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

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 Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Other: diabetic retinopathy

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Srikanth Y N, MS; Phone Number: 9886450550; Email: srikanthyn@yahoo.com
• Study Contact Backup: Name: Bhavana Sosale, MD; Phone Number: 9449478512; Email: bhavanasosale@gmail.com

Study Locations

• India
  • Bangalore, India, 560010
    • Recruiting
    • Diacon Hospital
    • Contact: Bhavana Sosale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals with diabetes mellitus presenting to the outpatient for routine clinical care.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of the AI in detecting any grade of diabetic retinopathy	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of the AI in detecting referable diabetic retinopathy (referable retinopathy defined as moderate non proliferative retinopathy or greater)	3 months
Sensitivity and specificity of the AI in detecting sight threatening diabetic retinopathy (referable retinopathy defined as severe non proliferative retinopathy or greater)	3 months

Collaborators and Investigators

• Sponsor: Medios Technologies Pte. Ltd
• Collaborators: Diacon Hospital
• Investigators: Principal Investigator: Srikanth Y N, MS, Investigator

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2018
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: June 16, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (ACTUAL): June 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: SMART1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No