Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00202033
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'blood glucose testing frequency', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['referred to', 'comprehensive', 'diabetes', 'education', 'program'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'To determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the HbA1c level.', 'detailedDescription': 'To determine the impact of SMBG frequency on blood glucose control in patients receiving systematic diabetes management education through Type 2 Diabetes BASICS at International Diabetes Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Treatment with diet and exercise alone or with the addition of 1 or 2 oral agents\n* Enrolled in Type 2 BASICS program\n* A1c between 7.0 and 11%, inclusive\n* Able to understand spoken English\n\nExclusion Criteria:\n\n* Insulin therapy\n* Unable/unwilling to perform SMBG\n* Participating in another research study\n* Currently performing SMBG \\>3 times/week'}, 'identificationModule': {'nctId': 'NCT00202033', 'briefTitle': 'Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '01856-04-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'self monitor blood glucose 3 times a day per usual diabetes class curriculum', 'interventionNames': ['Behavioral: frequency of self monitoring blood glucose']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'only self monitor blood glucose when fasting', 'interventionNames': ['Behavioral: frequency of self monitoring blood glucose']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'no self monitoring of blood glucose', 'interventionNames': ['Behavioral: frequency of self monitoring blood glucose']}], 'interventions': [{'name': 'frequency of self monitoring blood glucose', 'type': 'BEHAVIORAL', 'description': 'Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'International Diabetes Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Richard M Bergenstal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Park Nicollet Institute/International Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Diabetes Center at Park Nicollet', 'class': 'OTHER'}, {'name': 'LifeScan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}