NCT06892821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

March 18, 2025

Last Update Submit

March 22, 2025

Conditions

Type 1 Diabetes Mellitus (T1DM)

Keywords

type 1 diabetes mellituschildrenadolescent

Outcome Measures

Primary Outcomes (2)

  • 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.

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

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

You may not qualify if:

  • other types of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Pediatric Endocrinology, University of Health Sciences

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)