Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

NCT ID: NCT06385899

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 266 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-03-01

Brief Summary

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. It is 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 12 months.

Detailed 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 the participants 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.

Conditions

Type 2 Diabetes; Poor Glycemic Control

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Newly diagnosed diabetes

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

No interventions assigned to this group

Had controlled diabetes before

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

No interventions assigned to this group

Had moderately uncontrolled diabetes

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

No interventions assigned to this group

Had poorly controlled diabetes

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayse N Erbakan

The Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse N Erbakan

Role: PRINCIPAL_INVESTIGATOR

Goztepe Prof Dr Suleyman Yalcın City Hospital

Locations

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

: Poorly controlled T2DM-12

Identifier Type: -

Identifier Source: org_study_id