Type 1 Diabetes MellitusDiaBuddyNCT07861373
DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes
A study testing DiaBuddy: AI-Enabled Digital Self-Management Intervention and Usual Diabetes Care in people with Type 1 Diabetes Mellitus and Diabetes Self-Management Education, run by Dr. Juwayria Omar.
Trial summary
The goal of this clinical trial is to learn whether DiaBuddy, a digital self-management app, can help children and adolescents with Type 1 diabetes better manage their condition and reduce the burden experienced by their caregivers. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Diabetes Self-Management Education, Caregiver Burden
- What is being tested?
- DiaBuddy: AI-Enabled Digital Self-Management Intervention and Usual Diabetes Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to 2 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged 6-17 years at the time of enrollment.
- Confirmed diagnosis of Type 1 diabetes mellitus for at least 6 months.
- Resident of Pakistan.
- Parent or primary caregiver actively involved in the participant's diabetes care and willing to participate in the study.
- Access to a compatible smartphone or digital device capable of running the DiaBuddy application.
- Parent or legally authorized representative willing to provide informed consent.
- Child/adolescent willing to provide age-appropriate assent, where applicable.
- Participant and caregiver willing and able to comply with study procedures and follow-up assessments.
Who cannot join
- Cognitive, developmental, or other impairment that substantially limits the participant's ability to understand or use the intervention or complete study assessments.
- Severe or unstable medical illness that, in the judgment of the study investigator, would substantially interfere with study participation or follow-up.
- End-stage renal disease.
- Proliferative diabetic retinopathy.
- Recurrent severe diabetic ketoacidosis requiring intensive care that would substantially interfere with study participation or follow-up.
- Any other medical, psychosocial, or logistical condition that, in the judgment of the investigator, would make participation inappropriate or prevent completion of the study procedures.
About this study
Official title: Effect of an AI-Empowered Digital Self-Management Intervention on Glycemic Control and Caregiver Burden in Children and Adolescents With Type 1 Diabetes Mellitus: A Multicenter Randomized Controlled Trial in Pakistan
The goal of this clinical trial is to learn whether DiaBuddy, a digital self-management app, can help children and adolescents with Type 1 diabetes better manage their condition and reduce the burden experienced by their caregivers. The study will include children and adolescents aged 6 to 17 years with Type 1 diabetes who live in Pakistan.
The main questions it aims to answer are:
Read more
- Does using DiaBuddy along with usual diabetes care improve diabetes self-management and adherence?
- Does using DiaBuddy along with usual diabetes care reduce caregiver burden?
- Does using DiaBuddy affect blood sugar control, diabetes-related distress, and other diabetes-related health outcomes?
- Is DiaBuddy acceptable and useful for children, adolescents, and their caregivers?
Researchers will compare participants who use DiaBuddy along with their usual diabetes care with participants who receive usual diabetes care alone.
Participants will:
- Use DiaBuddy to record and review information related to their diabetes, including blood glucose and self-management activities.
- Receive diabetes education, reminders, and self-management support through the app.
- Complete questionnaires about diabetes self-management, diabetes-related experiences, and caregiver burden.
- Have blood sugar control assessed through laboratory-verified HbA1c measurements.
- Attend scheduled follow-up assessments at approximately 3 and 6 months.
- Report relevant diabetes-related health events, such as hypoglycemia, diabetic ketoacidosis, emergency visits, and hospitalization.
Read the detailed description
Type 1 diabetes mellitus (T1DM) requires continuous daily management, including glucose monitoring, insulin administration, dietary decisions, physical activity, recognition of abnormal glucose levels, and management of diabetes-related risks. For children and adolescents, this management is shared between the child and caregiver, and responsibility gradually shifts toward the child with increasing age and independence. This can create challenges related to adherence, diabetes-related distress, and caregiver burden.
DiaBuddy is an artificial intelligence (AI)-empowered digital self-management intervention developed to support children and adolescents with T1DM and their caregivers. The intervention is intended to complement, rather than replace, routine diabetes care. It provides digital tools for recording and reviewing diabetes-management information, educational content, reminders, motivational features, and caregiver support.
The application includes functions such as glucose logging and trend visualization, insulin and meal/snack reminders, physical activity reminders, hypoglycemia alerts, diabetes safety and diabetic ketoacidosis (DKA) education, educational videos, interactive quizzes, Urdu and English content, points, badges and rewards, caregiver dashboards, child-caregiver account linking, weekly summaries, synchronization, offline functionality where supported, and technical support.
DiaBuddy will also incorporate AI-supported analysis of available longitudinal diabetes-management information, such as glucose readings, insulin information, dietary information, physical activity information, and previous glucose patterns. The AI may provide individualized information concerning glucose trends, dietary considerations, physical activity, anticipated glucose patterns, diabetes-management reminders, and when medical review may be appropriate.
The AI component is designed as a decision-support and self-management tool. It will not independently change or administer insulin doses. Any insulin-related suggestion will remain subject to the participant's or caregiver's existing clinical management plan and treating clinician oversight. DiaBuddy will not replace treating physicians, routine diabetes care, emergency medical services, or clinical decision-making.
The definitive trial follows a preliminary DiaBuddy pilot. The pilot provided information about feasibility, usability, technical issues, questionnaire administration, recruitment, follow-up, and preliminary changes in self-management, caregiver burden, diabetes-related distress, and reported caregiving time. Because the pilot did not include a control group and was short in duration, it cannot determine whether observed changes were specifically attributable to DiaBuddy. The randomized controlled trial is therefore designed to provide a controlled comparison of DiaBuddy added to usual diabetes care versus usual diabetes care alone.
Participants will be followed for six months, with assessments planned at baseline, approximately three months, and approximately six months. Clinical and participant-reported information will be collected throughout follow-up. Laboratory-verified glycated hemoglobin (HbA1c) will be used to assess glycemic control. The study will also monitor relevant diabetes-related events and healthcare utilization, including hypoglycemia, severe hypoglycemia, DKA, emergency department visits, and diabetes-related hospitalization.
Safety monitoring will include potentially harmful AI outputs and technical failures that could affect participant safety in addition to clinical safety events. Participants will be informed that DiaBuddy is not an emergency service and that clinical emergencies should be managed through their treating healthcare team or appropriate emergency services.
Before the trial begins, the randomized controlled trial (RCT) version of the application will be documented, including the permitted and prohibited AI outputs, insulin-related safeguards, human oversight procedures, software and AI version control, handling of erroneous or incomplete information, and procedures for reporting potentially serious AI-related incidents. Changes to the software or AI system during the trial will be documented.
The trial is intended to determine whether adding DiaBuddy to usual diabetes care provides meaningful improvements in diabetes self-management and caregiver outcomes while also evaluating clinical outcomes, safety, usability, and engagement. The longer-term objective is to develop a safe and evidence-based digital self-management platform that may subsequently be evaluated for implementation within routine diabetes care in Pakistan.
- Being tested
- DiaBuddy: AI-Enabled Digital Self-Management Intervention, Usual Diabetes Care
- Keywords
- Pediatric Diabetes, Digital health, Mobile health, DiaBuddy, Diabetes self-management education, Digital diabetes intervention, Glycemic control, HbA1c, Caregiver burden, Artificial intelligence, AI-assisted self-management, Pakistan, Type 1 diabetes, Patient education
- Medical subject headings
- Diabetes Mellitus, Type 1, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaBuddy: AI-Enabled Digital Self-Management InterventionBehavioural
DiaBuddy is an AI-enabled digital self-management intervention designed to support children aged 6-17 years with T1DM and their caregivers. The intervention provides tools for glucose logging and trend visualization, insulin and medication reminders, snack and exercise reminders, hypoglycemia and DKA educational alerts, diabetes education through videos, quizzes, cartoons and animations, and English and Urdu language options. It also includes points, badges and rewards to encourage engagement, caregiver-child linking, and a caregiver dashboard with weekly summaries. AI-supported features may assist with interpretation of glucose trends and provide general self-management recommendations; however, the system does not autonomously modify insulin doses, and insulin-related decisions remain under clinical supervision. Participants will use DiaBuddy alongside their usual diabetes care during the intervention period.
Usual Diabetes CareOther
Participants assigned to the usual care arm will continue to receive standard diabetes care according to the routine practices of their treating healthcare team. Usual care may include routine clinical follow-up, insulin therapy, blood glucose monitoring, dietary and physical-activity counseling, diabetes education, and management of acute and chronic diabetes-related concerns as clinically indicated. Participants in this arm will not receive access to the DiaBuddy digital self-management intervention during the study period.
| Study group | Role | What they receive |
|---|---|---|
| DiaBuddy + Usual Diabetes Care | Experimental | Participants assigned to this arm will receive access to DiaBuddy in addition to their usual diabetes care for 6 months. DiaBuddy is an AI-empowered digital self-management and decision-support intervention that provides tools for glucose logging and trend visualization, insulin, meal/snack, and physical activity reminders, hypoglycemia alerts, diabetes safety and DKA education, educational videos and quizzes, Urdu and English content, motivational features, caregiver support, and weekly summaries. The AI component may provide individualized self-management information and recommendations based on available diabetes-management information. DiaBuddy will not independently change or administer insulin doses and will not replace routine clinical care or emergency medical services. Receives: Behavioral: DiaBuddy: AI-Enabled Digital Self-Management Intervention |
| Usual Care | Active comparator | Participants in this arm will receive usual standard diabetes care as provided by their treating healthcare team. They will not receive access to the DiaBuddy digital intervention during the study period. Usual care may include routine clinical follow-up, insulin therapy, blood glucose monitoring, dietary and physical-activity guidance, diabetes education, and other standard services according to the participant's treating team. Receives: Other: Usual Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Diabetes Self-Management/Adherence Score
Change in child diabetes self-management/adherence score assessed using the modified Self-Care Inventory-Revised (SCI-R). Higher scores indicate better self-management/adherence.
Measured: Baseline and 6 months after randomization
Secondary outcomes (3)
Change in Child Diabetes-Related Distress Score
Change in diabetes-related distress assessed using the study's specified child distress measure/emoji-based assessment. Lower scores indicate lower diabetes-related distress.
Measured: Baseline and 6 months after randomization
Change in Glycated Hemoglobin (HbA1c) Level
Change in glycated hemoglobin (HbA1c), measured as a clinical indicator of glycemic control.
Measured: Baseline and 6 months after randomization
Change in Diabetes-Related Caregiving Time
Change in caregiver-reported time spent on diabetes-related caregiving activities, reported in hours per day. Lower values indicate reduced caregiving time.
Measured: Baseline and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either DiaBuddy plus usual diabetes care or usual diabetes care alone. Participants will remain in their assigned group throughout the 6-month study period and will undergo assessments at baseline, approximately 3 months, and approximately 6 months. The study will compare changes in diabetes self-management/adherence, caregiver burden, and other prespecified clinical, behavioral, and safety outcomes between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Juwayria Omar
- Sponsor type
- University, hospital or other
- Collaborators
- Air University, Islamabad, Pakistan Institute of Medical Sciences
- Responsible party
- Sponsor-investigator, Dr. Juwayria Omar, Air University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861373
- Sponsor's protocol ID
- DIABUDDY-RCT-2026
- Acronym
- DiaBuddy
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in the publication, after de-identification, may be shared with qualified researchers upon reasonable request. Data that could directly or indirectly identify participants will not be shared. Requests will be reviewed by the study investigators and will be subject to applicable ethical, privacy, and data-protection requirements. The shared dataset may include de-identified participant characteristics, intervention assignment, outcome measures, and relevant baseline and follow-up data. Data will be made available after publication of the primary study results, subject to appropriate data-use requirements.
Publications
de Wit M, Gajewska KA, Goethals ER, McDarby V, Zhao X, Hapunda G, Delamater AM, DiMeglio LA. ISPAD Clinical Practice Consensus Guidelines 2022: Psychological care of children, adolescents and young adults with diabetes. Pediatr Diabetes. 2022 Dec;23(8):1373-1389. doi: 10.1111/pedi.13428. Epub 2022 Dec 5. No abstract available.
PubMed 36464988Tauschmann M, Forlenza G, Hood K, Cardona-Hernandez R, Giani E, Hendrieckx C, DeSalvo DJ, Laffel LM, Saboo B, Wheeler BJ, Laptev DN, Yarhere I, DiMeglio LA. ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Glucose monitoring. Pediatr Diabetes. 2022 Dec;23(8):1390-1405. doi: 10.1111/pedi.13451. No abstract available.
PubMed 36537528Lindholm Olinder A, DeAbreu M, Greene S, Haugstvedt A, Lange K, Majaliwa ES, Pais V, Pelicand J, Town M, Mahmud FH. ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes education in children and adolescents. Pediatr Diabetes. 2022 Dec;23(8):1229-1242. doi: 10.1111/pedi.13418. No abstract available.
PubMed 36120721Cejalvo E, Gisbert-Perez J, Marti-Vilar M, Badenes-Ribera L. Systematic review following COSMIN guidelines: Short forms of Zarit Burden Interview. Geriatr Nurs. 2024 Sep-Oct;59:278-295. doi: 10.1016/j.gerinurse.2024.07.002. Epub 2024 Aug 1.
PubMed 39094351Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
PubMed 15920050Feldman M, Kwong GPS, Ho J. Caregiver knowledge of hypoglycemia and hyperglycemia management in children and adolescents with type 1 diabetes. Diabetes Epidemiol Manag. 2025;19-20:100267. doi:10.1016/j.deman.2025.100267.
Bilgehan T, Bagriacik E, Sonmez M. Factors affecting care burden and life satisfaction among parents of children with type 1 diabetes. J Pediatr Nurs. 2024 Jul-Aug;77:e394-e400. doi: 10.1016/j.pedn.2024.05.002. Epub 2024 May 10.
PubMed 38729898Rubab H, Aziz F, Gul R, Froelicher ES. Effect of a structured educational intervention delivered through a mobile application on glycated haemoglobin and self-efficacy in adolescents with type 1 diabetes mellitus: a systematic review and meta-analysis. BMJ Open. 2025 Sep 10;15(9):e093798. doi: 10.1136/bmjopen-2024-093798.
PubMed 40935425Zhang K, Huang Q, Wang Q, Li C, Zheng Q, Li Z, Xu D, Xie C, Zhang M, Lin R. Telemedicine in Improving Glycemic Control Among Children and Adolescents With Type 1 Diabetes Mellitus: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Jul 9;26:e51538. doi: 10.2196/51538.
PubMed 38981114Rostaminasab S, Nematollahi M, Jahani Y, Mehdipour-Rabori R. The effect of family-centered empowerment model on burden of care in parents and blood glucose level of children with type I diabetes family empowerment on burden of care and HbA1C. BMC Nurs. 2023 Jun 20;22(1):214. doi: 10.1186/s12912-023-01375-w.
PubMed 37340394Goyal S, Nunn CA, Rotondi M, Couperthwaite AB, Reiser S, Simone A, Katzman DK, Cafazzo JA, Palmert MR. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336.
PubMed 28630037Carrigan A, Meulenbroeks I, Sarkies M, Dammery G, Halim N, Singh N, Lake R, Davis E, Jones TW, Braithwaite J, Zurynski Y. Benefits, implementation and sustainability of innovative paediatric models of care for children with type 1 diabetes: a systematic review. BMC Pediatr. 2024 Aug 5;24(1):502. doi: 10.1186/s12887-024-04945-2.
PubMed 39103837Jawad M, Afaq S, Hussain S, Jamal SF, Haq ZU, Hussain A, Rehman A, Khan S, Almuradi MAA. Effect of digital interventions on adherence to the management of type 1 diabetes mellitus patients: a systematic review. BMC Endocr Disord. 2025 Dec 30;25(1):293. doi: 10.1186/s12902-025-02100-1.
PubMed 41462455Azimi T, Johnson J, Campbell SM, Montesanti S. Caregiver burden among parents of children with type 1 diabetes: A qualitative scoping review. Heliyon. 2024 Mar 12;10(6):e27539. doi: 10.1016/j.heliyon.2024.e27539. eCollection 2024 Mar 30.
PubMed 38524615Jabeen Z, Baig AM, Khawaja KI, Shabbir S, Afzal Z. Diabetes Distress Among Type 1 Diabetic Adolescents in a Tertiary Care Hospital in Pakistan. Cureus. 2022 Dec 11;14(12):e32392. doi: 10.7759/cureus.32392. eCollection 2022 Dec.
PubMed 36636548
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an AI-Empowered Digital Self-Management Intervention on Glycemic Control and Caregiver Burden in Children and Adolescents With Type 1 Diabetes Mellitus: A Multicenter Randomized Controlled Trial in Pakistan
- ClinicalTrials.gov ID
- NCT07861373
- Acronym / sponsor ID
- DiaBuddy / DIABUDDY-RCT-2026
- Keywords
- Pediatric Diabetes, Digital health, Mobile health, DiaBuddy, Diabetes self-management education, Digital diabetes intervention, Glycemic control, HbA1c
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Dr. Juwayria OmarUniversity, hospital or other
- Collaborators
- Air University, Islamabad, Pakistan Institute of Medical Sciences
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether DiaBuddy, a digital self-management app, can help children and adolescents with Type 1 diabetes better manage their condition and reduce the burden experienced by their caregivers. The study will include children and adolescents aged 6 to 17 years with Type 1 diabetes who live in Pakistan.
The main questions it aims to answer are:
- Does using DiaBuddy along with usual diabetes care improve diabetes self-management and adherence?
- Does using DiaBuddy along with usual diabetes care reduce caregiver burden?
- Does using DiaBuddy affect blood sugar control, diabetes-related distress, and other diabetes-related health outcomes?
- Is DiaBuddy acceptable and useful for children, adolescents, and their caregivers?
Researchers will compare participants who use DiaBuddy along with their usual diabetes care with participants who receive usual diabetes care alone.
Participants will:
- Use DiaBuddy to record and review information related to their diabetes, including blood glucose and self-management activities.
- Receive diabetes education, reminders, and self-management support through the app.
- Complete questionnaires about diabetes self-management, diabetes-related experiences, and caregiver burden.
- Have blood sugar control assessed through laboratory-verified HbA1c measurements.
- Attend scheduled follow-up assessments at approximately 3 and 6 months.
- Report relevant diabetes-related health events, such as hypoglycemia, diabetic ketoacidosis, emergency visits, and hospitalization.
Detailed description
Type 1 diabetes mellitus (T1DM) requires continuous daily management, including glucose monitoring, insulin administration, dietary decisions, physical activity, recognition of abnormal glucose levels, and management of diabetes-related risks. For children and adolescents, this management is shared between the child and caregiver, and responsibility gradually shifts toward the child with increasing age and independence. This can create challenges related to adherence, diabetes-related distress, and caregiver burden.
DiaBuddy is an artificial intelligence (AI)-empowered digital self-management intervention developed to support children and adolescents with T1DM and their caregivers. The intervention is intended to complement, rather than replace, routine diabetes care. It provides digital tools for recording and reviewing diabetes-management information, educational content, reminders, motivational features, and caregiver support.
The application includes functions such as glucose logging and trend visualization, insulin and meal/snack reminders, physical activity reminders, hypoglycemia alerts, diabetes safety and diabetic ketoacidosis (DKA) education, educational videos, interactive quizzes, Urdu and English content, points, badges and rewards, caregiver dashboards, child-caregiver account linking, weekly summaries, synchronization, offline functionality where supported, and technical support.
DiaBuddy will also incorporate AI-supported analysis of available longitudinal diabetes-management information, such as glucose readings, insulin information, dietary information, physical activity information, and previous glucose patterns. The AI may provide individualized information concerning glucose trends, dietary considerations, physical activity, anticipated glucose patterns, diabetes-management reminders, and when medical review may be appropriate.
The AI component is designed as a decision-support and self-management tool. It will not independently change or administer insulin doses. Any insulin-related suggestion will remain subject to the participant's or caregiver's existing clinical management plan and treating clinician oversight. DiaBuddy will not replace treating physicians, routine diabetes care, emergency medical services, or clinical decision-making.
The definitive trial follows a preliminary DiaBuddy pilot. The pilot provided information about feasibility, usability, technical issues, questionnaire administration, recruitment, follow-up, and preliminary changes in self-management, caregiver burden, diabetes-related distress, and reported caregiving time. Because the pilot did not include a control group and was short in duration, it cannot determine whether observed changes were specifically attributable to DiaBuddy. The randomized controlled trial is therefore designed to provide a controlled comparison of DiaBuddy added to usual diabetes care versus usual diabetes care alone.
Participants will be followed for six months, with assessments planned at baseline, approximately three months, and approximately six months. Clinical and participant-reported information will be collected throughout follow-up. Laboratory-verified glycated hemoglobin (HbA1c) will be used to assess glycemic control. The study will also monitor relevant diabetes-related events and healthcare utilization, including hypoglycemia, severe hypoglycemia, DKA, emergency department visits, and diabetes-related hospitalization.
Safety monitoring will include potentially harmful AI outputs and technical failures that could affect participant safety in addition to clinical safety events. Participants will be informed that DiaBuddy is not an emergency service and that clinical emergencies should be managed through their treating healthcare team or appropriate emergency services.
Before the trial begins, the randomized controlled trial (RCT) version of the application will be documented, including the permitted and prohibited AI outputs, insulin-related safeguards, human oversight procedures, software and AI version control, handling of erroneous or incomplete information, and procedures for reporting potentially serious AI-related incidents. Changes to the software or AI system during the trial will be documented.
The trial is intended to determine whether adding DiaBuddy to usual diabetes care provides meaningful improvements in diabetes self-management and caregiver outcomes while also evaluating clinical outcomes, safety, usability, and engagement. The longer-term objective is to develop a safe and evidence-based digital self-management platform that may subsequently be evaluated for implementation within routine diabetes care in Pakistan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either DiaBuddy plus usual diabetes care or usual diabetes care alone. Participants will remain in their assigned group throughout the 6-month study period and will undergo assessments at baseline, approximately 3 months, and approximately 6 months. The study will compare changes in diabetes self-management/adherence, caregiver burden, and other prespecified clinical, behavioral, and safety outcomes between the two groups.
| Arm | Type | Receives |
|---|---|---|
| DiaBuddy + Usual Diabetes Care | Experimental | Behavioral: DiaBuddy: AI-Enabled Digital Self-Management InterventionParticipants assigned to this arm will receive access to DiaBuddy in addition to their usual diabetes care for 6 months. DiaBuddy is an AI-empowered digital self-management and decision-support intervention that provides tools for glucose logging and trend visualization, insulin, meal/snack, and physical activity reminders, hypoglycemia alerts, diabetes safety and DKA education, educational videos and quizzes, Urdu and English content, motivational features, caregiver support, and weekly summaries. The AI component may provide individualized self-management information and recommendations based on available diabetes-management information. DiaBuddy will not independently change or administer insulin doses and will not replace routine clinical care or emergency medical services. |
| Usual Care | Active comparator | Other: Usual Diabetes CareParticipants in this arm will receive usual standard diabetes care as provided by their treating healthcare team. They will not receive access to the DiaBuddy digital intervention during the study period. Usual care may include routine clinical follow-up, insulin therapy, blood glucose monitoring, dietary and physical-activity guidance, diabetes education, and other standard services according to the participant's treating team. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children and adolescents aged 6-17 years at the time of enrollment.
- Confirmed diagnosis of Type 1 diabetes mellitus for at least 6 months.
- Resident of Pakistan.
- Parent or primary caregiver actively involved in the participant's diabetes care and willing to participate in the study.
- Access to a compatible smartphone or digital device capable of running the DiaBuddy application.
Key exclusion criteria (6 listed)
- Cognitive, developmental, or other impairment that substantially limits the participant's ability to understand or use the intervention or complete study assessments.
- Severe or unstable medical illness that, in the judgment of the study investigator, would substantially interfere with study participation or follow-up.
- End-stage renal disease.
- Proliferative diabetic retinopathy.
- Recurrent severe diabetic ketoacidosis requiring intensive care that would substantially interfere with study participation or follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaBuddy: AI-Enabled Digital Self-Management InterventionDiaBuddy is an AI-enabled digital self-management intervention designed to support children aged 6-17 years with T1DM and their caregivers. The intervention provides tools for glucose logging and trend visualization, insulin and medication reminders, snack and exercise reminders, hypoglycemia and DKA educational alerts, diabetes education through videos, quizzes, cartoons and animations, and English and Urdu language options. It also includes points, badges and rewards to encourage engagement, caregiver-child linking, and a caregiver dashboard with weekly summaries. AI-supported features may assist with interpretation of glucose trends and provide general self-management recommendations; however, the system does not autonomously modify insulin doses, and insulin-related decisions remain under clinical supervision. Participants will use DiaBuddy alongside their usual diabetes care during the intervention period. | Behavioural | DiaBuddy + Usual Diabetes Care |
| Usual Diabetes CareParticipants assigned to the usual care arm will continue to receive standard diabetes care according to the routine practices of their treating healthcare team. Usual care may include routine clinical follow-up, insulin therapy, blood glucose monitoring, dietary and physical-activity counseling, diabetes education, and management of acute and chronic diabetes-related concerns as clinically indicated. Participants in this arm will not receive access to the DiaBuddy digital self-management intervention during the study period. | Other | Usual Care |
Primary outcome
Change in Child Diabetes Self-Management/Adherence Score
Time frame: Baseline and 6 months after randomization
Change in child diabetes self-management/adherence score assessed using the modified Self-Care Inventory-Revised (SCI-R). Higher scores indicate better self-management/adherence.
3 secondary outcomes
Change in Child Diabetes-Related Distress Score
Time frame: Baseline and 6 months after randomization
Change in Glycated Hemoglobin (HbA1c) Level
Time frame: Baseline and 6 months after randomization
Change in Diabetes-Related Caregiving Time
Time frame: Baseline and 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 36464988de Wit M, Gajewska KA, Goethals ER, McDarby V, Zhao X, Hapunda G, Delamater AM, DiMeglio LA. ISPAD Clinical Practice Consensus Guidelines 2022: Psychological care of children, adolescents and young adults with diabetes. Pediatr Diabetes. 2022 Dec;23(8):1373-1389. doi: 10.1111/pedi.13428. Epub 2022 Dec 5. No abstract available.
- Background: PubMed 36537528Tauschmann M, Forlenza G, Hood K, Cardona-Hernandez R, Giani E, Hendrieckx C, DeSalvo DJ, Laffel LM, Saboo B, Wheeler BJ, Laptev DN, Yarhere I, DiMeglio LA. ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Glucose monitoring. Pediatr Diabetes. 2022 Dec;23(8):1390-1405. doi: 10.1111/pedi.13451. No abstract available.
- Background: PubMed 36120721Lindholm Olinder A, DeAbreu M, Greene S, Haugstvedt A, Lange K, Majaliwa ES, Pais V, Pelicand J, Town M, Mahmud FH. ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes education in children and adolescents. Pediatr Diabetes. 2022 Dec;23(8):1229-1242. doi: 10.1111/pedi.13418. No abstract available.
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- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in the publication, after de-identification, may be shared with qualified researchers upon reasonable request. Data that could directly or indirectly identify participants will not be shared. Requests will be reviewed by the study investigators and will be subject to applicable ethical, privacy, and data-protection requirements. The shared dataset may include de-identified participant characteristics, intervention assignment, outcome measures, and relevant baseline and follow-up data. Data will be made available after publication of the primary study results, subject to appropriate data-use requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DiaBuddy: AI-Enabled Digital Self-Management Intervention and Usual Diabetes Care in people with Type 1 Diabetes Mellitus and Diabetes Self-Management Education, run by Dr. Juwayria Omar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Diabetes Self-Management/Adherence Score (time frame: Baseline and 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07861373, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.