Effectiveness of UrDiaCare
UrDiaCare
1 other identifier
interventional
406
1 country
1
Brief Summary
The goal of this clinical trial is to learn if UrDiaCare, an Urdu-language diabetes support tool, can help adults with type 2 diabetes manage their Diabetes and improve blood sugar levels. The study will include adults aged 30 to 70 years with type 2 diabetes and higher-than-recommended blood sugar levels. The main question is whether UrDiaCare can lower HbA1c, a blood test that shows average blood sugar levels over the past few months, after four months. Researchers will compare UrDiaCare plus standard diabetes care with standard diabetes care plus a single Urdu educational pamphlet. UrDiaCare provides diabetes self-management education and support through WhatsApp/Android. It uses a fixed, health-professional-reviewed information library and does not provide diagnosis or prescribe treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Sep 2026
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
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
September 4, 2026
CompletedFirst Posted
Study publicly available on registry
September 11, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
September 21, 2026
September 1, 2026
4 months
September 4, 2026
September 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (%) from baseline to 4 months
Glycated hemoglobin (HbA1c) will be measured as an indicator of glycemic control at baseline and at 4 months. The primary analysis will compare the change in HbA1c from baseline to 4 months between the Urdiacare mHealth chatbot intervention group and the control group.
Baseline to 4 Months
Secondary Outcomes (3)
Change in Diabetes Self-Management Questionnaire (DSMQ) score from baseline to 4 months
Baseline, 2 months, and 4 months after randomization
Change in Urdu Diabetes Self-Efficacy Scale (U-DSES) score
Baseline and 4 months after randomization
Change in Urdu Summary of Diabetes Self-Care Activities (U-SDSCA) score
Baseline, 2 months, and 4 months after randomization
Study Arms (2)
UrDiaCare
EXPERIMENTALParticipants randomized to this arm will receive UrDiaCare, a knowledge-grounded retrieval-augmented generation (RAG) Urdu large language model self-management assistant, delivered via WhatsApp/Android for 4 months in addition to standard outpatient diabetes care. UrDiaCare provides interactive Urdu diabetes self-management education and support covering glucose monitoring, medication management, diet, physical activity, and foot care. The system uses a predefined, clinician-reviewed knowledge base and provides scope-limited educational responses.
Urdu Educational Pamphlet
ACTIVE COMPARATORParticipants randomized to this arm will receive standard outpatient diabetes care plus a single, non-interactive Urdu educational pamphlet delivered once at baseline via WhatsApp. The pamphlet covers the same five diabetes self-management domains as the UrDiaCare content library: glucose monitoring, medication management, diet, physical activity, and foot care. The pamphlet is static and does not provide interactive or ongoing conversational support.
Interventions
UrDiaCare is a knowledge-grounded, retrieval-augmented generation (RAG)-based Urdu large language model self-management application delivered through WhatsApp/Android. It provides interactive Urdu diabetes self-management education and support for 4 months in addition to standard outpatient diabetes care. The intervention covers glucose monitoring, medication management, diet, physical activity, and foot care. UrDiaCare uses a predefined, clinician-reviewed, version-locked knowledge library and a safety-scope check. The system provides structured educational responses and scope-limited replies, and redirects out-of-scope requests requiring individualized clinical advice to the participant's treating physician or appropriate health facility.
Participants will receive standard outpatient diabetes care plus a single, non-interactive Urdu educational pamphlet delivered online via WhatsApp at baseline. The pamphlet provides general diabetes self-management education covering five domains: blood glucose monitoring, medication adherence, healthy eating, physical activity, and foot care. It does not provide interactive, personalized, or ongoing support.
Eligibility Criteria
You may qualify if:
- Adults aged 30-70 years with T2DM confirmed ≥ 6 months (clinical record) and HbA1c ≥ 7.5% at screening
- Currently prescribed oral antidiabetic medication(s) for ≥ 3 months
- Personal ownership and regular daily use of a functioning smartphone (Android/iOS)
- Able to read and understand Urdu
- Available for the full 4-month study period and willing to provide written informed consent -
You may not qualify if:
- Type 1, gestational, or secondary diabetes (e.g., steroid-induced, MODY)
- Current insulin therapy (to avoid confounding from differing self-management complexity)
- Severe, uncorrectable comorbidity likely to materially affect glycemic control or survival within 4 months (e.g., end-stage renal disease, active malignancy, liver failure)
- Significant cognitive impairment or psychiatric disorder precluding informed consent or technology use
- Participation in another diabetes clinical trial within the preceding 3 months
- Insufficient Urdu reading proficiency, as the UrDiaCare interface is Urdu-script based
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
District Headquarter Hospital
Gujranwala, Punjab Province, 52250, Pakistan
Related Publications (1)
Arshed M, Mahmud A, Minhat HS, Lim PY, Zakar R. Effectiveness of a Multifaceted Mobile Health Intervention (Multi-Aid-Package) in Medication Adherence and Treatment Outcomes Among Patients With Hypertension in a Low- to Middle-Income Country: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jun 19;12:e50248. doi: 10.2196/50248.
PMID: 38896837BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor responsible for collecting or assessing study outcomes will be blinded to participants' treatment allocation. Participants and intervention personnel will not be blinded because of the nature of the intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department Pubic Health, AFPGMI
Study Record Dates
First Submitted
September 4, 2026
First Posted
September 11, 2026
Study Start
September 15, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
September 21, 2026
Record last verified: 2026-09