DiabetesNCT06819423
The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
A study testing AI fundus photography in people with Diabetes, run by Jie Li at 1 site in China.
Trial summary
This study aims to evaluate the impact of AI-based fundus imaging on blood glucose control and fundus examination completion rates in diabetic patients by comparing outcomes between those who undergo AI fundus imaging and those who do not. The study is designed as a parallel randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- AI fundus photography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 26 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of Type 2 Diabetes Mellitus.
- Patients with a glycated hemoglobin (HbA1c) level > 7%.
- Ability to comply with all required examinations and provide signed informed consent.
Who cannot join
- No previous diabetic fundus examination.
- No known diabetic retinopathy.
- Absence of other ocular diseases that could lead to retinopathy.
- Subjects from whom clear fundus photographs could not be obtained.
- Patients with comorbid malignant tumors or severe cardiovascular diseases.
- Patients anticipated to have difficulties with follow-up or those residing in other provinces.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610014
Jie Li, doctor, +86 13908094675, lijieyk@med.uestc.edu.cn
About this study
This study aims to evaluate the impact of AI-based fundus imaging on blood glucose control and fundus examination completion rates in diabetic patients by comparing outcomes between those who undergo AI fundus imaging and those who do not. The study is designed as a parallel randomized controlled trial (RCT).
Using a random number table, 200 diabetic patients visiting the Department of Endocrinology at Sichuan Provincial People's Hospital between December 2024 and December 2025 will be equally divided into two groups: an intervention group and a control group. Each group will consist of 100 patients, assigned unique random numbers. The intervention group will undergo AI-based fundus imaging once, with the imaging process taking approximately 5 minutes. The control group will receive standard eye health education without AI fundus imaging.
The primary outcomes, including blood glucose control, systemic indicators, and fundus examination completion rates, will be assessed and compared between the two groups at 3-month and 6-month follow-ups. This study seeks to determine the value of AI-based fundus imaging in improving diabetes management and complication prevention in diabetic patients.
- Conditions
- Diabetes
- Being tested
- AI fundus photography
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI fundus photographyDevice
In the dark room, Canon CR-2AF automatic mydria-free fundus camera was used to collect images of both eyes of the patients, and one fundus photo was taken with macula as the center of each eye
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes who received health education and AI fundus photography in our hospital | Experimental | Not described Receives: Device: AI fundus photography |
| Patients with diabetes who received health education in our hospital | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose level
Blood Glucose Control Status in Two Groups of Patients
Measured: From enrollment to reexamination at 3 months and 6 months
Blood Glucose Control Status in Two Groups of Patients after 3 Months and 6 Months
glycated hemoglobin (HbA1c) level
Measured: From enrollment to reexamination at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start26 Dec 2024
- Primary completion26 Dec 2025 (estimated)
- Study completion26 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819423
- Sponsor's protocol ID
- 2024-KY652-1
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2030, via https://pan.baidu.com
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients
- ClinicalTrials.gov ID
- NCT06819423
- Acronym / sponsor ID
- 2024-KY652-1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jie LiUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 26 Dec 2025 (estimated)
- Study completion
- 26 Dec 2025 (estimated)
- First posted
- 11 Feb 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.
This study aims to evaluate the impact of AI-based fundus imaging on blood glucose control and fundus examination completion rates in diabetic patients by comparing outcomes between those who undergo AI fundus imaging and those who do not. The study is designed as a parallel randomized controlled trial (RCT).
Using a random number table, 200 diabetic patients visiting the Department of Endocrinology at Sichuan Provincial People's Hospital between December 2024 and December 2025 will be equally divided into two groups: an intervention group and a control group. Each group will consist of 100 patients, assigned unique random numbers. The intervention group will undergo AI-based fundus imaging once, with the imaging process taking approximately 5 minutes. The control group will receive standard eye health education without AI fundus imaging.
The primary outcomes, including blood glucose control, systemic indicators, and fundus examination completion rates, will be assessed and compared between the two groups at 3-month and 6-month follow-ups. This study seeks to determine the value of AI-based fundus imaging in improving diabetes management and complication prevention in diabetic patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes who received health education and AI fundus photography in our hospital | Experimental | Device: AI fundus photography |
| Patients with diabetes who received health education in our hospital | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Diagnosis of Type 2 Diabetes Mellitus.
- Patients with a glycated hemoglobin (HbA1c) level > 7%.
- Ability to comply with all required examinations and provide signed informed consent.
Key exclusion criteria (6 listed)
- No previous diabetic fundus examination.
- No known diabetic retinopathy.
- Absence of other ocular diseases that could lead to retinopathy.
- Subjects from whom clear fundus photographs could not be obtained.
- Patients with comorbid malignant tumors or severe cardiovascular diseases.
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 |
|---|---|---|
| AI fundus photographyIn the dark room, Canon CR-2AF automatic mydria-free fundus camera was used to collect images of both eyes of the patients, and one fundus photo was taken with macula as the center of each eye | Device | Patients with diabetes who received health education and AI fundus photography in our hospital |
Primary outcome
fasting blood glucose level
Time frame: From enrollment to reexamination at 3 months and 6 months
Blood Glucose Control Status in Two Groups of Patients
Blood Glucose Control Status in Two Groups of Patients after 3 Months and 6 Months
Time frame: From enrollment to reexamination at 3 months and 6 months
glycated hemoglobin (HbA1c) level
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 11 Feb 2025.
- Individual participant dataSharing planned: Yes. 2030, via https://pan.baidu.com
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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 AI fundus photography in people with Diabetes, run by Jie Li at 1 site in China.
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 4 inclusion and 6 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 11 Feb 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 China. 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 Jie Li, doctor (+86 139 0809 4675, lijieyk@med.uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glucose level (time frame: From enrollment to reexamination at 3 months and 6 months). The study lists 2 primary outcomes in all. 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 11 Feb 2025.