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
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