Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-03-04 @ 10:39 AM
Study NCT ID:
NCT02382757
Status:
TERMINATED
Last Update Posted:
2015-03-09
First Post:
2015-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changing Diabetes in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3089}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2015-03-03', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient assessments: Number of days on insulin', 'timeFrame': 'After 40 months'}, {'measure': 'Number of days with home blood glucose monitoring', 'timeFrame': 'After 40 months'}, {'measure': 'HbA1c (glycosylated haemoglobin)', 'timeFrame': 'After 40 months'}, {'measure': 'Number of episodes of ketoacidosis', 'timeFrame': 'After 40 months'}, {'measure': 'Number of episodes of severe hypoglycaemia', 'timeFrame': 'After 40 months'}, {'measure': 'Long-term complications', 'timeFrame': 'After 40 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of children with HbA1c equal to or below 8.0', 'timeFrame': 'After 40 months'}, {'measure': 'Percentage of children who died during the study', 'timeFrame': 'After 40 months'}, {'measure': 'Percentage of children lost to follow-up', 'timeFrame': 'After 40 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with type 1 diabetes aged below 18 years will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed with type 1 diabetes\n* Parents/caretakers agree to participate in the study\n* Child belongs to the below poverty line economic strata (Centre Director certifies economic status for inclusion in to the study)\n\nExclusion Criteria:\n\n* Children with type 2 diabetes\n* Children from higher economic status\n* Those getting coverage under other government / private schemes'}, 'identificationModule': {'nctId': 'NCT02382757', 'acronym': 'CDiC', 'briefTitle': 'Changing Diabetes in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India', 'orgStudyIdInfo': {'id': 'INS-3982'}, 'secondaryIdInfos': [{'id': 'U1111-1149-2666', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children', 'interventionNames': ['Drug: insulin human']}], 'interventions': [{'name': 'insulin human', 'type': 'DRUG', 'description': 'Children will receive conventional treatment with human insulin according to standard medical practice.', 'armGroupLabels': ['Children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560001', 'city': 'Bangalore', 'country': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}