Evolution of Effectiveness of Diabetes Medical Care in Russia
Evolution of Effectiveness of Diabetes Medical Care in Russia
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:

 -  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.
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.