Glyconics-SX is a point-of-care device developed by UK medtech company Glyconics. The system exploits miniaturised near-infrared (NIR) spectrometry and cloud-based algorithm. The handheld device detects biomarker changes (glycated, ‘sugar-coated’, keratin) based on a few infrared scans of a person’s fingernail within seconds.
The company’s chief medical officer, Dr. Päivi Maria Paldánius, said the test result reflects exposure to long term (weeks and months of) normal or elevated blood sugar levels and can be used as an indicator of risk of diabetes.
“However, confirmatory diagnostic testing for categorisation of diabetes is necessary in individuals with chronic elevated blood glucose levels – a ‘positive’ result,” said Dr Paldánius. “A ‘negative’ screening test result, indicative of no immediate risk of diabetes due to currently normal sugar levels, directs the use of limited healthcare resources to those at risk.”
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Glyconics-SX has been put through its paces in the so-called clinical ANODE diabetes programme, which ran from July 2022 to November and tested the safety and accuracy of NIR methodology in two independent studies, ANODE01 and ANODE02, conducted in Leicester and Barcelona respectively.
According to Glyconics, each study involved 100 individuals with or without known type 2 diabetes, and assessment of their diabetes risk and status was based on a total of 12,000 NIR spectral scans of the participants’ middle fingernails on both hands.
Dr Paldánius added that more people die prematurely from diabetes than breast cancer and prostate cancer every year. It is also a major cause of debilitating conditions including blindness, heart attack and stroke.
“Although early detection is recommended, mass-screening for diabetes is not implemented as it currently necessitates invasive blood sampling, tons of single-use plastics and complex, costly operations,” she said.
The currently embargoed ANODE01 and ANODE02 diabetes programme results will be formally announced at the annual meeting of the American Diabetes Association (ADA) in June, 2023.
“The clinical implementation of these results - using a novel, non-invasive approach to screening – will now enable a more strategic allocation of limited healthcare resources for the management of global diabetes risk in the future,” said Dr Paldánius.
Glyconics said it will continue it clinical programme with a third large-scale ANODE03 study later this year.
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