Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes (T1DM)
(T1DM)
1 other identifier
interventional
84
0 countries
N/A
Brief Summary
This study aims to evaluate the effectiveness of a mobile health (mHealth) educational intervention for adolescents with Type 1 Diabetes Mellitus (T1DM). Adolescents often face challenges in maintaining optimal blood glucose control and performing regular self-care. In this study, participants will receive structured diabetes education through a mobile application designed to improve their knowledge, self-efficacy (SE), and self-management skills. The impact of the intervention will be assessed by measuring changes in HbA1c levels, diabetes self-efficacy, and self-care (SC)behaviors over time. These findings may help determine whether mobile app-based education can support better diabetes management among adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
February 10, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedFirst Posted
Study publicly available on registry
July 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
July 8, 2026
July 1, 2026
4 months
February 10, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBA1C
A reading below 7% indicates satisfactory diabetic control, whereas a reading above 7% indicates poor diabetic control
Baseline and 12 weeks
Secondary Outcomes (2)
Self Efficacy
Baseline and 12 weeks
Self Care
Baseline and 12 weeks
Study Arms (2)
Standard Care / Control group
NO INTERVENTIONParticipants in this group will receive routine standard care for Type 1 Diabetes without access to the educational mobile application. Outcomes such as HbA1c, self-efficacy, and self-care behaviors will be measured in the same way as the intervention group to allow comparison.
Mobile App Educational Intervention
EXPERIMENTALParticipants in this group will receive structured diabetes education through a mobile application designed for adolescents with Type 1 Diabetes. The app provides interactive lessons, self-care tips, reminders, and tracking tools to improve diabetes knowledge, self-efficacy, and self-management behaviors. The impact will be assessed through changes in HbA1c, self-efficacy, and self-care practices over the study period.
Interventions
The duration of this intervention will be 12 weeks.The SEI will comprised of knowledge and skills related to self care in T1DM. Topics of knowledge will include descriptions of T1DM, insulin, diet management, physical activity, diabetes-related complications, sick day management, skin care, including foot care, and mental and social health issues. Moreover, the participants will be taught skills for monitoring blood glucose, insulin administration, and weight measurement.
Eligibility Criteria
You may qualify if:
- Adolescents aged 10 to 19 years. Diagnosed with Type 1 Diabetes Mellitus (T1DM) by a physician for at least 6 months.
- HbA1c greater than or equal to 7%. Have access to a smartphone or tablet (owned by the participant or parent/guardian).
You may not qualify if:
- Use of an insulin pump. Current use of any smartphone application for diabetes self-management. Presence of comorbid conditions that may interfere with participation in the study.
- Diagnosis of intellectual disability or other cognitive impairment documented in the medical record that may limit the participant's ability to complete questionnaires or comply with intervention requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Abraham, M. B., Jones, T. W., Naranjo, D., Karges, B., Oduwole, A., Tauschmann, M., & Maahs, D. M. (2018). ISPAD Clinical Practice Consensus Guidelines 2018: Assessment and management of hypoglycemia in children and adolescents with diabetes. Pediatric diabetes, 19. Adolescent Health. (2023, Jan, 20). https://www.who.int/health-topics/adolescent-health#tab=tab_1 Adolfsson, P., Taplin, C. E., Zaharieva, D. P., Pemberton, J., Davis, E. A., Riddell, M. C., ... & DiMeglio, L. A. (2022). ISPAD Clinical Practice Consensus Guidelines 2022: Exercise in children and adolescents with diabetes. Pediatric Diabetes, 23(8), 1341-1372. Ahmedani, M. Y., Fawwad, A., Shaheen, F., Tahir, B., Waris, N., & Basit, A. (2019). Optimized health care for subjects with type 1 diabetes in a resource constraint society: A three-year follow-up study from Pakistan. World journal of diabetes, 10(3), 224. Ahmed, K. S., Roohi, N., Ahmed, M. S., Rana, M. S., & Hussain, N. (2024). Type 1 diabetes mellitus and its complications in children aged ≤ 20 years from Punjab , Pakistan. 13(1), 1-7. https://doi.org/10.15275/rusomj.2024.0106 Ali, S., Rizvi, S. A. A., & Qureshi, M. S. (2014). Cell phone mania and Pakistani youth: Exploring the cell phone usage patterns among teenagers of South Punjab. FWU Journal of Social Sciences, 8(2), 43. Alves, L. D. F. P. A., Maia, M. M., Araújo, M. F. M. D., Damasceno, M. M. C., & Freitas, R. W. J. F. D. (2021). Development and validation of a MHEALTH technology for the promotion of self-care for adolescents with diabetes. Ciencia & saude coletiva, 26, 1691-1700. American Diabetes Association. (2023). 2. Classification and diagnosis of diabetes: Standards of care in diabetes2023. Diabetes Care, 46, S19-S40. American Diabetes Association. (2019). 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care, 42 (Supplement_1): S90-S102 https://doi.org/10.2337/dc19-S009 American Diabetes Association. (2020). 2. Classification
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
July 8, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
July 8, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared. All data collected in this study will be used solely for research purposes and will be kept confidential in accordance with ethical approvals and institutional guidelines."