Diabetes (DM)NCT07386613
Feasibility of Home Monitoring of Visual Function in DR
An observational study of Diabetes (DM) and Diabetes Complication, run by Queen's University, Belfast at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes (DM), Diabetes Complication, Diabetes (Insulin-requiring, Type 1 or Type 2)
- What is being tested?
- Okko Health App
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 Sep 2023to 20 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with type 1 or type 2 diabetes with either no diabetic retinopathy (R0) or early background changes (R1)
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Northern Health and Social Care Trust, Antrim Hospital
Antrim, County Antrim, BT412RL
Belfast Health and Social Care Trust, Belfast City Hospital
Belfast, Belfast City, BT97AB
Southern Health and Social Care Trust, Craigavon Hospital
Craigavon, County Armagh, BT63 5QQ
About this study
Official title: Investigating the Feasibility of Home Monitoring of Visual Function in Populations at High Risk of Developing Diabetic Retinopathy (DR) Using Novel Game-based Technology (OKKO Health)
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, Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetic Retinopathy (DR), Diabetes Pregnancy, Gestational Diabetes Mellitus in Pregnancy
- Being tested
- Okko Health App
- Keywords
- Remote monitoring, Digital Health, Visual function, High risk patients, Diabetic retinopathy
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications, Diabetic Retinopathy, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Okko Health AppDevice
Okko Health digital health app used to assess visual acuity and contrast sensitivity using a mobile phone.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes at high risk of retinopathy | Not described Receives: Device: Okko Health App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
This study utilized both quantitative and qualitative data to assess acceptability and adherence including The Adherence and Acceptability Questionnaire (AAQ) (adapted from Venkatesh et al., 2003) and The Ease of Use and Acceptability Questionnaire (EUAQ) (modified from Tay et al., 2004).
The adapted 16-item AAQ asked participants questions about their experience regarding five dimensions or aspects of the app: perceived usefulness, perceived ease of use, adherence, behavioural intention and digital system accessibility. For example, the AAQ questionnaire began with the following statement: "I think that using digital health interventions to monitor my vision weekly could be a good thing". Participants then rated this statement in relation to their experience of using the OKKO Health app on a five-point Likert scale, ranging from 1: 'Strongly Disagree' to '5: 'Strongly Agree'.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start9 Sep 2023
- Primary completion20 Jun 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- OKKO Health
- Responsible party
- Principal investigator, Ruth Hogg, Queen's University, Belfast
- Investigators
- Professor Ruth E Hogg, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386613
- Sponsor's protocol ID
- 307008
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make the individual participant data available as the research is currently being submitted as part of a PhD thesis. The full thesis will be available via open access on the Queen's University Belfast repository.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of Home Monitoring of Visual Function in Populations at High Risk of Developing Diabetic Retinopathy (DR) Using Novel Game-based Technology (OKKO Health)
- ClinicalTrials.gov ID
- NCT07386613
- Acronym / sponsor ID
- 307008
- Conditions
- Diabetes (DM), Diabetes Complication, Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetic Retinopathy (DR), Diabetes Pregnancy, Gestational Diabetes Mellitus in Pregnancy
- Keywords
- Remote monitoring, Digital Health, Visual function, High risk patients, Diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- OKKO Health
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes at high risk of retinopathy | – | Device: Okko Health App |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with type 1 or type 2 diabetes with either no diabetic retinopathy (R0) or early background changes (R1)
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Okko Health AppOkko Health digital health app used to assess visual acuity and contrast sensitivity using a mobile phone. | Device | Patients with diabetes at high risk of retinopathy |
Primary outcome
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.
Time frame: 6 months
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.
1 secondary outcome
Secondary Outcome: Explore the acceptability of longitudinal monitoring in populations at risk of DR that are hard to reach through qualitative and interview data.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. There is not a plan to make the individual participant data available as the research is currently being submitted as part of a PhD thesis. The full thesis will be available via open access on the Queen's University Belfast repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Ruth E Hogg, PhD principal investigator
Queen's University, Belfast
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM) and Diabetes Complication, run by Queen's University, Belfast at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.