Safety and Performance of the Glyconics-SX System (ANODE02)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Near-infrared (NIR)
- Registration Number
- NCT05476016
- Lead Sponsor
- Glyconics Ltd
- Brief Summary
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with a validated comparator device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Apparently healthy adults (≥18 years of age) with known or unknown T2DM status 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 two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers
Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as
-
anaemia (iron deficiency sickle cell anaemia or similar)
-
haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
-
severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
-
severe Vitamin D deficiency
-
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
o Any structural, deviating and visually detectable deviations in the appearance of the nails potentially impacting the spectra measurement, including
-
nail dystrophy or deformity
-
severe nail infections (onychomycosis causing visual changes in the appearance of the nail)
-
rare hereditable conditions impacting the structure of keratin
-
mechanical damage or marks on the surface of the nail after removal of nail polish
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use of acrylic or gel nail decoration and polish, which cannot be removed o Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-label, single arm with identical intervention for all participants Near-infrared (NIR) Glycated keratin assessed by near-infrared and glycated haemoglobin (HbA1c) assessed based on finger prick blood drop sample
- Primary Outcome Measures
Name Time Method Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control) 60 seconds Overall probability of correct classification by the chemometric model output (yes / no DM)
- Secondary Outcome Measures
Name Time Method Assessment of sensitivity and specificity for chemometric model outcomes 60 seconds False positive and false negative assessments in %
Calculation of AUC with axis defined by false positive and negative rates for the model 60 seconds Area under curve
Calculation of negative and positive predictive value for the chemometric model 60 seconds Calculated values in %
Median (IQR) HbA1c values in both groups (with or without DM) 4 minutes HbA1c value in mmol/mol
Analysis of safety outcomes, included suspected de novo DM diagnosis based on HbA1c 15 minutes adverse events
Trial Locations
- Locations (1)
Sant Marti
🇪🇸Barcelona, Spain