ANODE04
Research type
Research Study
Full title
A single centre, open-label clinical investigation confirming the safety and accuracy of the Glyconics-DS in assessment of glycated nail keratin in individuals with or without known T2DM: a confirmatory performance evaluation of the Glyconics SW package delivering the dichotomised screening test results in a known population
IRAS ID
359291
Contact name
Daniela Lazaro
Contact email
Sponsor organisation
Glyconics Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 20 days
Research summary
Diabetes is a group of long-term conditions that affect the way our body uses food for energy. Most diabetes is caused by either our bodies not being able to produce enough insulin or because our body is not able to use insulin efficiently. This can lead to the buildup of sugar in our body and over time could lead to heart, kidney problems, blindness and even death.
The blood sugar status of a person and the risk of diabetes can be determined in many ways. One test is known as the fasting or oral glucose (blood sugar) "tolerance" test. Another way is to measure how much of the haemoglobin attached to red blood cells has become sugar-coated. This is called glycated haemoglobin (HbA1c).
The study seeks to determine whether a new method called the Glyconics-DS system is effective in assessing the glycated (sugar-coated) nail protein called keratin by shining a light into an individual's fingernail. The infrared light is very similar to normal daylight. This low dose of infrared light is partially absorbed by the nail and partially reflected back; therefore, it is possible to use mathematical calculations to demonstrate how the reflections create different patterns. The pattern can be different for people with or without diabetes. The use of infrared light is called spectroscopy. The study seeks to confirm the accuracy of the Glyconics-DS system in detecting an individual's diabetes risk status, based on dichotomised results according to the selected chemometric model and using conventional HbA1c measurements as internal controls.
The research study will be conducted at QMUL and will recruit up to 100 trial participants.
To be eligible to participate in this study, participants must be willing to undergo a non-invasive glycation assessment on the nail using the Glyconics-DS system and a prick test.
REC name
North of Scotland Research Ethics Committee 2
REC reference
25/NS/0114
Date of REC Opinion
5 Nov 2025
REC opinion
Further Information Favourable Opinion