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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%.
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.
Objectives 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
• Secondary objective: To determine the percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7,0%.
Study design The hired medical team (9 specialists) is going to perform the technical study-related tasks in Moscow Region.
Target 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).
A special rented medical bus will accommodate the study personnel at the place and all the local study-related activities.
After 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications | macrovascular complications, i.e. with history of
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7% | 30 days | |
| Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple) | 30 days |
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Inclusion criteria:
The subject population for this study must meet the following criteria:
The prescription of the medicinal product is clearly separated from the decision to include the subject in the study.
Exclusion criteria:
1. Diagnosis of gestational diabetes mellitus alone.
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Patients with type 1 or type 2 Diabetes Mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Marina Shestakova | ERC Moscow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Scientific Center | Moscow | Russia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |