Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06883318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-18', 'size': 355311, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-18T12:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115000}, 'targetDuration': '50 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of type 1', 'timeFrame': 'From the inception of the data base in July 1977 through 2029', 'description': 'Incidence of type 1 diabetes in individuals below 15 years of age in Sweden'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Childhood-onset', 'Risk factors', 'Complications', 'Socioeconomic conditions'], 'conditions': ['Type 1 Diabetes Mellitus (T1DM)', 'End-Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The researchers study time trends of childhood-onset type 1 diabetes and its most serious complication, end-stage renal disease. They further analyse physical, psychological and socio-economic long-term effects on patients and families to identify potentially preventive factors in a population perspective. The researchers investigate the economic burden of disease and study and improve statistical methods for case-control data. The projects use a longitudinal nationwide database involving about 23 000 childhood-onset diabetes cases with maximum follow-up of 48 years and for each case 4 matched controls. The Swedish Childhood Diabetes Register is linked to a number of official, Swedish registers: the Renal register, the Cause of Death register, the National Patient register, the Prescribed Drugs register, the Cancer register and the Integrated Database for Labour Market Research. The researchers use GAM modelling for time trend analyses, standard case-control/cohort analyses, Cox regression for life table analyses, linear fixed effect probability for career development and propensity score models for confounding. The project group is multidisciplinary and involves experts in paediatrics, nephrology, epidemiology, health economics and statistics. This unique database and team continues to yield population-based new knowledge on the consequences of this increasingly common chronic childhood-onset disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Swedish Childhood Diabetes Register (SCDR) is based on collaboration with all paediatric clinics in Sweden; from 1977 until 2010 the clinics helped with data collection. Since 2011 the National Board of Health provides new incident data from insulin pre-scriptions using the Prescribed Drug register (PDR). It recruits all cases of type 1 diabetes in children below 15 years. To each case four controls have been assigned through Statistics Sweden.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two prescriptions of insulin in the Prescribed Drug register.\n* Age below 15 years of age. Controls are of the same age and born in the same municipality as the cases.\n\nExclusion Criteria:\n\n* No'}, 'identificationModule': {'nctId': 'NCT06883318', 'briefTitle': 'Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden - Longitudinal Register Based Studies', 'orgStudyIdInfo': {'id': '2019-02492'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases with childhood-onset type 1 diabetes'}, {'label': 'Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '901 87', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Department of Clinical Sciences, Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data come from official Swedish registers through Statistics Sweden and National Board of Health and Welfare where researchers have access to pseudonymonised information. The ethical permit does not allow sharing of data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}, {'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}