ANODE01
Research type
Research Study
Full title
A single-centre, open-label study testing the safety and performance of the Glyconics-SX System in assessment of glycated nail keratin, compared with a standardised glycated haemoglobin (HbA1c) assay, in individuals with or without type 2 diabetes
IRAS ID
308393
Contact name
Pratik Choudhary
Contact email
Sponsor organisation
Glyconics
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 17 days
Research summary
Research Summary
Diabetes is a group of long term conditions that affect the ways in which our body uses food for energy. 1 in 10 adults live with diabetes around the world. 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 build up 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 which is often done during pregnancy. 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-SX system is in detecting the amount of glycated (sugar-coated) nail protein called keratin by shining a light into an individuals middle fingernail. the Infrared light is very similar to normal daylight. This low does of infrared light is partially absorbed in the nail and partially reflected back, and therefore, it is possible to use mathematical calculations to show how the reflections create different patterns. the pattern can be different for people with our without diabetes. The use of infrared light is called spectroscopy.
The research study will be conducted at The Leicester Diabetes Centre and will recruit up to 100 trial participants.
To be eligible to participate in this study, participants must be willing to undergo up to 30 measurements in both hands to measure NIR spectroscopy using the Glyconics-SX system in a clinic setting.
Summary of Results
Screening for diabetes is important for identification of people at risk of this serious health condition and its devastating complications. Finding those with undiagnosed diabetes by screening programmes is often costly and rather difficult, and therefore new ideas for more affordable and simplified screening are essential for prevention and more optimised management of diabetes. The main purpose of this clinical study was to test how good (how accurate) a new device called the Glyconics-SX System is for diabetes screening and how well it would identify people already living with Type 2 diabetes (T2D) or those without diabetes. This needle-free and rapid method identifies how much sugar has been absorbed into the nails over the last months, simply by shining infrared light onto a fingernail protein called keratin. The infrared light signal has been shown to be different among those with and without diabetes, and now Glyconics-SX was being tested against the known diabetes status and usual method of measurement of HbA1c by a finger-prick blood test. This was also import for confirmation if there were any previously unknown cases of diabetes. The study was conducted at the Leicester Diabetes Research Centre in the UK and involved one hundred (100) participants: half of them had previously been diagnosed with T2D while the other fifty (50) individuals had no previous diabetes diagnosis.
The participants who decided to join the study represented a diverse group of women and men of all age groups. Every person had a total of 60 rapid infrared readings of their middle fingernails (in both hands) over one to two minutes before the finger-prick test was performed. The device was very accurate in finding those who did not have diabetes: in more than 9 out of 10 cases (95.2%), the new device and fingernail analysis correctly identified the person who had no diabetes. This was confirmed against the results of the finger-prick test showing a blood sugar test result typical for a person without diabetes. No suspected new, previously undiagnosed cases were identified among the participants. None of the participants reported any safety -related concerns or sensations of pain or heat during the short infrared screening test procedure. The results were equally accurate and robust in all participants, i.e., age, sex, ethnicity or concomitant diseases or medications, smoking or dominance of the tested hand did not impact the results.
The results from this study confirm that new needle-free, rapid, and robust methods without single-use plastics or blood tests can be accurately and conveniently used for diabetes screening. The tested new method may help to use our limited healthcare resources in a smarter way as it is essential for any screening tool to find especially those who do not need further diagnostic testing.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: 15-Dec-2023
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: Results were shared by the following:-poster presentation P-963 at the American Diabetes Association 83rd Scientific Sessions on 23–26 June 2023: Pratik Choudhary; Daniela Lazaro-Pacheco; John E Salter; Päivi M Paldánius. Near-Infrared Device for Diabetes Screening: ANODE01 Study.
-associated press releases on Feb 4th (pre-announcement of having met primary endpoint) and June 24th, 2023 (with results) by Glyconics and associated distribution as below (examples):
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbeGuUT89a58xhpDv4wv-2Bx2ht6H5i29WdRidA-2F-2B-2BElPtcLgqLYwkn41CSVHE5N8Y-2Bi5V70-2BdPg2uj-2B0St0xzH-2B7vyKruGaCVgss9TPpA-2B9spFSlb-2FM0YQBJi3i3aJAR7PkydhI-2FiHx7rS1K3C2DDgQEorIhm2JgTkwliUDADyo5X8aNykOia8OWIs9rY5Q3f8PQ-3D-3DVOdq_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIoyXC8mKWiE4zVmeeUWoyJ8gShRZHB4syVfv2IrKHLzJSyLXIicFRtfec6mwLJLN3hWnbl09GTfgL7S5K0lBBqdUuw0MzFuQAxDBvYtEZA7zO1gxugqwNF6B4pB3AH4lV-2BBIjFWQZ0OVY6mnr56gHksy7qUdC5MXC1Tb24ibQsGg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cbda66252b67143b7b1b308dbd09e5075%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638333150599951017%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=2H9dTA6eK8j8WKlm2aD0ll0zag1PlnYMtbA0HLU4AL0%3D&reserved=0
-https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUJlRTm0WQiRFS5XJFz8-2FCjldnZRQpvniCM2SEoTsuCoZrDiHO3LA2fgEi4uTLqfEeJQumFqZWFQcrG5aewX4kT46DBhBI11NlLYnhzLis06tuD0TFh5-2FUHxfVVveruaLpMHQ2-2BMBx-2FsWWhmHpYOqR6RpRRWpyrAFltsu-2BOD5rFRAjFh_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIoyXC8mKWiE4zVmeeUWoyJrrebrDZ4ognR5D8l-2FtiLABZe2KoyF6ikXvu-2F9sSXrkEERy3qJsTyvMMdfIemdZseSxQzPD3a6od24016DL0psKibDRrWYFMnlsaIq-2B5zKE0q-2FLz8NphN82clG2FvnF1HB64wcjQfICERSe2wyRyxYw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cbda66252b67143b7b1b308dbd09e5075%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638333150599951017%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=5YwHyNMwg%2FmYvgz4VXFz4QtIfKjd2js9%2BirZn9eT51U%3D&reserved=0
-Oral presentation at European Association of Study of Diabetes on Oct 5th, 2023 (pooled data with an identical pilot study, ANODE02):
-X. Cos, D. Lazaro, J. Salter, P.M. Paldánius, P. Choudhary. Miniaturised near-infrared spectroscopy device in screening for diabetes-manuscript is under preparation (pooled data)
-clinicaltrial.gov: results will be summarized
The Clinical Investigation Report was submitted to MHRA and the Ethics Committee on 19Oct2023
REC name
South East Scotland REC 01
REC reference
22/SS/0022
Date of REC Opinion
14 Apr 2022
REC opinion
Further Information Favourable Opinion