Clinical trial NCT06385899: Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background
Official title: The Effect of Close and Intensive Therapeutic Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Poor Glycemic Control
Keywords: type 2 diabetes
poorly metabolic control
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed

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.

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

Primary outcomes:
measure: Changes in HbA1c levels after 12 months treatment
timeFrame: twelve months
measure: percentage of patients who reached the HbA1c target of equal to or below 7%
timeFrame: twelve months
Secondary outcomes:
measure: The effect of education on the HbA1c changes
timeFrame: twelve months
measure: The effect of depression on the HbA1c changes
timeFrame: twelve months
measure: The effect of the level of physical activity on the HbA1c changes
timeFrame: twelve months
measure: The effect of weight loss on the HbA1c changes
timeFrame: twelve months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Study officials:
affiliation: Goztepe Prof Dr Suleyman Yalcın City Hospital
name: Ayse N Erbakan
role: PRINCIPAL_INVESTIGATOR
References: