Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-19 @ 2:47 AM
Study NCT ID:
NCT07039357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D013057', 'term': 'Spectrum Analysis'}], 'ancestors': [{'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient reported outcomes: test preference', 'timeFrame': '2 minutes', 'description': 'Rapid participant feedback based on preferred test methodology (Glyconics-DS vs PoC finger prick test), both cohort'}], 'primaryOutcomes': [{'measure': 'Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)', 'timeFrame': '10 minutes', 'description': 'Acceptance criteria for specificity is to demonstrate a result being at least or above 75%'}, {'measure': 'Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)', 'timeFrame': '10 minutes', 'description': 'Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%'}], 'secondaryOutcomes': [{'measure': 'Secondary performance measure and accuracy: False positive / negative rates for the screening test result', 'timeFrame': '10 minutes', 'description': 'Assessment of sensitivity and specificity -derived false positive / false negative rates in % for chemometric model outcomes for HbA1c cut-off value of 48 mmol/mol (6.5%) in the study cohort n=100, in individuals with and without known T2DM.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Healthy']}, 'descriptionModule': {'briefSummary': 'A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes'}, '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 (n=50) or unknown T2DM status (n=50) 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 at least one visually assessed undamaged, intact (preferably middle) fingernail\n\nExclusion Criteria:\n\n* Individuals with any known medical conditions impacting the PoC device assessment methodology for glycaemia, such as\n\n * Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar)\n * haemoglobinopathies or atypical haemoglobin subtypes not detectable by the assay\n * severe renal impairment (CKD stage III-IV) or decompensated hepatic disease\n * severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 \\< 25 nmol/ml)\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 * known / diagnosed other diabetes such as T1DM, GDM, MODY, etc.\n* For the Glyconics-DS device / targeted nail:\n\n * Mechanical damage or marks on the surface of the nail after removal of nail polish, or\n * Use of acrylic or gel nail decoration and polish, which cannot be removed.'}, 'identificationModule': {'nctId': 'NCT07039357', 'acronym': 'ANODE04', 'briefTitle': 'Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glyconics Ltd'}, 'officialTitle': 'A Single Centre, Open-label Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With or Without Known T2DM: a Confirmatory Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Screening Test Results in a Known Population.', 'orgStudyIdInfo': {'id': 'NIRDM-SXCIP04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apparently healthy volunteers without known diabetes', 'description': 'Both methods for assessment of glycaemia will be applied in this group as well', 'interventionNames': ['Device: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail']}, {'type': 'EXPERIMENTAL', 'label': 'People with known T2DM', 'description': 'Both methods for assessment of glycaemia will be applied in this group as well', 'interventionNames': ['Device: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail']}], 'interventions': [{'name': 'Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail', 'type': 'DEVICE', 'otherNames': ['HbA1c analysis by point-of-care device'], 'description': 'both interventions will be applied in both participant groups', 'armGroupLabels': ['Apparently healthy volunteers without known diabetes', 'People with known T2DM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'William Alazawi (prof)', 'role': 'CONTACT', 'email': 'BHNT.AIRS@nhs.net', 'phone': '+44 0207 767 3205'}], 'facility': 'Barts Liver Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The plan will be completed during the incoming weeks'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glyconics Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Queen Mary University of London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}