Diabetes Mellitus, Type 2NCT02574195
Evolution of Effectiveness of Diabetes Medical Care in Russia
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Endocrinology Research Centre, Moscow at 1 site in Russia.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- How many people
- 599 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 1 or type 2 Diabetes Mellitus
Who may be able to join
- 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.
Who cannot join
- 1. Diagnosis of gestational diabetes mellitus alone.
Trial locations and contacts
1 site in 1 country.
About this study
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%.
Read the 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.
- Keywords
- Diabetes Mellitus, microvascular complications, macrovascular complications, epidemiology, Russia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 30 days
Secondary outcomes (2)
The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7%
Measured: 30 days
Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocrinology Research Centre, Moscow
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marina Shestakova, Principal investigator, ERC Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574195
- Sponsor's protocol ID
- ESR1410209
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Effectiveness of Diabetes Medical Care in Russia
- ClinicalTrials.gov ID
- NCT02574195
- Acronym / sponsor ID
- ESR1410209
- Keywords
- Diabetes Mellitus, microvascular complications, macrovascular complications, epidemiology, Russia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Endocrinology Research Centre, MoscowOther government
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 or type 2 Diabetes Mellitus
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Diagnosis of gestational diabetes mellitus alone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
The percentage of patients with diabetes mellitus type 1 and type 2 achieved HbA1c <7%
Time frame: 30 days
Structure of antidiabetic therapy (% insulin, % OAD mono, % OAD dual, % OAD triple)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Shestakova principal investigator
ERC Moscow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Endocrinology Research Centre, Moscow at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with diabetes mellitus type 1 and type 2diabetes mellitus complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.