An observational study in Diabetes (DM), Diabetes Complication and Diabetes (Insulin-requiring, Type 1 or Type 2), sponsored by Queen's University, Belfast. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Queen's University, Belfast · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 55 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.
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Participants with type 1 or type 2 diabetes with either no diabetic retinopathy (R0) or early background changes (R1)
Inclusion Criteria:
Study 1:
Study 2:
Exclusion Criteria: Study 1 and 2:
Device: Okko Health App
Okko Health digital health app used to assess visual acuity and contrast sensitivity using a mobile phone.
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.
Time frame: 6 months
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'.
Time frame: 6 months
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.
Given the study's exploratory nature and the lack of suitably developed instruments, open-ended survey questions were added to the adapted EUAQ (Tay et al. 2004). These were administered to capture patients' experiences and potential challenges using the OKKO Health app. They began with the question, 'Did you find the tests easy to do? If no- How?'. This question was followed by a list of seven items such as: 'Did you find any of the tests particularly difficult?'; 'Which was your favourite test? Why?'; 'If you knew you had to continue to carry out these tests for a longer period of time would you be willing to continue?'. A multi-line text entry field was implemented in Qualtrics, which allowed participants responses up to five lines. An analysis of the answers to these questions aided the exploration of challenges to. Implementation. In addition to the open-ended questionnaire responses, supplementary qualitative feedback was recorded using multiple sources, through entries in the r
Time frame: 6 months
Plan to share: 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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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Queen's University, Belfast