An interventional study of educational intervention via mobile app in Type 1 Diabetes (Juvenile Onset), Type 1 Diabetes and Type 1 Diabetes Mellitus, sponsored by Shifa Tameer-e-Millat University. Not yet recruiting. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Shifa Tameer-e-Millat University · Not applicable, Interventional, and Supportive care
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 84 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Shifa Tameer-e-Millat University is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adolescents aged 10 to 19 years. Diagnosed with Type 1 Diabetes Mellitus (T1DM) by a physician for at least 6 months.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Also known as: MOBILE APP, EDUCATIONAL INTERVENTION, SUGAR APP
HBA1C
A reading below 7% indicates satisfactory diabetic control, whereas a reading above 7% indicates poor diabetic control
Time frame: Baseline and 12 weeks
Self Efficacy
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).
Time frame: Baseline and 12 weeks
Self Care
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.
Time frame: Baseline and 12 weeks
No study locations are listed for this record.
Plan to share: No — 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."
Start is estimated for Jul 2026; primary completion for Oct 2026, 3 months later.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 3 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shifa Tameer-e-Millat University