Diabetic RetinopathyERGDIABNCT06782997
Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
An observational study of Diabetic Retinopathy, run by CHU de Reims at 1 site in France.
Trial summary
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Electroretinogram
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2025to 17 Dec 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with type 1 or type 2 diabetes mellitus and without know DR, followed in both study centers and hospitalized for the evaluation of their diabetes and complications.
Who may be able to join
- Patients > 18 years old
- With type 1 or type 2 diabetes mellitus
- No known diabetic retinopathy
- Affiliated to a social security system
- Attending the hospitals of Reims or Charleville Mézières in France during a hospitalization for the evaluation of their diabetes and complications
Who cannot join
- Known diabetic retinopathy
- Ongoing pregnancy or within 3 months postpartum
- Recent cataract surgery (< 3 months)
- Photosensitive epilepsy
- Patients under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Jenny FONTAINE, 03 26 78 80 21 ext. 0033, jfontaine@chu-reims.fr
About this study
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. In France, in 2020, it was estimated that one-third of diabetic patients had not seen an ophthalmologist in over two years. Recently, a portable electroretinogram (ERG), which provides a physiological and non-invasive assessment of retinal cell function, has been developed. It combines pupillary responses through an infrared-sensitive camera, the implicit time and the response amplitude to brief white light stimuli. The result is expressed as an overall score (DR score), considered abnormal if it is < 7 or > 23.4. The sensitivity of the ERG for screening diabetic retinopathy is estimated at 80%, and its specificity at 82%, compared to conventional imaging. Additionally, it has been shown that poor glycemic control is associated with an increase in implicit time in preclinical DR. This test could therefore detect earlier changes than imaging results. To date, it is not considered the gold standard in France. The investigators aim to test this hypothesis. The investigators propose a prospective, bi-center study to evaluate the performance of the ERG, performed and interpreted by an Advanced Practice Nurse (APN), compared to the gold standard of retinal imaging (retinography) interpreted remotely by an ophthalmologist.
Read the detailed description
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. In France, in 2020, it was estimated that one-third of diabetic patients had not seen an ophthalmologist in over two years. Recently, a portable electroretinogram (ERG), which provides a physiological and non-invasive assessment of retinal cell function, has been developed. It combines pupillary responses through an infrared-sensitive camera, the implicit time and the response amplitude to brief white light stimuli. The result is expressed as an overall score (DR score), considered abnormal if it is < 7 or > 23.4. The sensitivity of the ERG for screening diabetic retinopathy is estimated at 80%, and its specificity at 82%, compared to conventional imaging. Additionally, it has been shown that poor glycemic control is associated with an increase in implicit time in preclinical DR. This test could therefore detect earlier changes than imaging results. To date, it is not considered the gold standard in France. The investigators aim to test this hypothesis. The investigators propose a prospective, bi-center study to evaluate the performance of the ERG, performed and interpreted by an Advanced Practice Nurse (APN), compared to the gold standard of retinal imaging (retinography) interpreted remotely by an ophthalmologist.
The investigators' study will prospectively include adult patients with type 1 or type 2 diabetes mellitus and without know DR. These patients are followed in both study centers and both examinations (ERG and retinography) will be performed during the hospitalization for the evaluation of their diabetes and complications. Sensitivity and specificity of the ERG performed and interpreted by an APN will be compared to gold standard.
- Conditions
- Diabetic Retinopathy
- Being tested
- Electroretinogram
- Keywords
- Diabetes mellitus, electroretinography, screening, diabetic retinopathy, advanced practice nurse
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroretinogramDevice
Electroretinogram (RETevalTM devices, LKC Technologies) performed and interpreted by an advanced practice nurse compared to the gold standard (retinography) interpreted by an ophthalmologist
| Study group | Role | What they receive |
|---|---|---|
| diabetic Patients | Any diabetic hospital patient requiring screening for diabetic retinopathy Receives: Device: Electroretinogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the electroretinogram
Sensitivity of the electroretinogram, performed and interpreted by an advanced practice nurse, for screening diabetic retinopathy compared with the gold standard (retinography interpreted by an ophthalmologist).
Measured: during the patient's hospitalization, an average of 1 week
Secondary outcomes (1)
Specificity, positive predictive value and negative predictive value of the ERG
Specificity, positive predictive value and negative predictive value of the ERG performed and interpreted by an advanced practice nurse, for screening diabetic retinopathy compared with the gold standard
Measured: during the patient's hospitalization, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start17 Jun 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782997
- Sponsor's protocol ID
- PR25001
- Acronym
- ERGDIAB
- Status last verified
- Jul 2025
- First submitted
- 7 Jan 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
- ClinicalTrials.gov ID
- NCT06782997
- Acronym / sponsor ID
- ERGDIAB / PR25001
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes mellitus, electroretinography, screening, diabetic retinopathy, advanced practice nurse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 20 Jan 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.
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. In France, in 2020, it was estimated that one-third of diabetic patients had not seen an ophthalmologist in over two years. Recently, a portable electroretinogram (ERG), which provides a physiological and non-invasive assessment of retinal cell function, has been developed. It combines pupillary responses through an infrared-sensitive camera, the implicit time and the response amplitude to brief white light stimuli. The result is expressed as an overall score (DR score), considered abnormal if it is < 7 or > 23.4. The sensitivity of the ERG for screening diabetic retinopathy is estimated at 80%, and its specificity at 82%, compared to conventional imaging. Additionally, it has been shown that poor glycemic control is associated with an increase in implicit time in preclinical DR. This test could therefore detect earlier changes than imaging results. To date, it is not considered the gold standard in France. The investigators aim to test this hypothesis. The investigators propose a prospective, bi-center study to evaluate the performance of the ERG, performed and interpreted by an Advanced Practice Nurse (APN), compared to the gold standard of retinal imaging (retinography) interpreted remotely by an ophthalmologist.
Detailed description
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. In France, in 2020, it was estimated that one-third of diabetic patients had not seen an ophthalmologist in over two years. Recently, a portable electroretinogram (ERG), which provides a physiological and non-invasive assessment of retinal cell function, has been developed. It combines pupillary responses through an infrared-sensitive camera, the implicit time and the response amplitude to brief white light stimuli. The result is expressed as an overall score (DR score), considered abnormal if it is < 7 or > 23.4. The sensitivity of the ERG for screening diabetic retinopathy is estimated at 80%, and its specificity at 82%, compared to conventional imaging. Additionally, it has been shown that poor glycemic control is associated with an increase in implicit time in preclinical DR. This test could therefore detect earlier changes than imaging results. To date, it is not considered the gold standard in France. The investigators aim to test this hypothesis. The investigators propose a prospective, bi-center study to evaluate the performance of the ERG, performed and interpreted by an Advanced Practice Nurse (APN), compared to the gold standard of retinal imaging (retinography) interpreted remotely by an ophthalmologist.
The investigators' study will prospectively include adult patients with type 1 or type 2 diabetes mellitus and without know DR. These patients are followed in both study centers and both examinations (ERG and retinography) will be performed during the hospitalization for the evaluation of their diabetes and complications. Sensitivity and specificity of the ERG performed and interpreted by an APN will be compared to gold standard.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic Patients | – | Device: ElectroretinogramAny diabetic hospital patient requiring screening for diabetic retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with type 1 or type 2 diabetes mellitus and without know DR, followed in both study centers and hospitalized for the evaluation of their diabetes and complications.
Key inclusion criteria (5 listed)
- Patients > 18 years old
- With type 1 or type 2 diabetes mellitus
- No known diabetic retinopathy
- Affiliated to a social security system
- Attending the hospitals of Reims or Charleville Mézières in France during a hospitalization for the evaluation of their diabetes and complications
Key exclusion criteria (5 listed)
- Known diabetic retinopathy
- Ongoing pregnancy or within 3 months postpartum
- Recent cataract surgery (< 3 months)
- Photosensitive epilepsy
- Patients under legal protection
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 |
|---|---|---|
| ElectroretinogramElectroretinogram (RETevalTM devices, LKC Technologies) performed and interpreted by an advanced practice nurse compared to the gold standard (retinography) interpreted by an ophthalmologist | Device | diabetic Patients |
Primary outcome
Sensitivity of the electroretinogram
Time frame: during the patient's hospitalization, an average of 1 week
Sensitivity of the electroretinogram, performed and interpreted by an advanced practice nurse, for screening diabetic retinopathy compared with the gold standard (retinography interpreted by an ophthalmologist).
1 secondary outcome
Specificity, positive predictive value and negative predictive value of the ERG
Time frame: during the patient's hospitalization, an average of 1 week
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 28 Jul 2025.
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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?
An observational study of Diabetic Retinopathy, run by CHU de Reims at 1 site in France.
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 5 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 28 Jul 2025. 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 France. 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 Jenny FONTAINE (03 26 78 80 21 ext. 0033, jfontaine@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the electroretinogram (time frame: during the patient's hospitalization, an average of 1 week). 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 28 Jul 2025.