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

Goztepe Training and Research Hospital

Status: Completed

Conditions: Poorly Controlled Diabetes Mellitus; Type 2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT05394571

Poorly controlled T2DM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 4 patient groups

Newly diagnosed diabetes

Description:

Patients who have been diagnosed with type 2 diabetes within a month

Had controlled diabetes before

Description:

Patients who had at least two HbA1c levels =\<%7,5 before enrollment

Had moderately uncontrolled diabetes

Description:

Patients who had at least two HbA1c levels between %7,5 and %9,49 before enrollment

Had poorly controlled diabetes

Description:

Patients who had at least two HbA1c levels above %9,5 before enrollment