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))

July 7, 2026 updated by: Shifa Tameer-e-Millat University

Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes A Pilot RCT

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes mellitus (T1DM) is a chronic illness that affects children and adolescents worldwide. It affects approximately 1.52 million individuals under the age of 20 years worldwide. The incidence increased from 7.78 per 100,000 population to 11.07 per 100,000 population from 1990 to 2019. In Pakistan, 7,927 individuals aged 20 years or younger have been diagnosed with T1DM however, this number is most likely underreported.

T1DM is a challenging illness to manage because it requires adherence to strict self-management regimes involving frequent glucose monitoring, insulin administration, balancing physical activity, diet control, and the prevention and management of acute complications. Its management becomes more challenging in adolescents (10-19 years), which is a transitional period from childhood to adulthood. During this phase, significant hormonal and physiological changes occur, which can increase insulin resistance and thus deteriorate glucose metabolism. Furthermore, individuals in their adolescence strive for independence but also tend to socialize more with their agemates, which transforms their eating habits and physical activity patterns. This makes it difficult for adolescents to embrace the responsibility of managing their diabetes. The literature suggests that adolescents with diabetes lack sufficient knowledge and skills to effectively manage their illness. These challenges can result in inadequate glycemic control, as evidenced by higher glycated hemoglobin (HbA1c) levels in adolescents than in children and adults with T1DM. The World Health Organization emphasizes the role of self-efficacy and self-care behaviors in adolescents to improve glycemic control and prevent diabetes-related complications. A recent study in Capital Territory of Pakistan reported that 49.2% of the adolescents with T1DM have inadequate self-care. This study also reported a negative correlation between self-care and HbA1c levels. These findings suggest that self-care practices are the key to achieving better glycemic control.

The literature indicates that structured educational interventions (SEI) can significantly improve healthy lifestyle practices among adolescents with T1DM and enhance their self-efficacy. Diabetes-related education has been shown to reduce the frequency of hypoglycemic episodes and improve glycemic control. Structural intervention programs are the recommended approach for the optimal maintenance of self-care behaviors.

Compared with the conventional approach to education, the use of smartphones by adolescents offers an excellent medium for improving health literacy regarding various health problems, including diabetes. Various mobile health applications (apps) have been developed and are being used to improve health literacy and promote self-management practices in patients with diabetes in various age groups, including adolescents. Some experimental studies have also demonstrated the effectiveness of SEI delivered via mobile health apps in improving self-efficacy and modestly reducing HbA1c in adolescents with T1DM.

Problem Statement Limited interventional research has been conducted on adolescents with T1DM in Pakistan, with the exception of one study. Existing research has primarily focused on the assessment of knowledge, complications, and self-care behaviors. Using a longitudinal design, which evaluated the effectiveness of diabetes care for T1DM patients across various age groups (0 to > 19 years). Patients and their parents provided information on various aspects of T1DM through community-based camps. However, the details of the intervention regarding the duration and mode of delivery have not been reported. Furthermore, this approach may be inappropriate for adolescents. A qualitative study of adolescents with T1DM in Pakistan highlighted several significant challenges regarding the inability of adolescents to independently manage their disease, including complications, psychological stress, and social stigmatization associated with the disease. The participants in this study reported a lack of comprehensive training and formal education in diabetes management. Moreover, Insufficient support from healthcare professionals leads to reliance on informal information sources .

Concomitant with the above findings, I observed my 14-year-old daughter with T1DM relying heavily on Internet sources to seek information regarding her condition. Although a wealth of information is available online, it is crucial to find authentic, age-appropriate, and culture-specific content for adolescents. Globally, several apps are available for the education of adolescents with T1DM. However, existing international apps may not be suitable for the Pakistani context. Details about the international app are provided in Appendix A. The locally available apps are not comprehensive, as they focus on a single aspect of self-care, such as glucose tracking or diet. Moreover, the existing apps only serve as a source of information, but they do not provide an opportunity for the active involvement of adolescents in managing their disease. Given the increasing prevalence, uncontrolled glycemic levels, inadequate self-care in T1DM and unavailability of the age-appropriate apps, it is imperative to design and test a comprehensive structured educational intervention that is feasible and engaging in teaching adolescents about self-care. The literature suggests that adolescents learn more efficiently through mobile apps. Hence, the structured educational intervention will be delivered through a mobile app to improve HbA1c levels, self-efficacy, and self-care practices.

Purpose of the study This study will assess the feasibility of a pilot RCT and evaluate the effectiveness of a structured educational intervention delivered through a mobile app on HbA1c levels, self-efficacy, and self-care among adolescents with T1DM.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care / Control group
Participants 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.
Experimental: Mobile App Educational Intervention
Participants 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.
Behavioral: educational intervention via mobile app
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.
Other Names:
  • MOBILE APP
  • EDUCATIONAL INTERVENTION
  • SUGAR APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBA1C
Time Frame: Baseline and 12 weeks
A reading below 7% indicates satisfactory diabetic control, whereas a reading above 7% indicates poor diabetic control
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Efficacy
Time Frame: Baseline and 12 weeks
it will be measured through Diabetic Management Self-Efficacy Scale ( DMSES) was developed by Van Dar Bijl (1999) and comprises 20 items pertinent to nutrition, diabetes management, glucose monitoring, exercise, weight monitoring, and physician consultation. Each item is rated on a Likert-type scale of 0-10 (0-cannot do it at all - 10 can do it). The scores are calculated by summing all items and dividing by the total number (200) of items. A higher score indicates higher self-efficacy. The Interpretation is: 8-10 indicates high self-efficacy (very confident), 4-7 indicates moderate self-efficacy (somewhat confident), and 0-3 indicates low self-efficacy (lack of confidence).
Baseline and 12 weeks
Self Care
Time Frame: Baseline and 12 weeks
Diabetes Self-Management Questionnaire (DSMQ) The DSMQ was initially developed by the Research Institute of the Diabetes Academy (Mergentheim 2013). . Each item is rated on a 4-point scale from '0' to '3,' where 0 is 'does not apply to me' to 3 and 'applies to me very much.' The scores are calculated by summing all items and then dividing by the total number of items. There are nine negatively keyed items that are reversed before summing with other items. A higher score indicates optimal behavior. Score of,40% indicate poor self-control, while 41-59% moderate SC, 60-79% good and 80-100% indicate Excellent SC.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa Tameer-e-Millat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STMU-T1DM-mHealth-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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