Feasibility of Home Monitoring of Visual Function in DR

Queen's University Belfast

Status: Completed

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

Treatments: Device: Okko Health App

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07386613

307008

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria: Study 1 and 2:

• 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).

Trial design

55 participants in 1 patient group

Patients with diabetes at high risk of retinopathy

Treatment:

Device: Okko Health App