Continuation of order NIC-147204-CGWY5 MR1283: DARE (Diabetes Alliance for Research in England) - NE London Diabetes Research Network Locality

The Diabetes Alliance for Research in England (DARE) study was established in order to understand the cause of diabetes and its complications such as heart disease, diabetic eye disease and diabetic kidney disease, and to improve treatment and prevention of these important illnesses, the DARE study team need to find both the genes (the inherited code which may be passed down through generations) and also non-inherited factors that make some people more likely to get diabetes and the medical problems related to diabetes. This research study is a nationwide collaboration between patients and professionals to provide a platform to enable further study into the causes and complications of diabetes. The study was originally established by the Royal Devon and Exeter Hospital in 2007 and was later rolled out nationwide through the clinical research networks in order to achieve recruitment targets. This agreement relates to the North East London Diabetes Research Network region of the study only, and is led by Barts Health NHS Trust, in collaboration with Queen Mary University of London, with whom they also share a research facility.

The study combines clinical, laboratory, molecular and genetic information to improve understanding of Type 1, Type 2 and other forms of diabetes and their associated complications. The aim of this study is to establish an epidemiologically based sample of all patients with diabetes within the regions included in the Diabetes Research Network (DRN). By collecting the same non-invasive samples as per clinical care it will be possible to perform tests to look for markers of the complications of diabetes. DNA will be taken from all consenting patients and molecular and genetic information will be combined with clinical information to provide a resource to look for gene/environment interaction in the development of Type 1, Type 2 and other forms of diabetes and their associated complications. The recruitment phase of DARE for both people with diabetes and controls is currently closed and all DNA from previous participants has been extracted and retained for analysing purposes only.

It is planned that, for all patients recruited in the study, there will be ongoing data collection that will be in parallel with data collected for clinical purposes. Close liaison between clinical and research services has resulted in a mutual benefit to both clinical and research aims. The specific sources are as follows:

1. Biochemical data from the Biochemistry/Chemical Pathology Laboratories. Direct computer links with clinical databases where present will be an advantage.

2. Basic clinical details will also be collected such as blood pressure, medication and weight. These will be part of the routinely collected clinical data.

3. Flagging of patients’ and controls’ records on the NHS register with NHS Digital). This will be done using patient details e.g. name, address and NHS number. This will enable information on when patients die and information on their death certificate to be used in this study in order to update the database and ensure appropriate referrals to further National Institute for Health Research (NIHR) approved studies.

The data requested is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller (covered by Article 6 (1)(e) of GDPR). NHS Digital are satisfied that this request is appropriate, necessary and proportionate for the performance of the task described in the Purpose statement and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects..

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 – in line with Article 9 (2)(j) of GDPR.

NHS Digital has determined that the processing in this application is not incompatible with the consent and is likely to be within the reasonable expectations of those that have consented. Participants were given a Participant Information Sheet and consent form, which fulfils the common law duty of confidentiality (Reasonable Expectations).

The main output is an up-to-date database for the DARE study which means that the study team can contact their members about research opportunities when they become available. The DARE study team will also be holding a series of public engagement events with researchers and clinicians. The first such event was on 13th November 2018 where they invited people from the database to listen to presentations on diabetes research which they may be interested in. The event was also attended by the charity Diabetes UK and latest information on diabetes and self management was distributed. Members were also allowed to vote on future presentations and make recommendations. The day was highly evaluated and a report was sent to all invited members. The study team also have a twitter account to promote such events. Another large event is being planned in the autumn of 2019.

The DARE study team also intend to email and post a twice yearly newsletter giving latest information on diabetes research and other relevant material to members. The first newsletter is anticipated to be in Spring 2019. It is the study team's intention to submit abstracts and presentations for relevant diabetes professional conferences e.g. Diabetes UK and International Diabetes Federation and publish our findings in appropriate journals e.g. Diabetic Medicine.

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

The DARE study continues to contribute to the recruitment of participants to ethically approved NIHR portfolio studies and to date this has assisted 30 studies and involved 4000 people. These studies are aimed at either finding a cure for diabetes or improving health of those with diabetes. Some studies are also qualitative focused and patient driven in nature. For example, the Diabetes Essentials Care Survey asks participants about the diabetes care they receive in primary care and will generate information for participating GPs.

The next yielded benefit is to make reports to local CCGs on the findings, which could have a beneficial effect on service provision and relationships between research and care pathways. There are also other clinical studies for people with diabetes and chronic kidney conditions. The purpose of this longitudinal study is to understand the progress of renal complications in diabetes and how they develop over time. Having this database has therefore accelerated the research process and provided evidence which has improved health care provision in many different areas of diabetes. The benefit for DARE members is that they have access to some of the latest research studies which they may be interested in and that they can have a voice in the care they receive. Furthermore, DARE have initiated public events where participants of studies can come and listen to the results of studies they have an interest in. The yielded benefit to them as a network is that more researchers are requesting help from the database and this is accelerating research further.

The Diabetes Alliance for Research in England (DARE) study was established in order to understand the cause of diabetes and its complications such as heart disease, diabetic eye disease and diabetic kidney disease, and to improve treatment and prevention of these important illnesses, the DARE study team need to find both the genes (the inherited code which may be passed down through generations) and also non-inherited factors that make some people more likely to get diabetes and the medical problems related to diabetes. This research study is a nationwide collaboration between patients and professionals to provide a platform to enable further study into the causes and complications of diabetes. The study was originally established by the Royal Devon and Exeter Hospital in 2007 and was later rolled out nationwide through the clinical research networks in order to achieve recruitment targets. This agreement relates to the North East London Diabetes Research Network region of the study only, and is led by Barts Health NHS Trust, in collaboration with Queen Mary University of London, with whom they also share a research facility.

The study combines clinical, laboratory, molecular and genetic information to improve understanding of Type 1, Type 2 and other forms of diabetes and their associated complications. The aim of this study is to establish an epidemiologically based sample of all patients with diabetes within the regions included in the Diabetes Research Network (DRN). By collecting the same non-invasive samples as per clinical care it will be possible to perform tests to look for markers of the complications of diabetes. DNA will be taken from all consenting patients and molecular and genetic information will be combined with clinical information to provide a resource to look for gene/environment interaction in the development of Type 1, Type 2 and other forms of diabetes and their associated complications. The recruitment phase of DARE for both people with diabetes and controls is currently closed and all DNA from previous participants has been extracted and retained for analysing purposes only.

It is planned that, for all patients recruited in the study, there will be ongoing data collection that will be in parallel with data collected for clinical purposes. Close liaison between clinical and research services has resulted in a mutual benefit to both clinical and research aims. The specific sources are as follows:

1. Biochemical data from the Biochemistry/Chemical Pathology Laboratories. Direct computer links with clinical databases where present will be an advantage.

2. Basic clinical details will also be collected such as blood pressure, medication and weight. These will be part of the routinely collected clinical data.

3. Flagging of patients’ and controls’ records on the NHS register with NHS Digital). This will be done using patient details e.g. name, address and NHS number. This will enable information on when patients die and information on their death certificate to be used in this study in order to update the database and ensure appropriate referrals to further National Institute for Health Research (NIHR) approved studies.

The data requested is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller (covered by Article 6 (1)(e) of GDPR). NHS Digital are satisfied that this request is appropriate, necessary and proportionate for the performance of the task described in the Purpose statement and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects..

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 – in line with Article 9 (2)(j) of GDPR.

NHS Digital has determined that the processing in this application is not incompatible with the consent and is likely to be within the reasonable expectations of those that have consented. Participants were given a Participant Information Sheet and consent form, which fulfils the common law duty of confidentiality (Reasonable Expectations).

The main output is an up-to-date database for the DARE study which means that the study team can contact their members about research opportunities when they become available. The DARE study team will also be holding a series of public engagement events with researchers and clinicians. The first such event was on 13th November 2018 where they invited people from the database to listen to presentations on diabetes research which they may be interested in. The event was also attended by the charity Diabetes UK and latest information on diabetes and self management was distributed. Members were also allowed to vote on future presentations and make recommendations. The day was highly evaluated and a report was sent to all invited members. The study team also have a twitter account to promote such events. Another large event is being planned in the autumn of 2019.

The DARE study team also intend to email and post a twice yearly newsletter giving latest information on diabetes research and other relevant material to members. The first newsletter is anticipated to be in Spring 2019. It is the study team's intention to submit abstracts and presentations for relevant diabetes professional conferences e.g. Diabetes UK and International Diabetes Federation and publish our findings in appropriate journals e.g. Diabetic Medicine.

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

The DARE study continues to contribute to the recruitment of participants to ethically approved NIHR portfolio studies and to date this has assisted 30 studies and involved 4000 people. These studies are aimed at either finding a cure for diabetes or improving health of those with diabetes. Some studies are also qualitative focused and patient driven in nature. For example, the Diabetes Essentials Care Survey asks participants about the diabetes care they receive in primary care and will generate information for participating GPs.

The next yielded benefit is to make reports to local CCGs on the findings, which could have a beneficial effect on service provision and relationships between research and care pathways. There are also other clinical studies for people with diabetes and chronic kidney conditions. The purpose of this longitudinal study is to understand the progress of renal complications in diabetes and how they develop over time. Having this database has therefore accelerated the research process and provided evidence which has improved health care provision in many different areas of diabetes. The benefit for DARE members is that they have access to some of the latest research studies which they may be interested in and that they can have a voice in the care they receive. Furthermore, DARE have initiated public events where participants of studies can come and listen to the results of studies they have an interest in. The yielded benefit to them as a network is that more researchers are requesting help from the database and this is accelerating research further.