Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-16 @ 7:06 AM
Study NCT ID:
NCT03085251
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
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': 'D000085263', 'term': 'Self-Testing'}], 'ancestors': [{'id': 'D012648', 'term': 'Self Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System accuracy criteria', 'timeFrame': 'For each subject, the experimental phase has an expected duration of up to 6 hours', 'description': 'Based on EN ISO 15197:2015 (ISO 15197:2013) (E), the BGMS shall meet both of the following criteria:\n\nCriterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \\< 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).\n\nEach lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, with type 1 diabetes, type 2 diabetes (or subjects without diabetes)\n* Signed informed consent form\n* Minimum age of 18 years\n* Subjects are legally competent and capable to understand character, meaning and consequences of the study.\n* If blood glucose values \\< 80 mg/dl or \\> 300 mg/dl shall be measured after short term alteration in insulin therapy:\n* Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.\n* Signature of subjects to document consent with these procedures on informed consent form.\n\nExclusion Criteria:\n\n* Pregnancy or lactation period\n* Severe acute disease (at the study physician's discretion)\n* Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)\n* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)\n* Being unable to give informed consent\n* \\< 18 years\n* Legally incompetent\n* Being committed to an institution (e.g. psychiatric clinic)\n* Language barriers potentially compromising an adequate compliance with study procedures\n* Dependent on investigator or sponsor\n* If blood glucose values \\< 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2), subjects with type 1 diabetes, suffering from:\n* Coronary heart disease\n* Condition after myocardial infarction\n* Condition after cerebral events\n* Peripheral arterial occlusive disease\n* Hypoglycemia unawareness"}, 'identificationModule': {'nctId': 'NCT03085251', 'briefTitle': 'Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)', 'organization': {'class': 'OTHER', 'fullName': 'Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm'}, 'officialTitle': 'Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)', 'orgStudyIdInfo': {'id': 'IDT-1653-LI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood glucose measurement', 'interventionNames': ['Device: Blood glucose monitoring systems for self-testing (BGMS)']}], 'interventions': [{'name': 'Blood glucose monitoring systems for self-testing (BGMS)', 'type': 'DEVICE', 'otherNames': ['OneTouch® Verio Flex'], 'description': "Measurement procedure\n\n* Subjects will be asked to wash and dry their hands before the measurements.\n* The measurement procedure for each reagent system lot of a BGMS will be as follows:\n* Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture.\n* Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package.\n* Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture.\n* The sample will be applied to the reagent system units following specifications in the manufacturer's labelling.", 'armGroupLabels': ['Blood glucose measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm', 'class': 'OTHER'}, 'collaborators': [{'name': 'LifeScan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}