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

The Effect of Close and Intensive Therapeutic Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06385899
Enrollment
266
Registered
2024-04-26
Start date
2021-08-01
Completion date
2023-03-01
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Glycemic Control, Type 2 Diabetes

Keywords

type 2 diabetes, poorly metabolic control

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.

Interventions

None listed

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in HbA1c levels after 12 months treatmenttwelve monthsChanges in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups.
percentage of patients who reached the HbA1c target of equal to or below 7%twelve monthsComparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%

Secondary

MeasureTime frameDescription
The effect of education on the HbA1c changestwelve monthsEducational status may have an impact on HbA1c reduction. Participants who have reached the HbA1c target are compared in terms of their educational level and those who have not.
The effect of depression on the HbA1c changestwelve monthsThe Beck Depression Index will be used to compare participants who reach the HbA1c target and those who do not
The effect of the level of physical activity on the HbA1c changestwelve monthsPhysical activity is graded into 4 levels. Levels will be compared in participants who reach target HbA1c level and who do not
The effect of weight loss on the HbA1c changestwelve monthsThe effect of weight loss on reaching HbA1c target of 7% will be compared

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026