Supporting people with type 2 diabetes in effective use of their medicine through a system comprising mobile health technology integrated with clinical care compared with usual care: a randomised controlled trial.

Bangor University and the University of Oxford require access to NHS England data for the purpose of the following research project:

Supporting people with type 2 diabetes in effective use of their medicine through a system comprising mobile health technology integrated with clinical care compared with usual care: randomised controlled trial (SuMMiT-D)

The following is a summary of the aims of the research project provided by Bangor University and the University of Oxford:

Type 2 diabetes is a common disease affecting over 400 million people worldwide. Risk of serious complications can be reduced through use of effective treatments and active self-management. However, people are often concerned about starting new medicines and face difficulties in taking them regularly. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. The University of Oxford and the University of Manchester have developed and tested messages aiming to support patients’ self-management of type 2 diabetes in the use of medications and other aspects of self-management, underpinned by theory and evidence.

The aim of this trial is to compare the effectiveness and cost-effectiveness of brief messaging to support patients with type 2 diabetes taking diabetes medicine (glucose, blood pressure, or lipid lowering) in reducing risk factors for diabetes complications, with usual care. The economic analysis is required as it cannot be assumed that an effective intervention will save costs or offer value for money for the NHS.

To fulfil the objective of the SuMMiT-D study relative to cost-effectiveness, Bangor University will conduct a health economic analysis that will adopt the perspective of the National Health Service (NHS) and Personal Social Services (PSS). By measuring resource use, researchers will estimate the overall cost for each patient. The NHS England data will be analysed using standard statistical and health economic methods, and an existing health economics model will be used to estimate costs and benefits over a lifetime.

Online patient questionnaires have also been administered but are reliant on patient completion as well as patient recall and may introduce biases into the cost-effectiveness analysis results. Questionnaire data will be used to supplement HES data for participants where HES data are unavailable. This information can then be used to inform future support for NHS patients with the condition by indicating which arm offers the best value for money.

Once data processing is complete, the Data will be archived to allow any questions or challenges on the published results to be addressed, which may lead to a need to repeat the previously analyses undertaken to verify that the published results were accurate.

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC), Emergency Care Data Set (ECDS), HES Critical Care (CC) and HES Outpatients (OP). These datasets are required to obtain robust, reliable data on hospital visits and to cost the two intervention arms compared in the study, which comprises an evaluation of the resources used by patients in the SuMMiT-D trial. Some demographic data are requested as they are required for processing using the NHS England Costing Grouper.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by the University of Oxford – SuMMiT-D opened for recruitment in March 2021 and reached its recruitment target by July 2021 with a total of 1039 participants. Participants were followed over a period of 52 weeks. Data is restricted to patients who have consented to participate in the SuMMiT-D trial and have agreed for their personal data to be shared with NHS England.

> Limited to data between 2020/21 and 2022/23. For each individual patient, data will only be provided from 3-months prior to their entry in the study and spanning the duration of 12—months after their recruitment, including any episodes that run during this period. Data prior to entry into the study is required to establish a participants baseline costs. Episode start date is required in order to separate episodes in the baseline period from those during the trial period.

> Fields requested are minimised to those required by the NHS England Costing Grouper.

The University of Oxford is the research sponsor. Together, with Bangor University, the organisations are jointly responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it is expected to inform the NHS, clinical commissioners and other healthcare decision makers on the most clinical and cost-effective intervention for this condition.

The funding is provided by National Institute for Health Research (NIHR). The funding is specifically for the study described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

The University of Manchester was involved in the overall programme design, and collaborators in the University of Manchester were involved in the following activities: creating the text message library, formative work on the text messages, and, during the feasibility and main trials, recruitment of participating GP practices, participant recruitment, qualitative interviews with participants, and qualitative analysis of participant completed questionnaires. A co-investigator for the study based at the University of Manchester assisted in the recruitment phase only. The University of Manchester will not have access to or any influence on how or why the NHS England data will be processed.

A Patient and Public Involvement (PPI) group was established at the start of the programme. The group were involved in reviewing the trial materials (Patient information leaflets, consent forms and posters) prior to submission to the research ethics committee. Throughout the programme, the University of Oxford have continued to hold regular meetings with the PPI group at key stages of the programme to update and gain feedback on patient facing documentation, and plans for dissemination of results when available. The PPI group is also represented on the programme steering committee.

The University of Oxford will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Names and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES and ECDS datasets to Bangor University. The Data will

> contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be stored on servers at Bangor University.

The Data will be accessed onsite at the premises of Bangor University only.

The Data will not leave Wales at any time.

Access is restricted to employees or agents of Bangor University who have authorisation from the Principal Investigator. All such individuals are substantive employees of Bangor University.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

Patients will be linked to their arm of the study via their unique person ID. Bangor University researchers will not have access to the unique person ID key that allows patient identification.

Bangor University will derive Healthcare Resource Groups (HRG) codes from the HES data using the NHS England Costing Grouper and will apply HRG costs from publicly available National Tariff registers.

The cost data will then be extracted to the health economics analysis file and linked with study data including self-reported resource use and outcomes obtained from patient questionnaires and primary care and prescribing resource use data obtained via Egton Medical Information Systems (EMIS). The health economics analysis file will be held on secure servers at Bangor University.

The Data will not be linked with any other data.

Researchers from Bangor University will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> Public reports (one-off submission expected at the end of data processing)

> Contributions to the NIHR PGfAR report underpinning the SuMMiT-D study, which will be a wider report on the entire SuMMiT-D study published on the NIHR website. One of the sections of this report will be dedicated to health economics.

> Submission to a peer reviewed journal, such as the New England Journal of Medicine.

> Presentations at appropriate local, national and international conferences and symposium

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Presentations at appropriate local, national and international conferences and symposium

> Public reports

> The wider report on the entire SuMMiT-D study will be published on the NIHR website

Outputs are expected to be produced within 18 months of the receipt of data from NHS England.

Type 2 diabetes can cause serious long-term health problems. It is one of the most common long-term conditions affecting 422 million people worldwide and 4.7 million people in the UK. In addition to the prevalence of preventable death and disability associated with type 2 diabetes, the cost of non-adherence with diabetes treatments has been estimated at £100 million a year in avoidable treatment costs. Understanding and improving this situation could make a major contribution to reducing health and NHS costs. Brief messages delivered at a wide-scale and low cost via digital health systems added to usual care have been shown to be effective in improving health for some conditions and are a promising approach to the problem.

Analysis based on the data received from NHS England will contribute to the NHS and wider clinical research communities’ (including decision-makers in local government, policymakers including NICE, researchers, NHS health professionals, other NIHR stakeholders, and the general public) understanding of the most clinically and cost-effective means of supporting patients with type 2 diabetes taking medicine, using brief messaging. It would not be possible to undertake a robust economic evaluation without the NHS England HES data.

If effective, this intervention could reduce the burden of complications and increased costs associated with under-use of diabetes medicines. A coordinated system for automated reminders could improve satisfaction with health services and offer a model for technology-based self-management support. This could be extended to other aspects of diabetes care, and other long-term conditions.

As a result of this analysis health care professionals and NHS commissioners will be better informed about the potential for support via brief messaging to be clinically and cost-effective i.e., whether support via brief text messages offers value for money to the NHS healthcare system. This health care benefit is expected to not only affect the NHS in terms of efficacy and best use of resources, but also the patients in terms of clinical outcomes and the global healthcare research community.

The use of the data could:

> inform decisions on how to effectively allocate and evaluate funding according to health needs.

> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

> support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The dissemination activities undertaken concerning the SuMMiT-D study are two-fold; to enable the engagement with the scientific and policy-making communities and to ensure that knowledge developed by the research can benefit these communities.

The collaborative SuMMiT-D programme grant team will participate in active communication activities to ensure any information about the project and its results reach interested groups and civil society and will involve knowledge sharing and dialogue. Planned communication channels to key stakeholders including decision-makers in local government, policymakers including NICE, researchers, NHS health professionals, other NIHR stakeholders, and the general public will be made through the SuMMiT-D website and newsletters. Once the results of the study are published, it will then be up to local decision-makers and the general public to implement the changes.

The data have enabled the economic analysis for the SuMMiT-D Trial. The trial results are anticipated to be published in 2026.