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CompletedNCT06385899Updated Apr 26, 2024

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

An observational study in Type 2 Diabetes and Poor Glycemic Control, sponsored by Goztepe Prof Dr Suleyman Yalcın City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Goztepe Prof Dr Suleyman Yalcın City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
266
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes
  • Poor Glycemic Control

Keywords

  • type 2 diabetes
  • poorly metabolic control
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 266 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have been diagnosed

Inclusion criteria

  • diagnosed with type 2 diabetes
  • give consent to the study
  • accessibility to the previous and recent test results

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
266 participants (actual)
Patient registry
No

Groups and cohorts

  • Newly diagnosed diabetes

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

  • Had controlled diabetes before

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

  • Had moderately uncontrolled diabetes

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

  • Had poorly controlled diabetes

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

06

What researchers measure

Primary outcomes

  1. Changes in HbA1c levels after 12 months treatment

    Changes in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups.

    Time frame: twelve months

  2. percentage 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%

    Time frame: twelve months

Secondary outcomes

  1. The effect of education on the HbA1c changes

    Educational 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.

    Time frame: twelve months

  2. The effect of depression on the HbA1c changes

    The Beck Depression Index will be used to compare participants who reach the HbA1c target and those who do not

    Time frame: twelve months

  3. The effect of the level of physical activity on the HbA1c changes

    Physical activity is graded into 4 levels. Levels will be compared in participants who reach target HbA1c level and who do not

    Time frame: twelve months

  4. The effect of weight loss on the HbA1c changes

    The effect of weight loss on reaching HbA1c target of 7% will be compared

    Time frame: twelve months

07

Study locations

1 site
  • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06385899
Lead sponsor
Goztepe Prof Dr Suleyman Yalcın City Hospital
Responsible party
Ayse N Erbakan (The Principal Investigator, Goztepe Prof Dr Suleyman Yalcın City Hospital) — Principal investigator
First posted
Apr 26, 2024
Start date
Aug 1, 2021
Primary completion
Jan 1, 2023
Completion
Mar 1, 2023
Last update
Apr 26, 2024

Study contacts

Ayse N Erbakan
principal investigator · Goztepe Prof Dr Suleyman Yalcın City Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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