Feasibility of Home Monitoring of Visual Function in DR

NCT07386613 | Completed

• 1 other identifier: 307008
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

Diabetes is a serious condition where patients can develop complications in their body including their eyes which can lead to sight loss. Patients with diabetes are encouraged to attend yearly screening appointments at which signs of Diabetic Retinopathy (DR) are assessed. Attendance at these appointments and at any follow-up appointments can be time-consuming and inconvenient for those working. Better ways to monitor changes in vision are needed. Therefore, we are hoping to develop a set of eye tests that a person with diabetes can complete at home on a smartphone in collaboration with researchers at OKKO Health.

Conditions

Diabetes (DM); Diabetes Complication; Diabetic Retinopathy (DR); Diabetes Pregnancy; Gestational Diabetes Mellitus in Pregnancy; Dialysis Patients; Diabetes (Insulin-requiring, Type 1 or Type 2)

Keywords

Remote monitoring; Digital Health; Visual function; High risk patients; Diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome : Explore the feasibility of longitudinal monitoring in hard-to-reach clinical populations by analysing recruitment and retention data, frequency of testing, and factors influencing play frequency and sustained engagement with the app.

  Assessment of feasibility Feasibility was assessed using recruitment, retention and engagement data from the Dialysis, Pregnancy and CGM high risk groups. Attrition rates from verbal agreement to signed consent and study completion were documented and reasons for dropout were captured through research team notes, participant self-report and follow-up communication. Engagement was quantified as the number of OKKO Health app plays over 6 months for each eye in the OKKO Circles Acuity (LogMAR) and the OKKO Contrast Sensitivity (LogCS) games. Participants were requested to play both games at least once a week. The app automatically logged usage data, including total plays and plays per eye.

  6 months

Secondary Outcomes (1)

• Secondary Outcome: Explore the acceptability of longitudinal monitoring in populations at risk of DR that are hard to reach through qualitative and interview data.

  6 months

Other Outcomes (1)

• 3. Third Outcome Measure: Describe the challenges associated with implementing longitudinal home-based monitoring in high-risk populations, identifying key logistical, behavioural, and technological barriers to engagement.

  6 months

Study Arms (1)

Patients with diabetes at high risk of retinopathy

Device: Okko Health App

Interventions

Okko Health App DEVICE

Okko Health digital health app used to assess visual acuity and contrast sensitivity using a mobile phone.

Patients with diabetes at high risk of retinopathy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with type 1 or type 2 diabetes with either no diabetic retinopathy (R0) or early background changes (R1)

You may qualify if:

• Study 1:
• The 55 participants with Type 1 or Type 2 diabetes must also be a gestational, or dialysis DR patient.
• Aged 18-70.
• All participants should have access to one of the following devices on a daily basis: iPhone (X, XS, XR, 11, 11 Pro, 11 Pro Max, SE 2020, 12, 12 Pro, 12 Pro Max, 12 mini); iPad (Pro 11-inch 2nd generation, Pro 12.9-inch 4th generation); Samsung Galaxy S8, S9, S10, A20e or A40; Samsung Galaxy Tab S3; Honor 10 Lite; Motorola G6 or G7 Power or Pixel 3a.
• All participants should also have the ability to read and understand in English and be able to give informed consent.
• All participants should also be able to tap the screen of a digital device.
• All gestational and dialysis participants should be willing to undergo handheld retinal imaging, no pupil dilation is required.
• Be willing to use the app from home for up to 6 months in between the participant's regular clinic visits.
• Study 2:
• The 35 participants with type 1 or type 2 diabetes should have R0 no retinopathy or R1 background changes (this is stated on the letter they receive from the Diabetic Retinal Screening service).
• Participants must already have a diabetic screening letter dated within 3 months and use a continuous glucose monitor and be willing to share the data from their monitor with the study team. They must also be willing to allow the research team access to their most recent OCT scans which will be accessed by Prof Tunde Peto.
• All participants should have access to one of the following devices on a daily basis: iPhone (X, XS, XR, 11, 11 Pro, 11 Pro Max, SE 2020, 12, 12 Pro, 12 Pro Max, 12 mini); iPad (Pro 11-inch 2nd generation, Pro 12.9-inch 4th generation); Samsung Galaxy S8, S9, S10, A20e or A40; Samsung Galaxy Tab S3; Honor 10 Lite; Motorola G6 or G7 Power or Pixel 3a.
• All participants should also have the ability to read and understand in English and be able to give informed consent.
• All participants should also be able to tap the screen of a digital device

You may not qualify if:

• The presence of another ocular disease that impacts vision such as age-related macular degeneration, glaucoma, or active uveitis.
• Participants who are unable to tap a screen.
• Serious life-threatening conditions that would preclude attendance in the longitudinal part of the study.
• Neurological conditions that can impair vision
• Any physical limitation that would make the participant unable to attend clinic visits (e.g., patients with arthritis or neck problems who may be unable to sit for a prolonged period of time).

Sponsors & Collaborators

• Queen's University, Belfast: lead
• OKKO Health: collaborator

Study Sites (3)

Belfast Health and Social Care Trust, Belfast City Hospital

Belfast, Belfast City, BT97AB, United Kingdom

Location

Northern Health and Social Care Trust, Antrim Hospital

Antrim, County Antrim, BT412RL, United Kingdom

Location

Southern Health and Social Care Trust, Craigavon Hospital

Craigavon, County Armagh, BT63 5QQ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Diabetic Retinopathy; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Professor Ruth E Hogg, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ruth Esther Hogg

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 4, 2026
• Study Start: September 9, 2023
• Primary Completion: June 20, 2024
• Study Completion: July 20, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)