Type 1 Diabetes Mellitus (T1DM)NCT06892821
Prospective Cohort Study of Children Diagnosed with Type 1 Diabetes in Türkiye Between 2018 to 2022
An observational study of Type 1 Diabetes Mellitus (T1DM), run by Turkish Pediatric Diabetes Working Group at 1 site in Turkey (Türkiye).
Trial summary
Achieving glycemic targets with improved T1DM management reduces diabetes complications and the risk of progression. Thus, it is essential to identify the challenges in T1DM management within the country and develop strategies for improvement. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM)
- How many people
- 2,730 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2022
- How long will I take part?
- 5 Years
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients diagnosed with type 1 diabetes mellitus between 01.01.2018 and 31.12.2022 at 42 pediatric diabetes centers across 7 regions of Türkiye
Who may be able to join
- Type 1 diabetes mellitus can develop in individuals between the ages of 2 months and 18 years.
Who cannot join
- other types of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
Achieving glycemic targets with improved T1DM management reduces diabetes complications and the risk of progression. Thus, it is essential to identify the challenges in T1DM management within the country and develop strategies for improvement. In Türkiye, there is limited multicenter data regarding the clinical characteristics of children and adolescents with T1DM during the diagnosis and treatment process. This multicenter prospective cohort study aimed to determine the diagnostic and follow-up characteristics of children and adolescents with T1DM, assess the status of diabetes management in the country.
- Conditions
- Type 1 Diabetes Mellitus (T1DM)
- Keywords
- type 1 diabetes mellitus, children, adolescent
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: Through study completion, HbA1c will be measured during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
diabetes microvascular complications
Measured: through study completion, diabetes microvascular complications will be assessed during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies 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
- 2,730 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Turkish Pediatric Diabetes Working Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nursel muratoğlu şahin, Turkish Pediatric Diabetes Working Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892821
- Sponsor's protocol ID
- ZTB14/2018
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Children Diagnosed with Type 1 Diabetes in Türkiye Between 2018 to 2022
- ClinicalTrials.gov ID
- NCT06892821
- Acronym / sponsor ID
- ZTB14/2018
- Conditions
- Type 1 Diabetes Mellitus (T1DM)
- Keywords
- type 1 diabetes mellitus, children, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,730 participants (actual)
- Lead sponsor
- Turkish Pediatric Diabetes Working GroupUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Mar 2025 (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.
Achieving glycemic targets with improved T1DM management reduces diabetes complications and the risk of progression. Thus, it is essential to identify the challenges in T1DM management within the country and develop strategies for improvement. In Türkiye, there is limited multicenter data regarding the clinical characteristics of children and adolescents with T1DM during the diagnosis and treatment process. This multicenter prospective cohort study aimed to determine the diagnostic and follow-up characteristics of children and adolescents with T1DM, assess the status of diabetes management in the country.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients diagnosed with type 1 diabetes mellitus between 01.01.2018 and 31.12.2022 at 42 pediatric diabetes centers across 7 regions of Türkiye
Key inclusion criteria (1 listed)
- Type 1 diabetes mellitus can develop in individuals between the ages of 2 months and 18 years.
Key exclusion criteria (1 listed)
- other types of diabetes mellitus
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
HbA1c
Time frame: Through study completion, HbA1c will be measured during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
diabetes microvascular complications
Time frame: through study completion, diabetes microvascular complications will be assessed during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
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 25 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 Diabetes Mellitus (T1DM), run by Turkish Pediatric Diabetes Working Group 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 1 inclusion and 1 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 25 Mar 2025. 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?
HbA1c (time frame: Through study completion, HbA1c will be measured during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.). 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 25 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.