Recruiting

AI System

Sponsor:

Digital Diagnostics, Inc.

Code:

NCT07844317

Conditions

Diabetic Retinopathy (DR)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

SaMD intended for the detection of diabetic retinopathy in adults with diabetes.

An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.

Study Details

Brief summary:

Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.

Conditions

Diabetic Retinopathy (DR)

Study ID

NCT07844317

Start date

Aug 24, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 22 years of age or older
  • Diagnosis of DM
  • Ability to understand and willing to sign a written ICF

Exclusion Criteria:

Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Single arm, non-randomized cohort

Adult, 22 years or older with a diagnosis of diabetes

Interventions

SaMD intended for the detection of diabetic retinopathy in adults with diabetes.

No significant difference to other SaMDs for the detection of DR that are commercialized.

An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.

SaMD to detect diabetic retinopathy

Primary outcome measure

  • Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Audrey Singh Singh

7633702127singh@digitaldiagnostics.com

Locations

Rovia Site Network

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Regional Director of Operations

904-735-5466margot.wrenn@roviaclinical.com

More Information

Sponsor

Digital Diagnostics, Inc.

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • AI-enabled
  • Diabetic Retinopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Digital Diagnostics, Inc. on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.