Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT06146933
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2023-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
System Accuracy of BGM GL22
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-09-07', 'studyFirstSubmitQcDate': '2023-11-24', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of system accuracy based on DIN EN ISO 15197', 'timeFrame': 'Day 1', 'description': 'Assessment of the analytical measurement performance of the blood glucose monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study assesses the system accuracy of a blood glucose monitoring system pursuant to ISO 15197'}, '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': 'NCT06146933', 'briefTitle': 'System Accuracy of BGM GL22', 'organization': {'class': 'OTHER', 'fullName': 'Institut fur Diabetes Karlsburg GmbH'}, 'officialTitle': 'Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL22 gemäß DIN EN ISO 15197:2015.', 'orgStudyIdInfo': {'id': '2023_004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subject glucometer measurement', 'interventionNames': ['Diagnostic Test: Glucometer Test', 'Diagnostic Test: Refernce Measurement']}], 'interventions': [{'name': 'Glucometer Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood glucose measurement using finger tip capillary blood using BGM', 'armGroupLabels': ['Subject glucometer measurement']}, {'name': 'Refernce Measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood glucose measurement using finger tip capillary blood using reference method', 'armGroupLabels': ['Subject 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': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fur Diabetes Karlsburg GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Kerstin Rebrin', 'investigatorFullName': 'Matthes Kenning', 'investigatorAffiliation': 'Institut fur Diabetes Karlsburg GmbH'}}}}