Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-29 @ 9:09 PM
Study NCT ID:
NCT05198895
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance of the Glyconics-SX System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Screening among individuals with or without known diabetes'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': '60 seconds', 'description': 'Overall probability of correct classification by the chemometric model output (yes / no DM)'}], 'secondaryOutcomes': [{'measure': 'Assessment of sensitivity and specificity for chemometric model outcomes', 'timeFrame': '60 seconds', 'description': 'False positive and false negative assessments in %'}, {'measure': 'Calculation of negative and positive predictive value for the chemometric model', 'timeFrame': '60 seconds', 'description': 'Calculated values in %'}, {'measure': 'Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model', 'timeFrame': '60 seconds', 'description': 'Area under the curve value'}, {'measure': 'Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device', 'timeFrame': '4 minutes', 'description': 'HbA1c value in mmol/mol'}, {'measure': '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', 'timeFrame': '15 minutes', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test\n* Individuals with two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers\n\nExclusion Criteria:\n\n* Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as\n\n * anaemia (iron deficiency sickle cell anaemia or similar)\n * haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,\n * severe renal impairment (CKD stage III-IV) or decompensated hepatic disease\n * severe Vitamin D deficiency\n * known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia\n * eating disorders (as per clinical assessment)\n * Recent (within 28 days) blood donation\n* Any structural, deviating and visually detectable deviations in the appearance of the nails potentially impacting the spectra measurement, including\n\n * nail dystrophy or deformity\n * severe nail infections (onychomycosis causing visual changes in the appearance of the nail)\n * rare hereditable conditions impacting the structure of keratin\n * mechanical damage or marks on the surface of the nail after removal of nail polish\n * use of acrylic or gel nail decoration and polish, which cannot be removed\n* Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.'}, 'identificationModule': {'nctId': 'NCT05198895', 'acronym': 'ANODE01', 'briefTitle': 'Safety and Performance of the Glyconics-SX System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glyconics Ltd'}, 'officialTitle': 'A Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NIRDM-SXCIP01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label, single arm with identical assessment of both biomarkers for all participants', 'description': '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)', 'interventionNames': ['Device: Near-infrared (NIR)']}], 'interventions': [{'name': 'Near-infrared (NIR)', 'type': 'DEVICE', 'otherNames': ['point-of-care device (HbA1c analyser)'], 'description': 'NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)', 'armGroupLabels': ['Open-label, single arm with identical assessment of both biomarkers for all participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Diabetes Centre', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Paivi M Paldanius, MMed PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glyconics Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glyconics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}