DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes (DiaBuddy)
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:
- 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: DiaBuddy + Usual Diabetes Care
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. |
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. |
|
Aktiver Komparator: Usual Care
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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Child Diabetes Self-Management/Adherence Score
Zeitfenster: 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. |
Baseline and 6 months after randomization
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Child Diabetes-Related Distress Score
Zeitfenster: Baseline and 6 months after randomization
|
Change in diabetes-related distress assessed using the study's specified child distress measure/emoji-based assessment. Lower scores indicate lower diabetes-related distress. |
Baseline and 6 months after randomization
|
|
Change in Glycated Hemoglobin (HbA1c) Level
Zeitfenster: Baseline and 6 months after randomization
|
Change in glycated hemoglobin (HbA1c), measured as a clinical indicator of glycemic control. |
Baseline and 6 months after randomization
|
|
Change in Diabetes-Related Caregiving Time
Zeitfenster: Baseline and 6 months after randomization
|
Change in caregiver-reported time spent on diabetes-related caregiving activities, reported in hours per day. Lower values indicate reduced caregiving time. |
Baseline and 6 months after randomization
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants With Diabetes-Related Adverse Events
Zeitfenster: Throughout the 6-month intervention period
|
Occurrence of hypoglycemia, severe hypoglycemia, diabetic ketoacidosis (DKA), emergency department visits, and diabetes-related hospitalizations will be recorded and compared between study arms. |
Throughout the 6-month intervention period
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Weinger 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.
- Goyal 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.
- Azimi 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.
- 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.
- Tauschmann 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.
- Lindholm 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.
- Cejalvo 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.
- Feldman 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.
- Rubab 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.
- Zhang 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.
- Rostaminasab 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.
- Carrigan 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.
- Jawad 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.
- Jabeen 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.
- Ahmedani MY, Fawwad A, Shaheen F, Tahir B, Waris N, Basit A. Optimized health care for subjects with type 1 diabetes in a resource constraint society: A three-year follow-up study from Pakistan. World J Diabetes. 2019 Mar 15;10(3):224-233. doi: 10.4239/wjd.v10.i3.224.
- Xie J, Li W, Li X, Zhang X, Liu J, Liu Z, Jing S, Shao H. Global, regional, and national epidemiology of type 1 diabetes in children from 1990 to 2021: trend and health inequality analyses based on the Global Burden of Disease Study 2021. Diabetol Metab Syndr. 2025 Aug 18;17(1):337. doi: 10.1186/s13098-025-01905-3.
- Bell KJ, Lain SJ. The Changing Epidemiology of Type 1 Diabetes: A Global Perspective. Diabetes Obes Metab. 2025 Aug;27 Suppl 6(Suppl 6):3-14. doi: 10.1111/dom.16501. Epub 2025 Jun 19.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des endokrinen Systems
- Stoffwechselerkrankungen
- Autoimmunerkrankungen
- Erkrankungen des Immunsystems
- Verhaltenssymptome
- Störungen des Glukosestoffwechsels
- Diabetes Mellitus
- Stress, Psychisch
- Verhalten
- Ernährungs- und Stoffwechselerkrankungen
- Belastung der Pflegekraft
- Diabetes mellitus, Typ 1
Andere Studien-ID-Nummern
- DIABUDDY-RCT-2026
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
IPD will be available beginning 12 months after publication of the primary study results and will remain available for 5 years. Supporting information will be available during the same period.
IPD-Sharing-Zugriffskriterien
Access will be available to qualified researchers who submit a reasonable request for scientifically valid research purposes. Requests will be reviewed by the study investigators and must comply with applicable ethical, privacy, and data-protection requirements. Approved researchers will receive access to relevant de-identified individual participant data and selected supporting documents through a secure data-sharing process. Data will not be provided in a form that permits participant identification.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .