Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00308256
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2006-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2006-03-28', 'studyFirstSubmitQcDate': '2006-03-28', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's acceptance of the disease evaluated by an analogical visual scale rating", 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin', 'timeFrame': '12 months'}, {'measure': 'Number of diabetic acidosis having required hospitalization,', 'timeFrame': '12 months'}, {'measure': 'Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Type1 diabetes;', 'nurse-counselling;', 'adolescent'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26350209', 'type': 'RESULT', 'citation': 'Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lievre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c\\<7%. Adolescents seem to need particularly a better metabolic control.\n\nWorking Hypothesis:\n\nWe hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes.\n\nObjectives:\n\nTo show that nurse-counselling may improve levels of patient satisfaction.\n\nMethodology:\n\nThe main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient\'s appreciation by 10 mm, near to "I cope very well with my diabetes".\n\nThis is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months.\n\nThe total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,\n* HbA1c rate \\> 8 %.\n\nExclusion Criteria:\n\n* HbA1c \\< 8 %;\n* patients participating in another study'}, 'identificationModule': {'nctId': 'NCT00308256', 'briefTitle': 'Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2005.395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse counseling', 'description': 'Phone calls performed by nurse 15 days after each monthly visit', 'interventionNames': ['Behavioral: nurse-counselling']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Normal monthly follow-up without phone calls'}], 'interventions': [{'name': 'nurse-counselling', 'type': 'BEHAVIORAL', 'description': 'Phone calls performed by nurse 15 days after each monthly visit', 'armGroupLabels': ['Nurse counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69005', 'city': 'Lyon', 'country': 'France', 'facility': 'Marc Nicolino', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Marc NICOLINO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}