Type 1 Diabetes MellitusPAIRS-T1DNCT07149142
Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes
A study testing Non-mydriatic fundus camera photography, Fundus ophtalmoscopy and Optic coherence tomography in people with Type 1 Diabetes Mellitus, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Non-mydriatic fundus camera photography, Fundus ophtalmoscopy and Optic coherence tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2026to 31 Dec 2029
- 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 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes diagnosed according to the ADA criteria
- Age over 11.0 years or duration of diabetes over 2 years
- Signed written informed consent by both the CwD and their parent/caregiver
Who cannot join
- Unwillingness to sign a written informed consent by both the CwD and their parent/caregiver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Motol
Prague, Prague 5, 15006
Vit Neuman, MD, PhD, +420224432090, Vit.Neuman@fnmotol.cz
About this study
Official title: Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes
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.
Read more
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Non-mydriatic fundus camera photography, Fundus ophtalmoscopy, Optic coherence tomography, Confocal microscopy of the retina
- Keywords
- Diabetic Retinopathy, Diabetic Neuropathy, Artificial Intelligence
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-mydriatic fundus camera photographyDiagnostic test
Non-mydriatic fundus camera photography assessed by artificial intelligence software
Fundus ophtalmoscopyDiagnostic test
Fundus opthalmoscopy assessed by an experienced ophtalmologist
Optic coherence tomographyDiagnostic test
Optic coherence tomography assessed by an experienced ophtalmologist
Confocal microscopy of the retinaDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Non-mydriatic fundus camera photography; Diagnostic Test: Fundus ophtalmoscopy; Diagnostic Test: Optic coherence tomography; Diagnostic Test: Confocal microscopy of the retina |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, on average 6 months.
Secondary outcomes (3)
Examination satisfaction
Participant and caregiver reported examination satisfaction assessed by a structured questionnaire on a Lickert scale from 1 to 5.
Measured: Through study completion, on average 6 months.
Prevalence of diabetic retinopathy
Prevalence of diabetic retinopathy among CwD in a single center with favorable glucose control
Measured: 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
Measured: Through study completion, on average 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vit Neuman, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149142
- Sponsor's protocol ID
- PAIRS
- Acronym
- PAIRS-T1D
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07149142
- Acronym / sponsor ID
- PAIRS-T1D / PAIRS
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetic Retinopathy, Diabetic Neuropathy, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Aug 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Diagnostic Test: Non-mydriatic fundus camera photography, Diagnostic Test: Fundus ophtalmoscopy, Diagnostic Test: Optic coherence tomography, Diagnostic Test: Confocal microscopy of the retinaAll 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. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Type 1 diabetes diagnosed according to the ADA criteria
- Age over 11.0 years or duration of diabetes over 2 years
- Signed written informed consent by both the CwD and their parent/caregiver
Key exclusion criteria (1 listed)
- Unwillingness to sign a written informed consent by both the CwD and their parent/caregiver
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 |
|---|---|---|
| Non-mydriatic fundus camera photographyNon-mydriatic fundus camera photography assessed by artificial intelligence software | Diagnostic test | Study arm |
| Fundus ophtalmoscopyFundus opthalmoscopy assessed by an experienced ophtalmologist | Diagnostic test | Study arm |
| Optic coherence tomographyOptic coherence tomography assessed by an experienced ophtalmologist | Diagnostic test | Study arm |
| Confocal microscopy of the retinaIn a subset of participants over 18 years of age, confocal microscopy of the retina will be performed to assess the presence of diabetic neuropathy | Diagnostic test | Study arm |
Primary outcome
Feasibility of AI for retinopathy screening
Time frame: Through study completion, on average 6 months.
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).
3 secondary outcomes
Examination satisfaction
Time frame: Through study completion, on average 6 months.
Prevalence of diabetic retinopathy
Time frame: Through study completion, on average 6 months.
Prevalence of diabetic neuropathy
Time frame: Through study completion, on average 6 months.
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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-mydriatic fundus camera photography, Fundus ophtalmoscopy and Optic coherence tomography in people with Type 1 Diabetes Mellitus, run by University Hospital, Motol at 1 site in Czechia.
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 3 inclusion and 1 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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 Vit Neuman, MD, PhD (+420 224 432 090, Vit.Neuman@fnmotol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of AI for retinopathy screening (time frame: Through study completion, on average 6 months.). 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 20 Jul 2026.