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Safety and Performance of the Glyconics-SX System (ANODE02)

NCT ID: NCT05476016

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2022-12-08

Brief Summary

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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 and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with a validated comparator device.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Screening among individuals with or without known diabetes
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Open-label, single arm with identical intervention for all participants

Glycated keratin assessed by near-infrared and glycated haemoglobin (HbA1c) assessed based on finger prick blood drop sample

Group Type EXPERIMENTAL

Near-infrared (NIR)

Intervention Type DEVICE

NIR spectral assessment of glycated nail keratin vs HbA1c

Interventions

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Near-infrared (NIR)

NIR spectral assessment of glycated nail keratin vs HbA1c

Intervention Type DEVICE

Other Intervention Names

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point-of-care device (HbA1c analyser)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glyconics Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sant Marti

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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NIRDM-SXCIP02

Identifier Type: -

Identifier Source: org_study_id