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| Name | Class |
|---|---|
| District Diabetes Hospital, Dinajpur district of Bangladesh | UNKNOWN |
| Gausul Azam BNSB Eye Hospital in the Dinajpur district of Bangladesh | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| care recommendations | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | From enrollment to chart review (3 months after enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness, measured as total intervention cost per additional patient meeting the WHO blood sugar target. | Enrollment to chart review (3 months after enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lutful Husain | Contact | +8801711626852 | lutful.husain@orbis.org | |
| Nathan Congdon | Contact | +44 7748 751393 | ncongdon1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Munir Ahmed | Orbis Bangladesh | Principal Investigator |
| Nathan Congdon | Orbis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dinajpur Diabetes & Swasthoseba Hospital | Recruiting | Dinajpur Sadar | Dinajpur | 5200 | Bangladesh |
de-identified data will be shared upon reasonable request to the corresponding author
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
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| Gausul Azam BNSB Eye Hospital | Recruiting | Dinajpur District | Bangladesh |
|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |