Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06037551
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2023-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of system accuracy based on DIN EN ISO 15197', 'timeFrame': '1 Day', 'description': 'Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or female patients with hypo-, eu- or hyperglycaemia\n* The written informed consent had to be signed\n* The volunteers must be older than 18 years\n* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved\n\nExclusion criteria:\n\n* Pregnancy or lactation\n* Acute or chronic diseases with the risk of aggravation by the measure\n* A current constitution that does not allow participating in the study\n* Participation in another study or activity with the blood glucose measuring system evaluated in the present study\n* Application of substances listed in Appendix A of DIN EN ISO 15197:2015'}, 'identificationModule': {'nctId': 'NCT06037551', 'briefTitle': 'System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care', 'organization': {'class': 'OTHER', 'fullName': 'Institut fur Diabetes Karlsburg GmbH'}, 'officialTitle': 'Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia Diabetes Care Deutschland GmbH gemäß DIN EN ISO 15197:2015', 'orgStudyIdInfo': {'id': '2023_005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subject glucometer measurement', 'description': 'Blood glucose measurement BGM for personal use', 'interventionNames': ['Diagnostic Test: blood glucose measuremen subject', 'Diagnostic Test: blood glucose measuremen reference']}, {'type': 'EXPERIMENTAL', 'label': 'glucometer measurement', 'description': 'evaluation of repeatability measurement precision', 'interventionNames': ['Diagnostic Test: blood glucose measuremen reference']}], 'interventions': [{'name': 'blood glucose measuremen subject', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood', 'armGroupLabels': ['Subject glucometer measurement']}, {'name': 'blood glucose measuremen reference', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood', 'armGroupLabels': ['Subject glucometer measurement', 'glucometer measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17495', 'city': 'Karlsburg', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Institut für Diabetes Karlsburg GmbH', 'geoPoint': {'lat': 53.97172, 'lon': 13.61007}}], 'overallOfficials': [{'name': 'Kerstin Rebrin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut fur Diabetes Karlsburg GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'optional: age, blood glucose levels and hematocrit of subjects'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fur Diabetes Karlsburg GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}