Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-02 @ 8:15 AM
Study NCT ID:
NCT05394532
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-05', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '3 months', 'description': 'The subjects were 83 adolescents diagnosed with type 1 diabetes mellitus. The experiment group intervened with the Steno Balance Card method was better than the control group which received only general health education in terms of blood sugar control after 3 months .'}], 'secondaryOutcomes': [{'measure': 'self management', 'timeFrame': '3 months', 'description': 'There was in scores between the experimental and the control groups three months after intervention which means both health education methods improved the level of self-management in patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 1 diabetes mellitus', 'Steno Balance Card', 'group health education', 'blood sugar control', 'self-management'], 'conditions': ['Type 1 Diabetes', 'HbA1c', 'Self-management']}, 'descriptionModule': {'briefSummary': "The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The main symptoms are the three mores （eat more, drink more and urinate more）, weight loss, urine sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1 is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic Control. If the DKA happened, the patients need to be rescued in the ICU. is because it sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens when the boold sugar is not well controlled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10-18years ord Type 1 DM.\n* Able to read and write Chinese.\n\nExclusion Criteria:\n\n* Communication and cognitive impairments.'}, 'identificationModule': {'nctId': 'NCT05394532', 'briefTitle': 'Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'Effect of Steno Diabetes Dialogue Cards Teaching Instrument on Diabetes in Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'IHLin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steno Diabetes Dialogue Cards', 'interventionNames': ['Other: Education']}], 'interventions': [{'name': 'Education', 'type': 'OTHER', 'description': 'Common Education', 'armGroupLabels': ['Steno Diabetes Dialogue Cards']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112303', 'city': 'Taipei', 'state': 'Beitou', 'country': 'Taiwan', 'facility': 'Fangyi Lin', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master', 'investigatorFullName': 'Lin, I-Hsiang', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}