NCT07499076

Brief Summary

This randomized controlled study aims to evaluate the effect of mobile application-supported education based on the Health Promotion Model on diabetes management in adolescents aged 12-18 years with Type 1 Diabetes Mellitus. The study will be conducted in a pediatric endocrinology clinic. Participants will be randomly assigned to intervention and control groups. The intervention group will receive mobile application-based diabetes education, while the control group will receive standard care. Outcomes of the study include diabetes knowledge level, self-efficacy, blood glucose monitoring skills, and HbA1c levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 20, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Type 1 DiabetesAdolescent

Outcome Measures

Primary Outcomes (2)

  • Diabetes Management Self-Efficacy Score

    Self-efficacy levels of adolescents will be assessed using a validated scale.

    Baseline and 3 months after intervention

  • Diabetes Management Self-Efficacy Score

    Self-efficacy levels of adolescents with type 1 diabetes will be measured using a validated diabetes self-efficacy scale.

    Baseline and 3 months after intervent

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive mobile application-supported education based on the Health Promotion Model

Behavioral: Mobile Application-Supported Education

Control Group

NO INTERVENTION

Participants will receive standard care without additional mobile application-supported education.

Interventions

A mobile application-based education program developed according to the Health Promotion Model to improve diabetes management in adolescents.

Intervention Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged between 12 and 18 years
  • Diagnosed with Type 1 Diabetes Mellitus
  • Able to use a smartphone
  • Willing to participate in the study
  • Provided informed consent (from parents/guardians if under 18)

You may not qualify if:

  • Presence of any severe chronic disease other than Type 1 Diabetes
  • Cognitive or psychiatric conditions that may affect participation
  • Participation in another intervention study
  • Inability to use a mobile application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes Üniversitesi

Aydin, 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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two groups: intervention and control. The intervention group will receive mobile application-supported education, while the control group will receive standard care.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 30, 2026

Study Start

December 10, 2024

Primary Completion

December 10, 2024

Study Completion

November 10, 2025

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and ethical considerations.

Locations