Clinical trial NCT02574195: Evolution of Effectiveness of Diabetes Medical Care in Russia
Official title: Evolution of Effectiveness of Diabetes Medical Care in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus
microvascular complications
macrovascular complications
epidemiology
Russia
Lead sponsor: Endocrinology Research Centre, Moscow
Sponsor class: OTHER_GOV
First posted: 2015-10-12
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 or type 2 Diabetes Mellitus

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%.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications
timeFrame: 30 days
Secondary outcomes:
measure: The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7%
timeFrame: 30 days
measure: Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple)
timeFrame: 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Endocrinology Scientific Center
Study officials:
affiliation: ERC Moscow
name: Marina Shestakova
role: PRINCIPAL_INVESTIGATOR
References: