Evolution of Effectiveness of Diabetes Medical Care in Russia

NCT02574195 | Completed

• 1 other identifier: ESR1410209
• Study Type: observational
• Target: 599
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus; microvascular complications; macrovascular complications; epidemiology; Russia

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications

  macrovascular complications, i.e. with history of * chronic heart disease * myocardial infarction * ischaemic stroke * transient ischemic attack * any revascularization procedure * any peripheral atherosclerosis e) microvascular complications, i.e. * diabetic retinopathy * diabetic neuropathy * albuminuria * chronic kidney disease stage f) other complications diagnosed after diabetes mellitus has been established, i.e. * foot examination findings

  30 days

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 or type 2 Diabetes Mellitus

You may qualify if:

• The subject population for this study must meet the following criteria:
• Provision of singed subject informed consent
• 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).
• The prescription of the medicinal product is clearly separated from the decision to include the subject in the study.

You may not qualify if:

• \. Diagnosis of gestational diabetes mellitus alone.

Sponsors & Collaborators

• Endocrinology Research Centre, Moscow: lead

Study Sites (1)

Endocrinology Scientific Center

Moscow, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marina Shestakova

  ERC Moscow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: October 12, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

RU (1)