Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT00824603
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Continuing Medical Education (CME) Insulin Program
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2009-01-15', 'studyFirstSubmitQcDate': '2009-01-16', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program.", 'timeFrame': 'pre program survey & 2-4 month post program survey'}], 'secondaryOutcomes': [{'measure': "pre-CME training level of patient's A1c when starting insulin therapy compared to post-CME training level of patient's A1c when starting insulin therapy", 'timeFrame': 'pre program survey and 2-4 month post program survey'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if a continuing medical education (CME) program can change primary care providers' use of insulin therapy - their confidence in selecting doses and engagement of patients in the decision making as to whether to initiate insulin therapy.", 'detailedDescription': "We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program. Specifically, we will address the following questions:\n\nQuestion 1. Clinical guidelines. Is insulin initiated earlier (at a lower A1C)?\n\nQuestion 2. Decision-making. Does confidence in selecting a starting insulin regimen change? Does confidence in selecting a starting insulin dose change? Does confidence in adjusting insulin change? Does confidence in discussion nutrition guidelines change?\n\nQuestion 3. Application. Do more patients start using insulin? Who usually selects starting dose? How is starting dose selected? How often is insulin adjusted?\n\nQuestion 4. Resources. How available are protocols for insulin use? How available is adequate time to monitor insulin therapy? How available is staff to teach insulin injections? How available is staff to help adjust insulin?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care providers affiliated with the participating healthcare organizations were invited to attend.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary care provider attending CME training\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00824603', 'briefTitle': 'Impact of Continuing Medical Education (CME) Insulin Program', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Impact of CME Program on Self-Reported Confidence and Use of Insulin in Persons With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '03425-06-C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'primary care provider', 'description': 'attending insulin CME Training'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'International Diabetes Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Margaret Powers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Diabetes Center at Park Nicollet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Diabetes Center at Park Nicollet', 'class': 'OTHER'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': 'United Health Care', 'class': 'UNKNOWN'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}