Prospective Cohort Study of Children Diagnosed with Type... | NCT06892821

Studies
Prospective Cohort Study of Children Diagnosed with Type 1 Diabetes in Türkiye Between 2018 to 2022

NCT06892821

Sponsor

Turkish Pediatric Diabetes Working Group

Status

Completed

Last Update Posted

Mar 25, 2025Actual

Enrollment

2,730Actual

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus (T1DM)

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Mar 18, 2025

First Submission Date that Met QC Criteria

Mar 22, 2025

First Posted Date

Mar 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2025

Last Update Posted Date

Mar 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nursel muratoğlu şahin, Associate Professor, Department of Pediatric Endocrinology, University of Health Sciences, Turkish Pediatric Diabetes Working GroupPrincipal Investigator

Lead Sponsor

Turkish Pediatric Diabetes Working GroupOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,730Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		Through study completion, HbA1c will be measured during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
diabetes microvascular complications		through study completion, diabetes microvascular complications will be assessed during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes mellitus can develop in individuals between the ages of 2 months and 18 years.

Exclusion Criteria:

other types of diabetes mellitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ministry of Health Etlik City Hospital		Ankara	Yenimahalle	06170	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided