Diabetes Mellitus Type 2UrDiaCareNCT07814742
Effectiveness of UrDiaCare
A study testing UrDiaCare and Urdu Educational Pamphlet in people with Diabetes Mellitus Type 2, run by National University of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- UrDiaCare and Urdu Educational Pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2026to 31 Jan 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
District Headquarter Hospital
Gujranwala, Punjab Province, 52250
About this study
Official title: Effectiveness of UrDiaCare: A Knowledge-Grounded Urdu Large Language Diabetes Management Application on Glycaemic Control Self Management Among Adults With Type 2 Diabetes in Pakistan: A Randomised Controlled 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.
Read the detailed description
This study evaluates UrDiaCare, an Urdu-language, knowledge-grounded conversational assistant developed to support diabetes self-management among adults with type 2 diabetes in Pakistan. The intervention is designed to complement routine diabetes care by providing accessible, culturally appropriate education and ongoing support through WhatsApp.
UrDiaCare focuses on five areas of diabetes self-management: medication adherence, healthy eating, physical activity, blood glucose monitoring, and prevention of diabetes-related complications. Its development includes translating and culturally adapting diabetes education materials, expert review, and pilot testing with adults with type 2 diabetes to assess clarity, usability, cultural appropriateness, and technical functionality before finalizing the intervention.
The intervention is guided by Social Cognitive Theory (SCT) and the Health Belief Model (HBM). SCT emphasizes self-efficacy and supports mastery experiences, encouragement, and contextualized feedback. HBM informs messages addressing perceived susceptibility, severity, benefits, and barriers related to diabetes self-management. The conceptual framework proposes that UrDiaCare may improve self-efficacy and health beliefs, leading to better medication adherence and self-care behaviors and, ultimately, improved glycemic control.
UrDiaCare uses a knowledge-grounded, retrieval-augmented approach. Its responses are restricted to a predefined, clinician-reviewed knowledge library based on established diabetes education resources. The system is not a diagnostic or prescribing tool and does not provide individualized medical recommendations. Questions outside its approved educational scope trigger a standard response directing participants to their treating physician or an appropriate health facility. The knowledge library and safety rules are version-locked during the trial to maintain consistency.
The trial will use a parallel-group randomized controlled design. Participants will receive either UrDiaCare in addition to standard outpatient diabetes care or standard care with a static Urdu educational pamphlet covering the same five self-management areas. The study will follow participants for four months, with assessments conducted at baseline, two months, and four months.
The primary outcome is change in HbA1c from baseline to four months. Secondary outcomes assess medication adherence, diabetes self-management behavior, diabetes self-efficacy, self-care behaviors, and the usability and acceptability of UrDiaCare. The study will also examine factors associated with glycemic improvement among participants receiving UrDiaCare.
Intervention engagement and technical performance will be monitored throughout the study. UrDiaCare will use predefined safety checks to identify emergency or out-of-scope requests, while system information will be used to assess engagement and intervention delivery. Participant confidentiality will be protected through secure data-handling procedures, with identifying information and communication records stored separately and access restricted to authorized study personnel.
Overall, the study will determine whether adding a theory-informed, Urdu-language, knowledge-grounded conversational intervention to standard diabetes care can improve glycemic control and diabetes self-management. It will also provide evidence on the usability and safe implementation of an AI-assisted approach to diabetes self-management in Pakistan.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- UrDiaCare, Urdu Educational Pamphlet
- Keywords
- Diabetes self-management, Glycemic control, Type 2 Diabetes Mellitus, Conversational artificial intelligence, Diabetes Self-Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrDiaCareBehavioural
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 PamphletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| UrDiaCare | Experimental | Participants 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. Receives: Behavioral: UrDiaCare |
| Urdu Educational Pamphlet | Active comparator | Participants 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. Receives: Behavioral: Urdu Educational Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 Months
Secondary outcomes (3)
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
Measured: Baseline, 2 months, and 4 months after randomization
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.
Measured: Baseline and 4 months after randomization
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.
Measured: Baseline, 2 months, and 4 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 posted11 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Medical Sciences, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Shamaila Mohsin, PhD, National University of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814742
- Sponsor's protocol ID
- Re:758-AAA-ERC-AFPGMI
- Acronym
- UrDiaCare
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38896837
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of UrDiaCare: A Knowledge-Grounded Urdu Large Language Diabetes Management Application on Glycaemic Control Self Management Among Adults With Type 2 Diabetes in Pakistan: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07814742
- Acronym / sponsor ID
- UrDiaCare / Re:758-AAA-ERC-AFPGMI
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes self-management, Glycemic control, Type 2 Diabetes Mellitus, Conversational artificial intelligence, Diabetes Self-Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- National University of Medical Sciences, PakistanUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Sep 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 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.
Detailed description
This study evaluates UrDiaCare, an Urdu-language, knowledge-grounded conversational assistant developed to support diabetes self-management among adults with type 2 diabetes in Pakistan. The intervention is designed to complement routine diabetes care by providing accessible, culturally appropriate education and ongoing support through WhatsApp.
UrDiaCare focuses on five areas of diabetes self-management: medication adherence, healthy eating, physical activity, blood glucose monitoring, and prevention of diabetes-related complications. Its development includes translating and culturally adapting diabetes education materials, expert review, and pilot testing with adults with type 2 diabetes to assess clarity, usability, cultural appropriateness, and technical functionality before finalizing the intervention.
The intervention is guided by Social Cognitive Theory (SCT) and the Health Belief Model (HBM). SCT emphasizes self-efficacy and supports mastery experiences, encouragement, and contextualized feedback. HBM informs messages addressing perceived susceptibility, severity, benefits, and barriers related to diabetes self-management. The conceptual framework proposes that UrDiaCare may improve self-efficacy and health beliefs, leading to better medication adherence and self-care behaviors and, ultimately, improved glycemic control.
UrDiaCare uses a knowledge-grounded, retrieval-augmented approach. Its responses are restricted to a predefined, clinician-reviewed knowledge library based on established diabetes education resources. The system is not a diagnostic or prescribing tool and does not provide individualized medical recommendations. Questions outside its approved educational scope trigger a standard response directing participants to their treating physician or an appropriate health facility. The knowledge library and safety rules are version-locked during the trial to maintain consistency.
The trial will use a parallel-group randomized controlled design. Participants will receive either UrDiaCare in addition to standard outpatient diabetes care or standard care with a static Urdu educational pamphlet covering the same five self-management areas. The study will follow participants for four months, with assessments conducted at baseline, two months, and four months.
The primary outcome is change in HbA1c from baseline to four months. Secondary outcomes assess medication adherence, diabetes self-management behavior, diabetes self-efficacy, self-care behaviors, and the usability and acceptability of UrDiaCare. The study will also examine factors associated with glycemic improvement among participants receiving UrDiaCare.
Intervention engagement and technical performance will be monitored throughout the study. UrDiaCare will use predefined safety checks to identify emergency or out-of-scope requests, while system information will be used to assess engagement and intervention delivery. Participant confidentiality will be protected through secure data-handling procedures, with identifying information and communication records stored separately and access restricted to authorized study personnel.
Overall, the study will determine whether adding a theory-informed, Urdu-language, knowledge-grounded conversational intervention to standard diabetes care can improve glycemic control and diabetes self-management. It will also provide evidence on the usability and safe implementation of an AI-assisted approach to diabetes self-management in Pakistan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UrDiaCare | Experimental | Behavioral: UrDiaCareParticipants 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 comparator | Behavioral: Urdu Educational PamphletParticipants 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| UrDiaCareUrDiaCare 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. | Behavioural | UrDiaCare |
| Urdu Educational PamphletParticipants 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. | Behavioural | Urdu Educational Pamphlet |
Primary outcome
Change in HbA1c (%) from baseline to 4 months
Time frame: 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.
3 secondary outcomes
Change in Diabetes Self-Management Questionnaire (DSMQ) score from baseline to 4 months
Time frame: Baseline, 2 months, and 4 months after randomization
Change in Urdu Diabetes Self-Efficacy Scale (U-DSES) score
Time frame: Baseline and 4 months after randomization
Change in Urdu Summary of Diabetes Self-Care Activities (U-SDSCA) score
Time frame: Baseline, 2 months, and 4 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 21 Sep 2026.
- Background: PubMed 38896837Arshed 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UrDiaCare and Urdu Educational Pamphlet in people with Diabetes Mellitus Type 2, run by National University of Medical Sciences, Pakistan at 1 site in Pakistan.
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 5 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Areeba Noor, MS Public Health (03000143378, areeban72@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (%) from baseline to 4 months (time frame: Baseline to 4 Months). 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 NCT07814742, which also lists 1 linked publication.
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 21 Sep 2026.