Diabetes MellitusSCADENCT03587948
Shanghai Children and Adolescent Diabetes Eye Study
An observational study of Diabetes Mellitus and Eye Diseases, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
To compare the prevalence of eye disease between children and adolescents with diabetes mellitus and healthy people, and to analyze the related factors of eye diseases in diabetic patients. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Eye Diseases
- What is being tested?
- Diabetes mellitus
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2028
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: From January 2018 to 2028, children who are diagnosed with diabetes at the Children's Hospital of Fudan University in Shanghai, will be recruited as cases of diabetes. We will also recruit children without diabetes, who will be matched for age and gender, from this hospital as controls.
Who may be able to join
- (1) provision of a written informed consent by a guardian;
- (2) age over 5 years and less than 18 years;
- (3) diagnosis of type 1 or type 2 diabetes based on the WHO diagnostic criteria for cases.
Who cannot join
- (1) eyelid diseases - eyelid entropion, eyelid ectropion, eyelid, ptosis, and palpebral dyskinesia;
- (2) conjunctival diseases - pterygium and conjunctivitis;
- (3) history of ocular surface chemical injury or use of eye drops with moisturizing artificial tears;
- (4) history of eye surgery within 6 months or history of retinal laser photocoagulation;
- (5) systemic diseases - Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave 's disease, systemic lupus erythematosus, and others.
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
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Haidong Zou, Ph.D, 8613311986528, zouhaidong@263.net
About this study
To compare the prevalence of eye disease between children and adolescents with diabetes mellitus and healthy people, and to analyze the related factors of eye diseases in diabetic patients.
Read the detailed description
A cohort study. From January 2018 to 2028, 300 cases of diabetic children in Children's Hospital of Fudan University in Shanghai will be selected as case group, and 300 healthy children without diabetes will be selected as the control group.
The purpose of the study is to guide and regulate eye health screening of children and adolescents with diabetes in Children's Hospital of Fudan University in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance, thus upgrading the level of eye disease prevention and treatment in Shanghai.
- Conditions
- Diabetes Mellitus, Eye Diseases
- Being tested
- Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes mellitusDiagnostic test
Children and adolescents who is diagnosed with diabetes will be involved in case-group, and others will be involved in control-group.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Children and adolescents with diabetes mellitus Receives: Diagnostic Test: Diabetes mellitus | |
| Control group | Children and adolescents without diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic eye diseases
Prevalence of eye diseases due to diabetes.
Measured: January 1, 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Haidong Zou, MD,PhD, Study chair, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587948
- Sponsor's protocol ID
- 2018004
- Acronym
- SCADE
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Children and Adolescent Diabetes Eye Study
- ClinicalTrials.gov ID
- NCT03587948
- Acronym / sponsor ID
- SCADE / 2018004
- Conditions
- Diabetes Mellitus, Eye Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Jul 2018 (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.
To compare the prevalence of eye disease between children and adolescents with diabetes mellitus and healthy people, and to analyze the related factors of eye diseases in diabetic patients.
Detailed description
A cohort study. From January 2018 to 2028, 300 cases of diabetic children in Children's Hospital of Fudan University in Shanghai will be selected as case group, and 300 healthy children without diabetes will be selected as the control group.
The purpose of the study is to guide and regulate eye health screening of children and adolescents with diabetes in Children's Hospital of Fudan University in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance, thus upgrading the level of eye disease prevention and treatment in Shanghai.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: Diabetes mellitusChildren and adolescents with diabetes mellitus |
| Control group | – | –Children and adolescents without diabetes mellitus |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- From January 2018 to 2028, children who are diagnosed with diabetes at the Children's Hospital of Fudan University in Shanghai, will be recruited as cases of diabetes. We will also recruit children without diabetes, who will be matched for age and gender, from this hospital as controls.
Key inclusion criteria (3 listed)
- (1) provision of a written informed consent by a guardian;
- (2) age over 5 years and less than 18 years;
- (3) diagnosis of type 1 or type 2 diabetes based on the WHO diagnostic criteria for cases.
Key exclusion criteria (5 listed)
- (1) eyelid diseases - eyelid entropion, eyelid ectropion, eyelid, ptosis, and palpebral dyskinesia;
- (2) conjunctival diseases - pterygium and conjunctivitis;
- (3) history of ocular surface chemical injury or use of eye drops with moisturizing artificial tears;
- (4) history of eye surgery within 6 months or history of retinal laser photocoagulation;
- (5) systemic diseases - Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave 's disease, systemic lupus erythematosus, and others.
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 |
|---|---|---|
| Diabetes mellitusChildren and adolescents who is diagnosed with diabetes will be involved in case-group, and others will be involved in control-group. | Diagnostic test | Case group |
Primary outcome
Diabetic eye diseases
Time frame: January 1, 2028
Prevalence of eye diseases due to diabetes.
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 16 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Haidong Zou, MD,PhD study chair
Shanghai Eye Disease Prevention and Treatment Center
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 Diabetes Mellitus and Eye Diseases, run by Shanghai Eye Disease Prevention and Treatment Center 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 3 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 16 Jul 2018. 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 Haidong Zou, post-doctor (13311986528, zouhaidong@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic eye diseases (time frame: January 1, 2028). 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 16 Jul 2018.