Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-07 @ 6:40 PM
Study NCT ID:
NCT02574195
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Effectiveness of Diabetes Medical Care in Russia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 599}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications', 'timeFrame': '30 days', 'description': 'macrovascular complications, i.e. with history of\n\n* chronic heart disease\n* myocardial infarction\n* ischaemic stroke\n* transient ischemic attack\n* any revascularization procedure\n* any peripheral atherosclerosis\n\n e) microvascular complications, i.e.\n* diabetic retinopathy\n* diabetic neuropathy\n* albuminuria\n* chronic kidney disease stage f) other complications diagnosed after diabetes mellitus has been established, i.e.\n* foot examination findings'}], 'secondaryOutcomes': [{'measure': 'The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7%', 'timeFrame': '30 days'}, {'measure': 'Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple)', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'microvascular complications', 'macrovascular complications', 'epidemiology', 'Russia'], 'conditions': ['Diabetes Mellitus, Type 2', 'Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The main aim of the present study is to evaluate the prevalence of individual microvascular and macrovascular complications among diabetes mellitus patients and to determine the percentage of diabetes mellitus patients achieved HbA1c\\<7,0%.', 'detailedDescription': 'Rationale for this Study Primary Existing routine health statistics underestimates the rate of morbidity due to diabetes complications. To provide more realistic estimation of morbidity, repeated epidemiological studies are essential in assessment of tendencies in diabetes medical care at the country level. They allow to reveal issues, which, being resolved, can contribute to the improvement of diabetes medical care effectiveness. Guidelines developed with this study data may save healthcare budgets and prevent financial losses due to diabetes-related morbidity and disability.\n\nObjectives of the Study • Primary objective: To determine the prevalence of individual microvascular and macrovascular complications among patients with diabetes mellitus type 1 and type 2\n\n• Secondary objective: To determine the percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c \\<7,0%.\n\nStudy design The hired medical team (9 specialists) is going to perform the technical study-related tasks in Moscow Region.\n\nTarget population includes approximately 147,000 diabetes mellitus patients included in Regional Diabetes Mellitus Register, from which patients will be selected via random sampling (600 patients).\n\nA special rented medical bus will accommodate the study personnel at the place and all the local study-related activities.\n\nAfter obtaining a written Informed Consent Form by local endocrinologist the each study subject will have one study visit, when he or she should appear fasting and the following data will be collected, tests and examination performed:\n\n* date of the diagnosis of type 1 or type 2 diabetes mellitus;\n* medical history including coronary heart disease, myocardial infarction, coronary revascularization, cerebrovascular disease (ischaemic stroke, a transient ischemic attack), peripheral artery disease, diabetic retinopathy (type, stage, year of diagnosis), diabetic neuropathy, chronic kidney disease, diabetic foot;\n* blood tests for HbA1c, serum total cholesterol, triglycerides, HDL- cholesterol, serum creatinine and estimation estimated Glomerular filtration rate by standard CKD-EPI, alanine-aminotransferase, aspartate-aminotransferase;\n* urine analysis for albumin in spot urine;\n* measurement of height, weight/BMI;\n* measurement of sitting blood pressure, Electocardiogramm;\n* eye examination, including fundoscopy;\n* foot examination, including tests for touch, pain, temperature, and vibration sensation of the toes and mini-doppler ultrasound vessel study;\n* current pharmacological therapy regimen (medications, daily doses). The medical team will admit up to 35 study subjects per day. This study has descriptive character. There is no any comparison to be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 1 or type 2 Diabetes Mellitus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nThe subject population for this study must meet the following criteria:\n\n1. Provision of singed subject informed consent\n2. Type 1 and type 2 diabetes mellitus Target population includes approximately 147,000 diabetes mellitus patients included in Regional DM Register, from which patients will be selected via random sampling (600 patients).\n\nThe prescription of the medicinal product is clearly separated from the decision to include the subject in the study.\n\nExclusion criteria:\n\n1\\. Diagnosis of gestational diabetes mellitus alone.'}, 'identificationModule': {'nctId': 'NCT02574195', 'briefTitle': 'Evolution of Effectiveness of Diabetes Medical Care in Russia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Endocrinology Research Centre, Moscow'}, 'officialTitle': 'Evolution of Effectiveness of Diabetes Medical Care in Russia', 'orgStudyIdInfo': {'id': 'ESR1410209'}}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Endocrinology Scientific Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Marina Shestakova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ERC Moscow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endocrinology Research Centre, Moscow', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}