Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-01 @ 2:04 PM
Study NCT ID:
NCT03835195
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2019-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Care in Type 1 Diabetes and Associated Outcomes
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in HbA1C value after the intervention', 'timeFrame': '4-9 months', 'description': 'It was considered as a measure of the before. The last glycated hemoglobin of the patient before starting care in the health institution, when his measurement time was not more than 6 months.\n\nOtherwise, the value of the first HbA1C measured in the first 15 days of admission to the health institution was considered, since it reflects the level of basal glycemic control, with which the patient was referred to the institution. The post-intervention measurement corresponded to the last HbA1C measured at 4-9 months of follow-up in the institution.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients diagnosed with dyslipidemia after the intervention', 'timeFrame': '4-9 months', 'description': "The measurement of the previous one corresponded to the diagnosis of dyslipidemia reported in the patient's clinical history before starting care in the institution. The postintervention measurement corresponded to the diagnosis of dyslipidemia reported in the clinical history at 4-9 months."}, {'measure': 'Proportion of patients with hypoglycaemia after the intervention', 'timeFrame': '4-9 months', 'description': "The measurement of the before, corresponded to the report of at least one hypoglycaemia in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the report of hypoglycaemia in the clinical history at 4-9 months.\n\nThe measurement of the previous one corresponded to the diagnosis of HBP reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months."}, {'measure': 'Number of hospitalizations associated with diabetes, after the intervention', 'timeFrame': '4-9 months', 'description': 'The measurement of the before, corresponded to the number of hospitalizations associated with diabetes, in the year prior to admission to the institution. The measurement afterwards corresponded to the measurement of hospitalizations during the Clid follow-up and in the subsequent 6 months.'}, {'measure': 'Proportion of patients diagnosed with hypertension after the intervention', 'timeFrame': '4-9 months', 'description': "The measurement of the previous one corresponded to the diagnosis of High Blood Pressure reported in the patient's clinical history before starting the care in the institution. The postintervention measurement corresponded to the diagnosis of hypertension reported in the clinical history at 4-9 months."}, {'measure': 'Difference in the body mass index after the intervention', 'timeFrame': '4-9 months', 'description': 'The measure corresponds to the records in the admission consultation (before) and in the consultation at 4-9 months (after) in the institution.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Quasi-experimental, retrospective, before and after study, with a control group, to evaluate the effect of an intervention based on disease management, on metabolic control and hospitalizations, in a group of patients with type Diabetes 1, attended in a Provider Institution of Health Services of the city of Medellin - Colombia.', 'detailedDescription': 'Evaluate the effect of an intervention based on the management of the disease, on metabolic control and the number of hospitalizations related to diabetes, in a group of patients with Type 1 Diabetes attended in a specialized Health Services Provider Institution in the city of Medellin - Colombia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with type 1 diabetes.\n* Patients affiliated to the Entity Administrator of Health Benefits Plans (EPS Sura)\n* Patients with age greater than or equal to 15 years, who had been referred to the institution at the discretion of the treating physician, for poor metabolic control and had to enter a hemoglobin glycated (HbA1C) ≥ 7.0%.\n\nExclusion Criteria:\n\n* Patients who at the time of recruitment were treated with continuous insulin infusion device (insulin pump) and patients with gestational diabetes were excluded.'}, 'identificationModule': {'nctId': 'NCT03835195', 'acronym': 'AIDDA', 'briefTitle': 'Comprehensive Care in Type 1 Diabetes and Associated Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Comprehensive Care in Type 1 Diabetes and Associated Outcomes: AIDDA: a Quasiexperimental Study.', 'orgStudyIdInfo': {'id': 'AIDDA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Disease Management Program', 'description': 'Diabetes Disease Management Program', 'interventionNames': ['Other: Diabetes Disease Management Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Process', 'description': 'Usual care process', 'interventionNames': ['Other: Usual Care Process']}], 'interventions': [{'name': 'Diabetes Disease Management Program', 'type': 'OTHER', 'description': 'The attention is carried out in a single physical place, in the city of Medellin. The scheme of intervention in the comprehensive Diabetes Clinic is based on the concept of disease management. The intervention is composed of 5 phases, which apply to all the patients cared for in the institution (access, reception, entry, clinical consultation, management plan, education, pharmaceutical care). The healthcare team consists of 5 endocrinologists, an endocrinologist pediatrician, 7 general practitioners trained in diabetes, 5 pharmacists trained in diabetes and certified in education for patients with diabetes and 3 nutritionists.', 'armGroupLabels': ['Diabetes Disease Management Program']}, {'name': 'Usual Care Process', 'type': 'OTHER', 'description': "The patients are treated in the cardiovascular risk clinic (general practitioners) of their Primary Healthcare Provider Institution or by specialists in internal medicine, pediatrics or endocrinology in the different Provider Institutions of Health Services of the insurance service network of health or in private doctors' offices assigned to the insurer. In some cases there is assisted consultation (general practitioner - specialist). There is no defined periodicity for follow-up; Appointments are assigned to need, according to the criteria of the treating physicians. In some cases there is remission to educational activities, not necessarily focused on type 1 diabetes.", 'armGroupLabels': ['Usual Care Process']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Clínica Integral de Diabetes', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'John Jairo Zuleta Tobón, MD, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Antioquia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}