Type 2 DiabetesNCT06385899
Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background
An observational study of Type 2 Diabetes and Poor Glycemic Control, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Poor Glycemic Control
- How many people
- 266 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed
Who may be able to join
- diagnosed with type 2 diabetes
- give consent to the study
- accessibility to the previous and recent test results
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: The Effect of Close and Intensive Therapeutic Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background
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.
- Conditions
- Type 2 Diabetes, Poor Glycemic Control
- Keywords
- type 2 diabetes, poorly metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c levels after 12 months treatment
Changes in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups.
Measured: twelve months
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%
Measured: twelve months
Secondary outcomes (4)
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.
Measured: twelve months
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
Measured: twelve months
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
Measured: twelve months
The effect of weight loss on the HbA1c changes
The effect of weight loss on reaching HbA1c target of 7% will be compared
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Aug 2021
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Ayse N Erbakan, Principal investigator, Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385899
- Sponsor's protocol ID
- : Poorly controlled T2DM-12
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Close and Intensive Therapeutic Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background
- ClinicalTrials.gov ID
- NCT06385899
- Acronym / sponsor ID
- : Poorly controlled T2DM-12
- Conditions
- Type 2 Diabetes, Poor Glycemic Control
- Keywords
- type 2 diabetes, poorly metabolic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed
Key inclusion criteria (3 listed)
- diagnosed with type 2 diabetes
- give consent to the study
- accessibility to the previous and recent test results
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in HbA1c levels after 12 months treatment
Time frame: twelve months
Changes 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%
Time frame: twelve months
Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%
4 secondary outcomes
The effect of education on the HbA1c changes
Time frame: twelve months
The effect of depression on the HbA1c changes
Time frame: twelve months
The effect of the level of physical activity on the HbA1c changes
Time frame: twelve months
The effect of weight loss on the HbA1c changes
Time frame: twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse N Erbakan principal investigator
Goztepe Prof Dr Suleyman Yalcın City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Poor Glycemic Control, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c levels after 12 months treatment (time frame: twelve months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.