Evolution of Effectiveness of Diabetes Medical Care in Russia

Endocrinology Research Centre, Moscow

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT02574195

ESR1410209

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 599 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.