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The proposed project is a clinical intervention trial testing the feasibility and effectiveness of diabetic retinopathy screening evaluated by artificial intelligence (AI) based software in children with type 1 diabetes (CwD). Another novel method, the confocal microscopy of the retina will be used to assess the early stages of diabetic neuropathy. In parallel, we aim to assess the prevalence of diabetic retinopathy and neuropathy in a well-controlled population of CwD at a tertiary diabetes care center.
Each participant will undergo an examination of diabetic retinopathy using the non-mydriatic fundus camera. The resulting photography will be evaluated by AI driven software. The participant will then follow this examinaton with fundus ophtalmoscopy in arteficial mydriasis as a standard method of diabetic retinopathy assessment. Another method, the optic coherence tomography (OCT), which is considered as the most sensitive method for diabetic retinopathy assessment, will be performed after that. The results of these methods will be compared to assess the sensitivity of each. The examination-satisfaction questionnaire will be given to the participants.
In subjects over 18 years, a confocal microscopy of the retina examination will be performed to assess the status of the corneal sub-basal nerve plexus and the presence of diabetic neuropathy will be noted.
The prevalence of diabetic retinopathy and neuropathy in this group of children with diabetes will be assessed based on the results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-mydriatic fundus camera photography | Diagnostic Test | Non-mydriatic fundus camera photography assessed by artificial intelligence software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of AI for retinopathy screening | The primary objective of this study is to test whether performing the diabetic retinopathy screening using the non-mydriatic fundus camera with AI software is feasible. The exact outcome is the percent of participants who will agree to undergo the procedure and will obtain a valid result (either positive or negative). | Through study completion, on average 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Examination satisfaction | Participant and caregiver reported examination satisfaction assessed by a structured questionnaire on a Lickert scale from 1 to 5. | Through study completion, on average 6 months. |
| Prevalence of diabetic retinopathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vit Neuman, MD, PhD | Contact | +420 224 432 090 | Vit.Neuman@fnmotol.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Motol | Prague | Prague 5 | 15006 | Czechia |
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| Fundus ophtalmoscopy | Diagnostic Test | Fundus opthalmoscopy assessed by an experienced ophtalmologist |
|
| Optic coherence tomography | Diagnostic Test | Optic coherence tomography assessed by an experienced ophtalmologist |
|
| Confocal microscopy of the retina | Diagnostic Test | In a subset of participants over 18 years of age, confocal microscopy of the retina will be performed to assess the presence of diabetic neuropathy |
|
Prevalence of diabetic retinopathy among CwD in a single center with favorable glucose control
| Through study completion, on average 6 months. |
| Prevalence of diabetic neuropathy | Prevalence of diabetic neuropathy in young people with diabetes (over 18 years) in a single center with favorable glucose control | Through study completion, on average 6 months. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003930 | Diabetic Retinopathy |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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