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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 of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label, single arm with identical assessment of both biomarkers for all participants | Experimental | All participants will have their glycated nail keratin assessed by infrared and blood HbA1c levels measured via an assay (based on finger prick blood drop sample) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared (NIR) | Device | NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Overall probability of correct classification by the chemometric model output (yes / no DM) | 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of sensitivity and specificity for chemometric model outcomes | False positive and false negative assessments in % | 60 seconds |
| Calculation of negative and positive predictive value for the chemometric model |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as
Any structural, deviating and visually detectable deviations in the appearance of the nails potentially impacting the spectra measurement, including
Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
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| Name | Affiliation | Role |
|---|---|---|
| Paivi M Paldanius, MMed PhD | Glyconics Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester Diabetes Centre | Leicester | United Kingdom |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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Screening among individuals with or without known diabetes
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|
Calculated values in %
| 60 seconds |
| Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model | Area under the curve value | 60 seconds |
| Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device | HbA1c value in mmol/mol | 4 minutes |
| Analysis of safety outcomes (AEs, SAEs), including any safety outcomes listed in the comments, such as potential, suspected de novo diabetes diagnosis cases based on HbA1c readings | Adverse events | 15 minutes |
| D004700 | Endocrine System Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |