Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT05195567
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2022-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore
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': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-17', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', '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 based on procedures defined in DIN EN ISO 15197'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197', 'detailedDescription': 'This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients with clinical indication for blood glucose testing\n* Signed form of consent\n* Minimum age of 18 years\n* Subjects are legally competent and capable to understand character, meaning and consequences of the study\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Severe acute disease (at study physician's discretion)\n* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)\n* Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)\n* Being unable to give informed consent\n* Age younger than 18 years\n* Legally incompetent"}, 'identificationModule': {'nctId': 'NCT05195567', 'briefTitle': 'System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore', 'organization': {'class': 'OTHER', 'fullName': 'Institut fur Diabetes Karlsburg GmbH'}, 'officialTitle': 'Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.', 'orgStudyIdInfo': {'id': 'IDK_ISO_2021_007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subject glucometer measurement', 'interventionNames': ['Diagnostic Test: Glucometer Test', 'Diagnostic Test: blood glucose measurement, laboratory reference device']}], 'interventions': [{'name': 'Glucometer Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of the blood glucose concentration using the blood glucose monitor for personal use', 'armGroupLabels': ['Subject glucometer measurement']}, {'name': 'blood glucose measurement, laboratory reference device', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of the blood glucose concentration using a laboratory reference device', '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': 'Eckhard Salzsieder, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut fur Diabetes Karlsburg GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fur Diabetes Karlsburg GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beurer GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Eckhard Salzsieder, Director', 'investigatorFullName': 'Matthes Kenning', 'investigatorAffiliation': 'Institut fur Diabetes Karlsburg GmbH'}}}}