Diabetic RetinopathySMARTNCT03572699
Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
An observational study of Diabetic Retinopathy, run by Medios Technologies Pte. Ltd at 1 site in India.
Trial summary
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes. 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?
- diabetic retinopathy
- How many people
- 900 participants
- Where
- 1 siteIndia
- Study dates
- 11 Jul 2018to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Individuals with diabetes mellitus presenting to the outpatient for routine clinical care.
Who may be able to join
- Patients with type 1 or type 2 diabetes mellitus
- Ages 18 and above
- Male and female
Who cannot join
- Persistent visual impairment in one or both eyes;
- Subjects with corneal opacities and advanced cataract.
- History of retinal vascular (vein or artery) occlusion;
- Subject is contraindicated for fundus photography (for example, has light sensitivity);
- Subject is currently enrolled in an interventional study of an investigational device or drug;
- Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Diacon Hospital
Bangalore, 560010
Bhavana Sosale
About this study
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.
- Conditions
- Diabetic Retinopathy
- Being tested
- diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetic retinopathyOther
This is an observational study of patients with diabetes. Patients undergoing routine care will undergo retinal imaging using a nonmydriatic fundus camera. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the artificial intelligence algorithm will be compared to the image diagnosis given by the ophthalmologists. The ophthalmologists will be blinded to the diagnosis of the AI and vice versa. The data will be analyzed to evaluate the performance of the AI.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy
Measured: 3 months
Secondary outcomes (2)
Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater)
Measured: 3 months
Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start11 Jul 2018
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medios Technologies Pte. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Diacon Hospital
- Responsible party
- Principal investigator, Dr Srikanth Y N, Medios Technologies Pte. Ltd
- Investigators
- Srikanth Y N, MS, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572699
- Sponsor's protocol ID
- SMART1
- Acronym
- SMART
- Status last verified
- Oct 2018
- First submitted
- 16 Jun 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
- ClinicalTrials.gov ID
- NCT03572699
- Acronym / sponsor ID
- SMART / SMART1
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Medios Technologies Pte. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Diacon Hospital
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 28 Jun 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.
This is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with diabetes mellitus presenting to the outpatient for routine clinical care.
Key inclusion criteria (3 listed)
- Patients with type 1 or type 2 diabetes mellitus
- Ages 18 and above
- Male and female
Key exclusion criteria (6 listed)
- Persistent visual impairment in one or both eyes;
- Subjects with corneal opacities and advanced cataract.
- History of retinal vascular (vein or artery) occlusion;
- Subject is contraindicated for fundus photography (for example, has light sensitivity);
- Subject is currently enrolled in an interventional study of an investigational device or drug;
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 |
|---|---|---|
| diabetic retinopathyThis is an observational study of patients with diabetes. Patients undergoing routine care will undergo retinal imaging using a nonmydriatic fundus camera. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the artificial intelligence algorithm will be compared to the image diagnosis given by the ophthalmologists. The ophthalmologists will be blinded to the diagnosis of the AI and vice versa. The data will be analyzed to evaluate the performance of the AI. | Other | – |
Primary outcome
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy
Time frame: 3 months
2 secondary outcomes
Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater)
Time frame: 3 months
Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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. This study is not recruiting at the moment.
Srikanth Y N, MS principal investigator
Investigator
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 Medios Technologies Pte. Ltd at 1 site in India.
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 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: status not confirmed, as of the sponsor's last update on 9 Oct 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Srikanth Y N, MS (9886450550, srikanthyn@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy (time frame: 3 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 9 Oct 2018.