Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-23 @ 4:32 AM
Study NCT ID:
NCT00985257
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2009-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance of a New Glucose Meter System in Children and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carmine.greene@ascensia.com', 'phone': '574-257-3040', 'title': 'Carmine Greene, Senior Clinical Research Scientist', 'organization': 'Ascensia Diabetes Care'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Subjects With Diabetes', 'description': 'Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.', 'otherNumAtRisk': 123, 'otherNumAffected': 0, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}, {'units': 'capillary blood glucose results', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Diabetes', 'description': 'Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.'}], 'classes': [{'title': 'Subject Tests Natural Capillary n=242=2 x 121', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000'}]}]}, {'title': 'Combine Natural+Modified n=336=2 x (121+47)', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-2 hours', 'description': 'Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \\<75mg/dL) or +/- 20% (for reference BG values \\>/=75mg/dL) of the reference method results.', 'unitOfMeasure': 'percent of blood glucose results', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'capillary blood glucose results', 'denomUnitsSelected': 'Participants', 'populationDescription': 'To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.', 'anticipatedPostingDate': '2010-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects With Diabetes', 'description': 'Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects With Diabetes', 'description': 'Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 4-12 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': 'Age 13 to 17 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Age 18 to 24 years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2009-09-24', 'resultsFirstSubmitDate': '2010-04-06', 'studyFirstSubmitQcDate': '2009-09-25', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-10-07', 'studyFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method', 'timeFrame': '1-2 hours', 'description': 'Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \\<75mg/dL) or +/- 20% (for reference BG values \\>/=75mg/dL) of the reference method results.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 or Type 2 diabetes\n* Age 4 to 24 years\n* Routinely performs blood glucose testing at home\n* If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.\n* If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.\n* Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate\n\nExclusion Criteria:\n\n* Currently pregnant\n* Hemophilia or any other bleeding disorder\n* Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded\n* Infection with a blood borne pathogen (e.g., HIV, hepatitis)\n* Subject or parent/guardian is employee of competitive medical device company\n* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study"}, 'identificationModule': {'nctId': 'NCT00985257', 'briefTitle': 'Performance of a New Glucose Meter System in Children and Young Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults', 'orgStudyIdInfo': {'id': 'CTD-2009-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subjects with diabetes', 'description': 'Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.', 'interventionNames': ['Device: DIDGET (Investigational Blood Glucose Monitoring System)']}], 'interventions': [{'name': 'DIDGET (Investigational Blood Glucose Monitoring System)', 'type': 'DEVICE', 'description': "Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.", 'armGroupLabels': ['Subjects with diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Larry C. Deeb, MD PA', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'overallOfficials': [{'name': 'Timothy Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCR Institute'}, {'name': 'Larry C Deeb, MD PA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larry C. Deeb, MD PA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}