Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes

Launched by GLYCONICS LTD · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new system called the Glyconics-DS to see how well it measures blood sugar levels. It looks at two ways to check sugar levels: one by examining a special marker in your fingernails and the other by a common blood test called HbA1c, which shows average blood sugar over the past few months. The goal is to confirm that this new method is safe and works well for both people with and without diabetes.

The study is open to adults who are 18 years or older and either know their diabetes status or don’t know if they have diabetes. To join, participants need to have at least one healthy fingernail without damage or nail polish that can’t be removed. During the study, participants will have their blood sugar checked using the new fingernail test and the standard finger prick blood test. Some people won’t be able to join, such as those with certain health conditions like severe anemia, kidney or liver problems, or those who recently donated blood. This study will take place at a single location and is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Apparently healthy adults (≥18 years of age) with known (n=50) or unknown T2DM status (n=50) willing to participate in and provide a written consent for the study
• • willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
• • Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail
• Exclusion Criteria:
• • Individuals with any known medical conditions impacting the PoC device assessment methodology for glycaemia, such as
• • Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar)
• • haemoglobinopathies or atypical haemoglobin subtypes not detectable by the assay
• • severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
• • severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 \< 25 nmol/ml)
• • known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia
• • eating disorders (as per clinical assessment)
• • recent (within 28 days) blood donation
• • known / diagnosed other diabetes such as T1DM, GDM, MODY, etc.
• * For the Glyconics-DS device / targeted nail:
• • Mechanical damage or marks on the surface of the nail after removal of nail polish, or
• • Use of acrylic or gel nail decoration and polish, which cannot be removed.