Health TrialsbyHealthPanel

Effectiveness of UrDiaCare

ConditionDiabetes Mellitus Type 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorNational University of Medical Sciences, Pakistan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 -

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • UrDiaCare

    Behavioral

    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.

  • Urdu Educational Pamphlet

    Behavioral

    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.

Treatment groups

406 Participants
are divided into 2 treatment groups
Group A: UrDiaCareExperimental treatment 1 intervention
Group B: Urdu Educational PamphletActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to 4 Months

Secondary outcomes

1

Change in Diabetes Self-Management Questionnaire (DSMQ) score from baseline to 4 months

The Diabetes Self-Management Questionnaire (DSMQ) will be used to assess diabetes self-management behaviors. The total DSMQ score will be measured at baseline, 2 months, and 4 months. Changes in scores over time will be compared between the intervention and control groups

Time frame
Baseline, 2 months, and 4 months after randomization
2

Change in Urdu Diabetes Self-Efficacy Scale (U-DSES) score

The Urdu Diabetes Self-Efficacy Scale (U-DSES) will be used to assess participants' confidence in managing their diabetes. The total self-efficacy score will be assessed at baseline and at 4 months, and the change in score will be compared between the intervention and control groups.

Time frame
Baseline and 4 months after randomization
3

Change in Urdu Summary of Diabetes Self-Care Activities (U-SDSCA) score

The Urdu Summary of Diabetes Self-Care Activities (U-SDSCA) will be used to assess diabetes self-care behaviors, including dietary practices, physical activity, blood glucose testing, medication adherence, and foot care. The score will be assessed at baseline, 2 months, and 4 months, and changes over time will be compared between the intervention and control groups.

Time frame
Baseline, 2 months, and 4 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Medical Sciences, Pakistan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: