Evolution of Effectiveness of Diabetes Medical Care in Russia

April 5, 2016 updated by: Endocrinology Research Centre, Moscow
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%.

Study Overview

Status

Completed

Conditions

Detailed Description

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:

  • date of the diagnosis of type 1 or type 2 diabetes mellitus;
  • 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;
  • 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;
  • urine analysis for albumin in spot urine;
  • measurement of height, weight/BMI;
  • measurement of sitting blood pressure, Electocardiogramm;
  • eye examination, including fundoscopy;
  • foot examination, including tests for touch, pain, temperature, and vibration sensation of the toes and mini-doppler ultrasound vessel study;
  • 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.

Study Type

Observational

Enrollment (Actual)

599

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 1 or type 2 Diabetes Mellitus

Description

Inclusion criteria:

The subject population for this study must meet the following criteria:

  1. Provision of singed subject informed consent
  2. 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.

Exclusion criteria:

1. Diagnosis of gestational diabetes mellitus alone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications
Time Frame: 30 days

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 Outcome Measures

Outcome Measure
Time Frame
The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7%
Time Frame: 30 days
30 days
Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple)
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endocrinology Research Centre, Moscow

Investigators

  • Principal Investigator: Marina Shestakova, ERC Moscow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR1410209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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