Diabetes MellitusNCT06968611
Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Demand Side
A study testing Education/information of risk and Free eye glasses in people with Diabetes Mellitus and Diabetic Retinopathy (DR), run by Orbis at 2 sites in Bangladesh.
Trial summary
The goal of this clinical trial is to determine whether there is an increase in participant uptake of diabetes mellitus (DM) and diabetic retinopathy (DR) services and improved quality of patient-centered diabetic care resulting from the use of automated voice message reminders to sensitize people with DM about the… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy (DR)
- What is being tested?
- Education/information of risk and Free eye glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesBangladesh
- Study dates
- 25 Aug 2025to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with DM within the last 6 months
- Over 30 years of age
- Currently treated at the Dinajpur Diabetes Hospital
- Possess a mobile phone to receive voice messages
- Willingness to participate in the study, and ability to give informed consent
Who cannot join
- Other significant causes of vision loss
- Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh2 sites, 2 recruiting
- Recruiting
Gausul Azam BNSB Eye Hospital
Dinajpur
Gausul Azam BNSB Eye Hospital, +8802589934033, bnsbdinajpur@gmail.com
- Recruiting
Dinajpur Diabetes & Swasthoseba Hospital
Dinajpur Sadar
Diabetic Association, Dinajpur, +8802588817827, dinajpur.diabetes@gmail.com
About this study
The goal of this clinical trial is to determine whether there is an increase in participant uptake of diabetes mellitus (DM) and diabetic retinopathy (DR) services and improved quality of patient-centered diabetic care resulting from the use of automated voice message reminders to sensitize people with DM about the potential for sight loss alongside the provision of free reading glasses.
The main questions it aims to answer are:
- Will the proportion of patients completing their scheduled DR and DM appointments within 3 weeks of the scheduled date be significantly increased in the group receiving the automated voice messages containing both appointment reminders and messaging about the importance of visit and medication compliance in reducing the risk of vision loss, compared with participant messages which only remind them of their appointments?
- What is the cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam?
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy (DR)
- Being tested
- Education/information of risk, Free eye glasses
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education/information of riskOther
Participant will receive a message underscoring risk of vision loss from poorly controlled DM, and how this risk can be largely eliminated with excellent compliance with mediations and clinical visits.
Free eye glassesOther
Participants will receive a free pair of reading glass at their first appointment
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Automated voice message exam reminder only | No intervention | Participants will only receive an automated voice message reminder about the date of exam |
| Intervention Group: Automated voice message + vision education + free reading glasses at appointment | Experimental | Participants will receive an automated voice message reminder about the date of the exam. Additionally, the participant will receive a message underscoring the risk of vision loss from poorly controlled DM, stressing that excellent compliance with visits and medications nearly completely eliminates this risk, and the participant will receive a free pair of reading glasses on first appointment. Receives: Other: Education/information of risk; Other: Free eye glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients completing their diabetes or DR exam within 3 weeks of the scheduled date.
Measured: 3 weeks following scheduled exam date
Secondary outcomes (1)
Cost-effectiveness, measured as total intervention cost per additional patient adherence with the suggested exam.
Measured: Enrollment to 3 weeks following suggested exam date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orbis
- Sponsor type
- University, hospital or other
- Collaborators
- District Diabetes Hospital, Dinajpur district of Bangladesh, Gausul Azam BNSB Eye Hospital, Dinajpur district of Bangladesh
- Responsible party
- Sponsor
- Investigators
- Munir Ahmed, Principal investigator, Orbis BangladeshNathan Congdon, Principal investigator, Orbis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968611
- Sponsor's protocol ID
- PIS-DR-DEMAND-2025
- Status last verified
- Oct 2026
- First submitted
- 5 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data is available upon reasonable request to the corresponding author following the study completion
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Demand Side
- ClinicalTrials.gov ID
- NCT06968611
- Acronym / sponsor ID
- PIS-DR-DEMAND-2025
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy (DR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- OrbisUniversity, hospital or other
- Collaborators
- District Diabetes Hospital, Dinajpur district of Bangladesh, Gausul Azam BNSB Eye Hospital, Dinajpur district of Bangladesh
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 2025 (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 determine whether there is an increase in participant uptake of diabetes mellitus (DM) and diabetic retinopathy (DR) services and improved quality of patient-centered diabetic care resulting from the use of automated voice message reminders to sensitize people with DM about the potential for sight loss alongside the provision of free reading glasses.
The main questions it aims to answer are:
- Will the proportion of patients completing their scheduled DR and DM appointments within 3 weeks of the scheduled date be significantly increased in the group receiving the automated voice messages containing both appointment reminders and messaging about the importance of visit and medication compliance in reducing the risk of vision loss, compared with participant messages which only remind them of their appointments?
- What is the cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Automated voice message exam reminder only | No intervention | –Participants will only receive an automated voice message reminder about the date of exam |
| Intervention Group: Automated voice message + vision education + free reading glasses at appointment | Experimental | Other: Education/information of risk, Other: Free eye glassesParticipants will receive an automated voice message reminder about the date of the exam. Additionally, the participant will receive a message underscoring the risk of vision loss from poorly controlled DM, stressing that excellent compliance with visits and medications nearly completely eliminates this risk, and the participant will receive a free pair of reading glasses on first appointment. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with DM within the last 6 months
- Over 30 years of age
- Currently treated at the Dinajpur Diabetes Hospital
- Possess a mobile phone to receive voice messages
- Willingness to participate in the study, and ability to give informed consent
Key exclusion criteria (2 listed)
- Other significant causes of vision loss
- Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
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 |
|---|---|---|
| Education/information of riskParticipant will receive a message underscoring risk of vision loss from poorly controlled DM, and how this risk can be largely eliminated with excellent compliance with mediations and clinical visits. | Other | Intervention Group: Automated voice message + vision education + free reading glasses at appointment |
| Free eye glassesParticipants will receive a free pair of reading glass at their first appointment | Other | Intervention Group: Automated voice message + vision education + free reading glasses at appointment |
Primary outcome
Proportion of patients completing their diabetes or DR exam within 3 weeks of the scheduled date.
Time frame: 3 weeks following scheduled exam date
1 secondary outcome
Cost-effectiveness, measured as total intervention cost per additional patient adherence with the suggested exam.
Time frame: Enrollment to 3 weeks following suggested exam date
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 22 Oct 2026.
- Individual participant dataSharing planned: Yes. de-identified data is available upon reasonable request to the corresponding author following the study completion
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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.
Munir Ahmed principal investigator
Orbis Bangladesh
Nathan Congdon principal investigator
Orbis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education/information of risk and Free eye glasses in people with Diabetes Mellitus and Diabetic Retinopathy (DR), run by Orbis at 2 sites in Bangladesh.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. 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 Lutful Husain (+88 01711626852, lutful.husain@orbis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients completing their diabetes or DR exam within 3 weeks of the scheduled date. (time frame: 3 weeks following scheduled exam date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.