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Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study (SMART)

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ClinicalTrials.gov Identifier: NCT03572699
Recruitment Status : Unknown
Verified October 2018 by Dr Srikanth Y N, Medios Technologies Pte. Ltd.
Recruitment status was:  Recruiting
First Posted : June 28, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Diacon Hospital
Information provided by (Responsible Party):
Dr Srikanth Y N, Medios Technologies Pte. Ltd

Tracking Information
First Submitted Date June 16, 2018
First Posted Date June 28, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date July 11, 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2018)
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2018)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
Official Title Simple, Mobile-based Artificial Intelligence AlgoRithms in the Detection of Diabetic ReTinopathy (SMART) Study
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with diabetes mellitus presenting to the outpatient for routine clinical care.
Condition Diabetic Retinopathy
Intervention Other: diabetic retinopathy
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 27, 2018)
900
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with type 1 or type 2 diabetes mellitus
  2. Ages 18 and above
  3. Male and female

Exclusion Criteria:

  1. Persistent visual impairment in one or both eyes;
  2. Subjects with corneal opacities and advanced cataract.
  3. History of retinal vascular (vein or artery) occlusion;
  4. Subject is contraindicated for fundus photography (for example, has light sensitivity);
  5. Subject is currently enrolled in an interventional study of an investigational device or drug;
  6. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03572699
Other Study ID Numbers SMART1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr Srikanth Y N, Medios Technologies Pte. Ltd
Study Sponsor Medios Technologies Pte. Ltd
Collaborators Diacon Hospital
Investigators
Principal Investigator: Srikanth Y N, MS Investigator
PRS Account Medios Technologies Pte. Ltd
Verification Date October 2018