Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-01 @ 7:42 AM
Study NCT ID:
NCT00901992
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-08', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A1c values', 'timeFrame': 'six month follow up after termination of the programs'}], 'secondaryOutcomes': [{'measure': 'Quality of life using the SF 12 mental and physical composite scales', 'timeFrame': 'six month follow up'}, {'measure': 'diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)', 'timeFrame': '6 month follow up'}, {'measure': 'diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)', 'timeFrame': '6 month follow up'}, {'measure': 'Self care behavior (Summary of Self-Care Activities Scale)', 'timeFrame': '6 month follow up'}, {'measure': 'lipids (total cholesterol, triglycerides, HDL and LDL)', 'timeFrame': '6 month follow up'}, {'measure': 'weight (Body mass index)', 'timeFrame': '6 month follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'education', 'self-management', 'insulin therapy'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '21715124', 'type': 'RESULT', 'citation': 'Hermanns N, Kulzer B, Maier B, Mahr M, Haak T. The effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes. Patient Educ Couns. 2012 Feb;86(2):226-32. doi: 10.1016/j.pec.2011.05.017. Epub 2011 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'A new diabetes education program for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) was developed.\n\nIn the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this programs will be tested.\n\nThe results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will be separately analyzed and published.', 'detailedDescription': 'The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help patients perform multiple-injection insulin therapy and adjust their insulin doses depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition, MEDIAS 2 ICT focuses on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.\n\nThe active comparator condition (ACC) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin and a hypertension education program for the treatment of hypertension. These education programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes and hypertension.\n\nBoth treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 lessons, which were conducted as group sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* age \\< 75 and age \\> 17 years\n* two years diabetes duration with oral treatment\n* BMI \\> 20 nad BMI \\< 40 kg/m²\n* informed consent\n\nExclusion Criteria:\n\n* current psychiatric disease\n* dementia or other severe cognitive impairment\n* severe complications\n* severe conditions (e.g., cancer)\n* gestational diabetes'}, 'identificationModule': {'nctId': 'NCT00901992', 'acronym': 'MEDIAS-2-ICT', 'briefTitle': 'Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}, 'officialTitle': 'Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Intensive Insulin Therapy in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'FIDAM-02-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDIAS 2 ICT', 'description': 'MEDIAS 2 ICT - education program for the initiation of intensive conventional insulin treatment (ICT) in type 2 diabetic patients', 'interventionNames': ['Behavioral: MEDIAS 2 ICT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Current ICT program (ACC)', 'description': 'This education program consists of 10 lessons combining an insulin education program with an hypertension program', 'interventionNames': ['Behavioral: Current ICT program (ACC-ICT)']}], 'interventions': [{'name': 'MEDIAS 2 ICT', 'type': 'BEHAVIORAL', 'description': 'MEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants)', 'armGroupLabels': ['MEDIAS 2 ICT']}, {'name': 'Current ICT program (ACC-ICT)', 'type': 'BEHAVIORAL', 'description': 'This program is conducted in 10 lessons in a group setting (4-8 participants)', 'armGroupLabels': ['Current ICT program (ACC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Diabetes Centre Mergentheim', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}], 'overallOfficials': [{'name': 'Norbert Hermanns, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forschungsinstitut der Diabetes Akademie Mergentheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Norbert Hermanns', 'investigatorAffiliation': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}}}}