Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and HbA1c Changes With Therapy

Study Overview
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Brief Summary
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In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. We aimed to determine the characteristics of patients with type 2 diabetes (HbA1c >=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 3 months.

Detailed Description
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Patients who applied to Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital Diabetes Polyclinics and have an HbA1c levels of >= 10% in their examinations will be admitted to the study. Detailed history, including medication usage and previous blood tests will be questioned. The patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (General practice physical activity questionnaire), and whether they have depression (Beck depression questionnaire). Anthropometric measurements will be taken, and biochemical data will be recorded. Patients will be grouped according to their previous HbA1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. Diabetes follow-up will be continued by their respective physicians. The patients will be called again three months after their enrollment to record the most recent biochemical data. Patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined HbA1c groups. Again, according to the patient groups, the difference in HbA1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

Official Title
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Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and Early Changes in HbA1c Values With Tailored Treatment

Conditions
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Type 2 Diabetes, Poorly Controlled Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with type 2 diabetes give consent to the study accessibility to the previous and recent test results Exclusion Criteria: acute infection or inflammation lasting more than a week acute metabolic decompensation unable to attend to the follow-ups having non-thyroid endocrine diseases active oncologic treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed diabetes<br>Patients who have been diagnosed with type 2 diabetes within a month | |
| Had controlled diabetes before<br>Patients who had at least two HbA1c levels =<%7,5 before enrollment | |
| Had moderately uncontrolled diabetes<br>Patients who had at least two HbA1c levels between %7,5 and %9,49 before enrollment | |
| Had poorly controlled diabetes<br>Patients who had at least two HbA1c levels above %9,5 before enrollment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c levels after 3 months treatment | Changes in HbA1c levels after 3 months treatment according to the predetermined HbA1c groups. | Three months | 
| Changes in HbA1c levels equal to or more than 20% | Comparison of the patient groups according to the reduction of 20% or more in HbA1c levels. | Three months | 
| ratio of patients who reached the HbA1c target of equal to or below 7% | Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of education on the HbA1c changes | The effect of education on HbA1c changes and comparisons between the patient groups. | Three months | 
| The effect of depression on the HbA1c changes | The effect of depression as evaluated with Beck depression test on HbA1c changes and comparisons between the patient groups. | Three months | 
| The effect of the level of physical activity on the HbA1c changes | The effect of physical activity assessed by General practice physical activity questionnaire on HbA1c changes and comparisons between the patient groups. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, poorly controlled Diabetes Mellitus