
Intermediate Type 2 Diabetes Glucose and Diary Trial
IRAS ID
292431
Contact name
Michael Cummings
Contact email
Sponsor organisation
Bioepic Ltd
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The key to managing and living well with diabetes involves early diagnosis and monitoring of glucose control. Traditional self-monitoring of blood glucose (SMBG) via finger-prick testing can help patients to maintain their glucose levels within the appropriate range. However, we know each SMBG test requires a single-use test strip and lancet, conferring a significant economic burden for healthcare systems and patients. Additionally, discomfort of SMBG can result in reduced compliance with monitoring.
A non-invasive glucose monitoring device (NIGMD) has the potential to achieve efficiency savings and can reduce physical psychological barriers to testing.
The Bioepic Glucose Monitoring System is a NIGDM that utilises a video trace of blood flow in the user’s fingertip (recorded by a smartphone camera) to quantify certain aspects of the user’s pulse and uses artificial intelligence (AI) to predict the blood glucose level. This AI has been trained using SMBG measurements from individuals with and without diabetes.
The purpose of this study is to test the AI predicted blood glucose level derived from the Bioepic system in individuals with non-insulin treated Type 2 Diabetes and compare the readings with those from SMBG. The Bioepic system glucose reading is recorded via a pre-downloaded App on a smartphone, by placing a fingertip over the smartphone camera lens for 30 seconds. An SMBG reading is also recorded to create a ‘matched pair’. Participants will not have access to the glucose value recorded by the App.
The study would be undertaken in two parts. The first part would involve participants recording matched pairs at home over a 30-day period. The second part of the study would involve participants taking matched pair samples at a study site before and after a set carbohydrate meal. These matched pairs will be compared to assess the accuracy of the Bioepic system against accepted standards.REC name
London - South East Research Ethics Committee
REC reference
21/LO/0055
Date of REC Opinion
2 Feb 2021
REC opinion
Unfavourable Opinion