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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05476016
Recruitment Status : Completed
First Posted : July 27, 2022
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Glyconics Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Near-infrared (NIR) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Screening among individuals with or without known diabetes
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Single-Centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
Actual Study Start Date : August 29, 2022
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : December 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: Near-infrared (NIR)
NIR spectral assessment of glycated nail keratin vs HbA1c
Other Name: point-of-care device (HbA1c analyser)


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: 60 seconds ]
    Overall probability of correct classification by the chemometric model output (yes / no DM)


Secondary Outcome Measures :
  1. Assessment of sensitivity and specificity for chemometric model outcomes [ Time Frame: 60 seconds ]
    False positive and false negative assessments in %

  2. Calculation of negative and positive predictive value for the chemometric model [ Time Frame: 60 seconds ]
    Calculated values in %

  3. Calculation of AUC with axis defined by false positive and negative rates for the model [ Time Frame: 60 seconds ]
    Area under curve

  4. Median (IQR) HbA1c values in both groups (with or without DM) [ Time Frame: 4 minutes ]
    HbA1c value in mmol/mol

  5. Analysis of safety outcomes, included suspected de novo DM diagnosis based on HbA1c [ Time Frame: 15 minutes ]
    adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05476016


Locations
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Spain
Sant Marti
Barcelona, Spain
Sponsors and Collaborators
Glyconics Ltd
More Information
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Responsible Party: Glyconics Ltd
ClinicalTrials.gov Identifier: NCT05476016    
Other Study ID Numbers: NIRDM-SXCIP02
First Posted: July 27, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases