Diabetes MellitusNCT06968637
Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Supply Side
A study testing care recommendations 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 integration of vision care into the DM treatment system, by providing specific recommendations to doctors for management of diabetes alongside feedback on positive eye exams for DR can improve diabetes care outcomes. The main questions it aims to answer are: 1. 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?
- care recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 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
- Diagnosed with DR in at least one eye
- Over 30 years of age
- Currently treated at the Dinajpur Diabetes Hospital and Gausul Azam BNSB Eye Hospital in Bangladesh
- willingness to participate in the study
Who cannot join
- Any ocular condition impairing the view of the fundus sufficiently to preclude grading of the image for DR.
- Inability to comply with retinal photography to the extent that a gradable image cannot be captured, or any other factor leading to absence of sufficient images to grade at least one eye of a participant.
- Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
- Unwilling to participate in the study, or incapable of giving informed consent.
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 District
Gausul Azam BNSB Eye Hospital, +8802589934033, bnsbdinajpur@gmail.com
- Recruiting
Dinajpur Diabetes & Swasthoseba Hospital
Dinajpur Sadar, Dinajpur, 5200
Diabetic Association, Dinajpur, +8802588817827, dinajpur.diabetes@gmail.com
About this study
The goal of this clinical trial is to determine whether integration of vision care into the DM treatment system, by providing specific recommendations to doctors for management of diabetes alongside feedback on positive eye exams for DR can improve diabetes care outcomes.
The main questions it aims to answer are:
Read more
- Does delivery of specific diabetes management recommendations to diabetes doctors for patients of theirs found to have DR lead to significantly improved blood glucose control as indicated by % reaching WHO targets of HbA1c (or targets for blood sugar if HbA1c data are unavailable)?
- What is the cost-effectiveness of the intervention, measured as total intervention cost per additional participant reaching the WHO target?
Researchers will compare participant adherence with international guidelines when DR results are provided by a PIS without specific care recommendations to when the PIS provides DR results with specific care recommendations for DM management.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy (DR)
- Being tested
- care recommendations
- 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.
care recommendationsOther
Also called Specific DM care recommendations
Provision of specific care recommendations for diabetes management. Based on existing guidelines, when any DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Only DR results provided | No intervention | For these participants, the patient information system (PIS) will send only diabetic retinopathy (DR) results to the Diabetologist at the diabetic hospital without specific care recommendations |
| Intervention Group: DR results + care recommendations for DM management provided | Experimental | For these participants, the patient information system (PIS) will send DR results to the Diabetologist at the diabetic hospital along with specific care recommendations for diabetes management (only for those patients with ANY DR) Receives: Other: care recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants reaching WHO target HbA1c levels of <= 7.0% (or WHO blood sugar targets if HbA1c data are unavailable) among participants with any DR, upon chart review by a masked clinician observer, compared between study groups.
According to the World Health Organization (WHO), the specific HgA1c target is <= 7.0%
Measured: From enrollment to chart review (3 months after enrollment)
Secondary outcomes (1)
Cost-effectiveness, measured as total intervention cost per additional patient meeting the WHO blood sugar target.
Measured: Enrollment to chart review (3 months after enrollment)
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
- Model description
- Cluster-randomised design, with diabetologist as the cluster. In the intervention group, a Patient Information System (PIS) database will be used, both at the diabetic hospital and eye hospital in Dinajpur. The PIS will be used for referral tracking, to deliver the results of the eye exam to the diabetologist, and, most importantly, based on the result of the DR exam, to provide specific care recommendations for diabetes management. Based on existing guidelines, when DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids. Therefore, through the doctors of the diabetic hospital tracking eye results, the PIS will reinforce the need for the patient to visit both the eye hospital and diabetic hospital for DM/DR management and will improve overall DM care. In the Control group, information on the DR exam will be conveyed through the PIS without specific care recommendations.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 336 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 in the 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
- NCT06968637
- Sponsor's protocol ID
- PIS-DR-SUPPLY-2025
- Status last verified
- Oct 2026
- First submitted
- 5 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data will be shared upon reasonable request to the corresponding author
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 Supply Side
- ClinicalTrials.gov ID
- NCT06968637
- Acronym / sponsor ID
- PIS-DR-SUPPLY-2025
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy (DR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- OrbisUniversity, hospital or other
- Collaborators
- District Diabetes Hospital, Dinajpur district of Bangladesh, Gausul Azam BNSB Eye Hospital in the 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 integration of vision care into the DM treatment system, by providing specific recommendations to doctors for management of diabetes alongside feedback on positive eye exams for DR can improve diabetes care outcomes.
The main questions it aims to answer are:
- Does delivery of specific diabetes management recommendations to diabetes doctors for patients of theirs found to have DR lead to significantly improved blood glucose control as indicated by % reaching WHO targets of HbA1c (or targets for blood sugar if HbA1c data are unavailable)?
- What is the cost-effectiveness of the intervention, measured as total intervention cost per additional participant reaching the WHO target?
Researchers will compare participant adherence with international guidelines when DR results are provided by a PIS without specific care recommendations to when the PIS provides DR results with specific care recommendations for DM management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomised design, with diabetologist as the cluster. In the intervention group, a Patient Information System (PIS) database will be used, both at the diabetic hospital and eye hospital in Dinajpur. The PIS will be used for referral tracking, to deliver the results of the eye exam to the diabetologist, and, most importantly, based on the result of the DR exam, to provide specific care recommendations for diabetes management. Based on existing guidelines, when DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids. Therefore, through the doctors of the diabetic hospital tracking eye results, the PIS will reinforce the need for the patient to visit both the eye hospital and diabetic hospital for DM/DR management and will improve overall DM care. In the Control group, information on the DR exam will be conveyed through the PIS without specific care recommendations.
| Arm | Type | Receives |
|---|---|---|
| Control Group: Only DR results provided | No intervention | –For these participants, the patient information system (PIS) will send only diabetic retinopathy (DR) results to the Diabetologist at the diabetic hospital without specific care recommendations |
| Intervention Group: DR results + care recommendations for DM management provided | Experimental | Other: care recommendationsFor these participants, the patient information system (PIS) will send DR results to the Diabetologist at the diabetic hospital along with specific care recommendations for diabetes management (only for those patients with ANY DR) |
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
- Diagnosed with DR in at least one eye
- Over 30 years of age
- Currently treated at the Dinajpur Diabetes Hospital and Gausul Azam BNSB Eye Hospital in Bangladesh
- willingness to participate in the study
Key exclusion criteria (4 listed)
- Any ocular condition impairing the view of the fundus sufficiently to preclude grading of the image for DR.
- Inability to comply with retinal photography to the extent that a gradable image cannot be captured, or any other factor leading to absence of sufficient images to grade at least one eye of a participant.
- Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
- Unwilling to participate in the study, or incapable of giving informed consent.
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 |
|---|---|---|
| care recommendationsAlso: Specific DM care recommendationsProvision of specific care recommendations for diabetes management. Based on existing guidelines, when any DR is present, the PIS will prompt diabetologists to check, and if necessary, change medicines to optimize, blood sugar, blood pressure and lipids. | Other | Intervention Group: DR results + care recommendations for DM management provided |
Primary outcome
The proportion of participants reaching WHO target HbA1c levels of <= 7.0% (or WHO blood sugar targets if HbA1c data are unavailable) among participants with any DR, upon chart review by a masked clinician observer, compared between study groups.
Time frame: From enrollment to chart review (3 months after enrollment)
According to the World Health Organization (WHO), the specific HgA1c target is <= 7.0%
1 secondary outcome
Cost-effectiveness, measured as total intervention cost per additional patient meeting the WHO blood sugar target.
Time frame: Enrollment to chart review (3 months after enrollment)
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 will be shared upon reasonable request to the corresponding author
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 care recommendations 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 4 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 (+8801711626852, lutful.husain@orbis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants reaching WHO target HbA1c levels of <= 7.0% (or WHO blood sugar targets if HbA1c data are unavailable) among participants with any DR, upon chart review by a masked clinician observer, compared between study groups. (time frame: From enrollment to chart review (3 months after enrollment)). 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.