Long-term vascular complications in young people with childhood-onset type 1 diabetes
University of Cambridge · Academic
In term In term in the September 2026 edition: the latest version runs to 5 February 2027.
- Reference
- DARS-NIC-316704-Z1Z7T
- Current version
- v3.2
- Term of current version
- 6 February 2026 to 5 February 2027
- Start date
- 4 May 2020
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 8
Why the data was released
Objective for processing
The University of Cambridge requires access to NHS England data for the purpose of the following research project: ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
The following is a summary of the aims of the research programme provided by the University of Cambridge:
Type 1 diabetes (T1D) is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.
The aim of the current project is to use to explore the impact of adolescent exposures to long-term outcomes and to enhance genetic association studies to identify determinants of long-term microvascular and macrovascular complications. The project will use three unique cohorts: the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and the Genetic Resource Investigating Diabetes (UK GRID).
Recruitment of the three cohorts ran between 1986 and 2005. During this time children and adolescents with type 1 diabetes were recruited to observational longitudinal studies, the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and Genetic Resource Investigating Diabetes (UK GRID), coordinated by the Department of Paediatrics, University of Cambridge. The University of Cambridge has collated these cohorts to form a total cohort population of 10,647 individuals.
Patients originally consented to the use of their personal data, however following discussion with NHS England regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Consequently, support under section 251 of the NHS Act 2006 was obtained in October 2019, to permit access to the data without informed consent.
The study team will use patient level data for the cohort of participants with NHS Numbers to determine the prevalence of cardiovascular events (Angina, Myocardial infarction, Stroke, Heart failure) and microvascular complications (retinopathy, microalbuminuria, macroalbuminuria, end stage renal disease, neuropathy).
Through linkage with the existing databases for the ORPS/NFS/GRID cohorts, it will be possible to link complications rates during adult life with risk factors, such as age at T1D diagnosis, T1D duration, glycaemic control, sex, albumin excretion rates, anthropometric parameters, blood pressure, lipid levels collected during childhood and adolescence. DNA samples collected from the ORPS/NFS/GRID cohorts provide genome wide association data (GWAS) data, which will permit the identification of potential genetic variants predisposing or protecting from complications. The data collected during childhood and adolescence from these cohorts are securely stored in an anonymised way in databases controlled by the Department of Paediatrics in Cambridge. These databases are kept separate from those containing identifiable data (NHS numbers, date of birth, gender).
The following NHS England Data will be accessed:
• Hospital Episode Statistics: Admitted Patient Care
• Civil Registration Mortality
• National Diabetes Audit (NDA)
These datasets are necessary to explore how early exposures relate to later microvascular and macrovascular complications.
The level of the Data will be:
• Pseudonymised
The Data will be minimised as follows:
• Limited to a study cohort of 10,647 individuals who consented to participate of which 8,680 are from England and Wales.
The University of Cambridge is research sponsor and the controller as the organisation 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.
The University of Cambridge (Department of Paediatrics) will use available departmental funds (Cambridge NIHR Biomedical Research Centre [BRC]) to undertake this project.
Cohort participants will be kept informed through website updates and publications from the Patient and Public Involvement advisory panel.
Processing activities
The University of Cambridge (Department of Paediatrics) will transfer data to NHS England. The data will consist of identifying details (specifically [NHS Number, Date of Birth, Postcode and a unique person ID) for the ORPS/NFS/GRID cohorts to be linked with NHS England data.
NHS England will provide the relevant records from the HES APC, NDA & mortality datasets to the University of Cambridge. 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.
At any stage of the above data flow, when patient data are not yet anonymous, only specific authorised members of staff will deal with the data under the supervision of the study data manager.
Once the data linkage of the remaining 1,967 cohort members the University does not hold confirmed NHS Numbers for is completed (under a subsequent amendment to this agreement), all identifiable data from the university databases will be erased, thereby relying solely on the Study ID for linkage. Timescales are dependent on CAG approval.
There will be no linkage to publicly available data and therefore there is no risk of re-identification through that route. There is no requirement to re-identify participants and no effort will be made to re-identify individual participants.
The Data will be stored on a Microsoft Access database located on the Secure Data Hosting Service (SDHS), which is managed by the Cambridge Clinical School Computing Service (CSCS)
Access to the data will be limited to members of the research team within the Department of Paediatrics, University of Cambridge, who have authorisation to access the data for the purposes described, all of whom are substantive employees of the University of Cambridge. Each user of the system will have an individual user account protected by a unique ID and password. Data files and transfer to personal computers or memory sticks is not permitted.
The data from NHS England will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.
Expected output
Expected outputs:
1. Data on the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life: this will provide important information on the dimension of the problem and how to prioritise resources to prevent specific complications
2. Identification of risk factors during childhood and adolescence linked to the development of vascular complications during adulthood: this will be invaluable to guide early interventions to prevent complications
3. Association between vascular complications and genetic variants emerging from ongoing genome-wide association studies and proteomic/metabolic biomarkers study of historical samples: this will provide more insight into mechanisms implicated in the development of complications and potentially guide the development of more targeted intervention strategies.
Outputs 1 and 2 should be available within 2 years from the beginning of the data linkage. Output 3 will require a longer time up to the end of 2023.
An end date of 2023 for the completion of all the data analyses is proposed.
Dissemination:
• Academic dissemination: Research findings will be disseminated through publication in scientific journals and conference presentations.
• Participants: the PPI advisory panel will communicate findings and results to participants.
• Public dissemination: Results will be presented to patients and clinicians, and discussed with the PPI advisory panel, who will help to develop appropriate materials for distribution to charities and patient groups. Study findings will be provided in lay language to the study participants, people with diabetes and the wider public though newsletters, departmental and diabetes charities (Diabetes UK, JDRF [Juvenile Diabetes Research Foundation]) websites and press releases.
• Engagement with critical stakeholders, diabetes charities, national and international support organisations (ISPAD [International Society for Paediatric and Adolescent Diabetes], NICE), national regional care providers to discuss key research findings and revising existing guidelines accordingly.
The data from NHS England will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.
Expected measurable benefits
Prevention of complications in young people with type 1 diabetes relies on the understanding of the factors which lead to these outcomes. ORPS/NFS/GRID are the largest studies ever undertaken in young people with type 1 diabetes and could help to better understand early risk factors for the development of vascular complications. This is critical for the development of preventative and intervention strategies to be implemented in future guidelines, to improve the prognosis of people with type 1 diabetes.
Because data on the prevalence of complications during adult life in people with an early diagnosis of type 1 diabetes is scant, a large study of this type over a 30-year period of individuals well into adulthood is likely to yield new and significant results. This should provide invaluable information on ways of improving early detection of vascular complications and implementation of timely interventions which could lead to an 'individualised management' strategies for young people with T1D.
Overall Impact: the early identification during adolescence of critical biomarkers which predict later complications could revolutionise the management of T1D through: 1) Assessment of risk for complications; 2) Discovery of novel pathways for intervention; 3) Discovery of novel treatment agents.
Type 1 diabetes affects around 28,000 children and adolescents in the UK1. With the prevalence doubling over the last 10 years and the age at presentation becoming earlier, leading to more people living with diabetes for longer and a higher number of people at risk of developing long-term complications, the impact of the research could potentially be significant.
Analysis of the relationship between adolescent exposures and vascular outcomes should be possible within 2 years. An end date of 2023 for the completion of all the data analyses is proposed.
Updates (October 2023) - University of Cambridge have encountered a few delays in running the data analysis. So far University of Cambridge have been able to review the received data and aiming to complete all analyses by end of December 2023.
Benefits reported so far
Clinical/Public benefit is still anticipated as the linkage will allow University of Cambridge to study the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life. The proposed research will provide invaluable information on ways of improving early detection of vascular complications and implementation of timely interventions which could lead to better and more targeted strategies for young people with T1D.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Civil Registrations of Death - Secondary Care Cut | Anonymised - ICO Code Compliant | Sensitive | One-Off | Section 251 NHS Act 2006 |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| National Diabetes Audit | Anonymised - ICO Code Compliant | Sensitive | One-Off | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were applied to all 8 files released under this agreement, across every version. About opt-outs
No files recorded as released under the current version. 8 were released under earlier versions, shown in the version history.
Version history
The register lists each renewal of this agreement as a separate row. This site has 4 versions.
DARS-NIC-316704-Z1Z7T-v3.2 6 February 2026 to 5 February 2027
- Title
- Long-term vascular complications in young people with childhood-onset type 1 diabetes
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC); National Diabetes Audit
What changed from DARS-NIC-316704-Z1Z7T-v2.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2026-02-06 | |
| End date | 2027-02-05 |
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.
DARS-NIC-316704-Z1Z7T-v2.2 1 February 2025 to 31 January 2026
- Title
- Long-term vascular complications in young people with childhood-onset type 1 diabetes
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC); National Diabetes Audit
What changed from DARS-NIC-316704-Z1Z7T-v1.7
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-02-01 | |
| End date | 2026-01-31 |
Objective for processing
Summary:
The University of Cambridge requires access to NHS England data for the purpose of the following research project: ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
The University of Cambridge (Department of Paediatrics) has requested data on rates of vascular complications, hospital admissions and mortality for the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and the Genetic Resource Investigating Diabetes (UK GRID) cohorts through limited access to National Diabetes Audit, Hospital Episodes Statistics and Civil Registrations data for use in the research project ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
The following is a summary of the aims of the research programme provided by the University of Cambridge:
The University of Cambridge is the Data Processor which also processes data. It is the only organisation involved.
Type 1 diabetes (T1D) is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.
The aim of the current project is to use to explore the impact of adolescent exposures to long-term outcomes and to enhance genetic association studies to identify determinants of long-term microvascular and macrovascular complications. The project will use three unique cohorts: the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and the Genetic Resource Investigating Diabetes (UK GRID).
Recruitment of the three cohorts ran between 1986 and 2005. During this time children and adolescents with type 1 diabetes were recruited to observational longitudinal studies, the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and Genetic Resource Investigating Diabetes (UK GRID), coordinated by the Department of Paediatrics, University of Cambridge. The University of Cambridge has collated these cohorts to form a total cohort population of 10,647 individuals.
Patients originally consented to the use of their personal data, however following discussion with NHS England regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Consequently, support under section 251 of the NHS Act 2006 was obtained in October 2019, to permit access to the data without informed consent.
The study team will use patient level data for the cohort of participants with NHS Numbers to determine the prevalence of cardiovascular events (Angina, Myocardial infarction, Stroke, Heart failure) and microvascular complications (retinopathy, microalbuminuria, macroalbuminuria, end stage renal disease, neuropathy).
Through linkage with the existing databases for the ORPS/NFS/GRID cohorts, it will be possible to link complications rates during adult life with risk factors, such as age at T1D diagnosis, T1D duration, glycaemic control, sex, albumin excretion rates, anthropometric parameters, blood pressure, lipid levels collected during childhood and adolescence. DNA samples collected from the ORPS/NFS/GRID cohorts provide genome wide association data (GWAS) data, which will permit the identification of potential genetic variants predisposing or protecting from complications. The data collected during childhood and adolescence from these cohorts are securely stored in an anonymised way in databases controlled by the Department of Paediatrics in Cambridge. These databases are kept separate from those containing identifiable data (NHS numbers, date of birth, gender).
The following NHS England Data will be accessed:
• Hospital Episode Statistics: Admitted Patient Care
• Civil Registration Mortality
• National Diabetes Audit (NDA)
These datasets are necessary to explore how early exposures relate to later microvascular and macrovascular complications.
The level of the Data will be:
• Pseudonymised
The Data will be minimised as follows:
• Limited to a study cohort of 10,647 individuals who consented to participate of which 8,680 are from England and Wales.
The University of Cambridge is research sponsor and the controller as the organisation 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.
[2 paragraphs unchanged]
Background and aim of this project:
Type 1 diabetes (T1D) is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.
Recruitment of the three cohorts ran between 1986 and 2005. During this time children and adolescents with type 1 diabetes were recruited to observational longitudinal studies, the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and Genetic Resource Investigating Diabetes (UK GRID), coordinated by the Department of Paediatrics, University of Cambridge. The University of Cambridge has collated these cohorts to form a total cohort population of 10,647 individuals.
Patients originally consented to the use of their personal data, however following discussion with NHS England regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Therefore an application was made to obtain the required data using section 251 of the NHS Act 2006. In October 2019, approval was obtained from the Confidentiality Advisory Group (CAG reference 19/CAG/0150); in addition, Ethics approval was received from East of England - Cambridge South Research Ethics Committee (REC reference 19/EE/0263; IRAS project ID: 260986).
The aim of the current project is to use these unique cohorts (ORPS/NFS and UK GRID) to efficiently explore the impact of adolescent exposures to long-term outcomes and to enhance genetic association studies to identify determinants of long-term microvascular and macrovascular complications.
The National Diabetes Audit (NDA) along with Hospital Episodes Statistics and Civil Registrations data provide a unique opportunity to explore further how early exposures relate to later microvascular and macrovascular complications.
Cohort & Data Summary:
• The total number of participants within the cohort is 10,647 individuals, currently older than 16 years. Of this total figure, the University holds NHS numbers for 8,680 cohort members from England & Wales for the purpose of linkage to the datasets described below. The University will only be submitting identifiers for these 8,680 participants under this version of the agreement.
• Information on the incidence/prevalence and timing of micro- and macrovascular complications during adult life from ORPS/NFS/GRID participants will be obtained through linkage of cohort member data to the following datasets:
- National Diabetes Audit (NDA) – Core Dataset
The University of Cambridge requests annual NDA data for the years beginning 2015/16 to latest available (2017/18).
- Hospital Episode Statistics – Admitted Patient Care
The University requests access to HES APC data on all admissions for its ORPS/NFS/GRID cohort members for the years 2016/17 to latest available.
- Civil Registration – Deaths (Secondary Care Cut)
The University requests access to latest available date and cause of death for its ORPS/NFS/GRID cohort members.
For the datasets listed above, a list of the participants NHS numbers, sex and date of birth along with an anonymised study specific ID will be sent to NHS England, who will extract data related to complications from their databases and send those data back to the University of Cambridge only with the Study ID but no personal identifiers.
For the remaining cohort members, 1,967 cohort members, the University does not hold confirmed NHS Numbers within study data to perform this linkage. An amendment to the associated CAG approval is currently in progress in order to submit additional identifiers of cohort members to confirm NHS Numbers for this portion of the cohort. Once this is approved, the University will be seeking an amendment to the agreement to request confirmation of NHS Numbers and further linkage of the remaining cohort members to the datasets described above. Timescales are dependent on CAG approval.
• The study team has requested patient level data for the cohort of participants with NHS Numbers to determine the prevalence of cardiovascular events (Angina, Myocardial infarction, Stroke, Heart failure) and microvascular complications (retinopathy, microalbuminuria, macroalbuminuria, end stage renal disease, neuropathy), as determined by the National Diabetes Core Audit (NDA core) reports 2017/2018 2016/2017 and 2015/2016. HES admissions data and mortality data will be also requested.
• Through linkage with the existing databases for the ORPS/NFS/GRID cohorts, it will be possible to link complications rates during adult life with risk factors, such as age at T1D diagnosis, T1D duration, glycaemic control, sex, albumin excretion rates, anthropometric parameters, blood pressure, lipid levels collected during childhood and adolescence. DNA samples collected from the ORPS/NFS/GRID cohorts provide genome wide association data (GWAS) data, which will permit the identification of potential genetic variants predisposing or protecting from complications. The data collected during childhood and adolescence from these cohorts are securely stored in an anonymised way in databases controlled by the Department of Paediatrics in Cambridge. These databases are kept separate from those containing identifiable data (NHS numbers, date of birth, gender).
Legal basis:
Based on the General Data Protection Regulation (GDPR), the legal basis for processing data for the present proposal is:
1) Personal data – task carried out in the public interest Art 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;
2) Special categories of personal data (ie health data) – for scientific research purposes (Art 9(2j)): 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.
The flow of identifiers (NHS number, date of birth, plus Unique study ID) into NHS England is supported by Section 251 approval, CAG reference 19/CAG/0150, dated until 12/11/2023.
Processing activities
Data is requested for each patient in the cohort described above (ORPS/NFS and UK GRID).
The University of Cambridge (Department of Paediatrics) will transfer data to NHS England. The data will consist of identifying details (specifically [NHS Number, Date of Birth, Postcode and a unique person ID) for the ORPS/NFS/GRID cohorts to be linked with NHS England data.
The steps of the data flow will include:
NHS England will provide the relevant records from the HES APC, NDA & mortality datasets to the University of Cambridge. 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 University of Cambridge (Department of Paediatrics) will transfer a file of identifiers (NHS numbers, date of birth, plus Unique study ID) via secure, approved routes to NHS England (DARS Production team).
The Data will not be transferred to any other location.
- DARS Production team will link these identifiers to HES APC, NDA & mortality datasets using the identifiers from the ORPS/NFS/GRID cohorts.
At any stage of the above data flow, when patient data are not yet anonymous, only specific authorised members of staff will deal with the data under the supervision of the study data manager.
- DARS Production team send linked HES, NDA and Civil registration data to University of Cambridge with the only identifier present being Study ID.
- University of Cambridge link the data received from NHS England with the cohort datasets, using consistent Study IDs.
Data will be returned to the University of Cambridge in a pseudonymised form where participants are identified only by the unique Study ID without any other identifiable information. At any stage of the above data flow, when patient data are not yet anonymous, only specific authorised members of staff will deal with the data under the supervision of the study data manager.
[2 paragraphs unchanged]
Data storage:
The Data will be stored on a Microsoft Access database located on the Secure Data Hosting Service (SDHS), which is managed by the Cambridge Clinical School Computing Service (CSCS)
The data obtained through NHS England will be held on a Microsoft Access database located on the Secure Data Hosting Service (SDHS), which is managed by the Cambridge Clinical School Computing Service (CSCS) and is run within the Information Governance Office on behalf of the School. The SDHS provides a Safe Haven for members of the School to store sensitive data, including Personally Identifiable Data in a manner compliant with School Policy (https://www.medschl.cam.ac.uk/research/information-governance/the-secure-data-hosting-service/).
[1 paragraph unchanged]
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).
[1 paragraph unchanged]
Expected measurable benefits
[5 paragraphs unchanged]
Updates (October 2023) -
we
University of Cambridge
have encountered a few delays in running the data analysis.
so
So
far
we
University of Cambridge
have been able to review the received data and aiming to complete all analyses by end of December 2023.
Benefits reported
There are no yielded benefits yet for this project as the data analysis is still in progress.
Clinical/Public benefit is still anticipated as the linkage will allow University of Cambridge to study the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life. The proposed research will provide invaluable information on ways of improving early detection of vascular complications and implementation of timely interventions which could lead to better and more targeted strategies for young people with T1D.
Unchanged: Expected output.
Objective for processing
The University of Cambridge requires access to NHS England data for the purpose of the following research project: ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
The following is a summary of the aims of the research programme provided by the University of Cambridge:
Type 1 diabetes (T1D) is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.
The aim of the current project is to use to explore the impact of adolescent exposures to long-term outcomes and to enhance genetic association studies to identify determinants of long-term microvascular and macrovascular complications. The project will use three unique cohorts: the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and the Genetic Resource Investigating Diabetes (UK GRID).
Recruitment of the three cohorts ran between 1986 and 2005. During this time children and adolescents with type 1 diabetes were recruited to observational longitudinal studies, the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and Genetic Resource Investigating Diabetes (UK GRID), coordinated by the Department of Paediatrics, University of Cambridge. The University of Cambridge has collated these cohorts to form a total cohort population of 10,647 individuals.
Patients originally consented to the use of their personal data, however following discussion with NHS England regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Consequently, support under section 251 of the NHS Act 2006 was obtained in October 2019, to permit access to the data without informed consent.
The study team will use patient level data for the cohort of participants with NHS Numbers to determine the prevalence of cardiovascular events (Angina, Myocardial infarction, Stroke, Heart failure) and microvascular complications (retinopathy, microalbuminuria, macroalbuminuria, end stage renal disease, neuropathy).
Through linkage with the existing databases for the ORPS/NFS/GRID cohorts, it will be possible to link complications rates during adult life with risk factors, such as age at T1D diagnosis, T1D duration, glycaemic control, sex, albumin excretion rates, anthropometric parameters, blood pressure, lipid levels collected during childhood and adolescence. DNA samples collected from the ORPS/NFS/GRID cohorts provide genome wide association data (GWAS) data, which will permit the identification of potential genetic variants predisposing or protecting from complications. The data collected during childhood and adolescence from these cohorts are securely stored in an anonymised way in databases controlled by the Department of Paediatrics in Cambridge. These databases are kept separate from those containing identifiable data (NHS numbers, date of birth, gender).
The following NHS England Data will be accessed:
• Hospital Episode Statistics: Admitted Patient Care
• Civil Registration Mortality
• National Diabetes Audit (NDA)
These datasets are necessary to explore how early exposures relate to later microvascular and macrovascular complications.
The level of the Data will be:
• Pseudonymised
The Data will be minimised as follows:
• Limited to a study cohort of 10,647 individuals who consented to participate of which 8,680 are from England and Wales.
The University of Cambridge is research sponsor and the controller as the organisation 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.
The University of Cambridge (Department of Paediatrics) will use available departmental funds (Cambridge NIHR Biomedical Research Centre [BRC]) to undertake this project.
Cohort participants will be kept informed through website updates and publications from the Patient and Public Involvement advisory panel.
Expected output
Expected outputs:
1. Data on the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life: this will provide important information on the dimension of the problem and how to prioritise resources to prevent specific complications
2. Identification of risk factors during childhood and adolescence linked to the development of vascular complications during adulthood: this will be invaluable to guide early interventions to prevent complications
3. Association between vascular complications and genetic variants emerging from ongoing genome-wide association studies and proteomic/metabolic biomarkers study of historical samples: this will provide more insight into mechanisms implicated in the development of complications and potentially guide the development of more targeted intervention strategies.
Outputs 1 and 2 should be available within 2 years from the beginning of the data linkage. Output 3 will require a longer time up to the end of 2023.
An end date of 2023 for the completion of all the data analyses is proposed.
Dissemination:
• Academic dissemination: Research findings will be disseminated through publication in scientific journals and conference presentations.
• Participants: the PPI advisory panel will communicate findings and results to participants.
• Public dissemination: Results will be presented to patients and clinicians, and discussed with the PPI advisory panel, who will help to develop appropriate materials for distribution to charities and patient groups. Study findings will be provided in lay language to the study participants, people with diabetes and the wider public though newsletters, departmental and diabetes charities (Diabetes UK, JDRF [Juvenile Diabetes Research Foundation]) websites and press releases.
• Engagement with critical stakeholders, diabetes charities, national and international support organisations (ISPAD [International Society for Paediatric and Adolescent Diabetes], NICE), national regional care providers to discuss key research findings and revising existing guidelines accordingly.
The data from NHS England will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.
Benefits reported
Clinical/Public benefit is still anticipated as the linkage will allow University of Cambridge to study the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life. The proposed research will provide invaluable information on ways of improving early detection of vascular complications and implementation of timely interventions which could lead to better and more targeted strategies for young people with T1D.
DARS-NIC-316704-Z1Z7T-v1.7 12 December 2023 to 11 December 2024
- Title
- Long-term vascular complications in young people with childhood-onset type 1 diabetes
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC); National Diabetes Audit
What changed from DARS-NIC-316704-Z1Z7T-v0.28
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2023-12-12 | |
| End date | 2024-12-11 | |
| Civil Registrations of Death - Secondary Care Cut: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. | |
| National Diabetes Audit: legal basis | Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. |
Objective for processing
Summary
Summary:
The University of Cambridge (Department of Paediatrics)
requests
has requested
data on rates of vascular complications, hospital admissions and mortality for the
[36 words unchanged]
project ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
[3 paragraphs unchanged]
Background and aim of this
project
project:
[2 paragraphs unchanged]
Patients originally consented to the use of their personal data, however following discussion with NHS
Digital
England
regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations
[63 words unchanged]
Cambridge South Research Ethics Committee (REC reference 19/EE/0263; IRAS project ID: 260986).
[2 paragraphs unchanged]
Cohort & Data
Summary
Summary:
[8 paragraphs unchanged]
For the datasets listed above, a list of the participants NHS numbers,
[5 words unchanged]
along with an anonymised study specific ID will be sent to NHS
Digital,
England,
who will extract data related to complications from their databases and send
[5 words unchanged]
University of Cambridge only with the Study ID but no personal identifiers.
[1 paragraph unchanged]
• The study team
will request
has requested
patient level data for the cohort of participants with NHS Numbers to
[36 words unchanged]
and 2015/2016. HES admissions data and mortality data will be also requested.
[1 paragraph unchanged]
Legal
basis;
basis:
[3 paragraphs unchanged]
The flow of identifiers (NHS number, date of birth, plus Unique study ID) into NHS
Digital
England
is supported by Section 251 approval, CAG reference 19/CAG/0150, dated
12/11/2019.
until 12/11/2023.
Processing activities
[2 paragraphs unchanged]
- The University of Cambridge (Department of Paediatrics) will transfer a file
[5 words unchanged]
of birth, plus Unique study ID) via secure, approved routes to NHS
Digital
England
(DARS Production team).
[2 paragraphs unchanged]
- University of Cambridge link the data received from NHS
Digital
England
with the cohort datasets, using consistent Study IDs.
[3 paragraphs unchanged]
Data
storage
storage:
The data obtained through NHS
Digital
England
will be held on a Microsoft Access database located on the Secure
[43 words unchanged]
including Personally Identifiable Data in a manner compliant with School Policy (https://www.medschl.cam.ac.uk/research/information-governance/the-secure-data-hosting-service/).
[2 paragraphs unchanged]
The data from NHS
Digital
England
will not be used for any other purpose other than that outlined
[9 words unchanged]
aggregate data with small numbers suppressed in line with HES Analysis Guide.
Expected output
Expected
outputs
outputs:
[10 paragraphs unchanged]
The data from NHS
Digital
England
will not be used for any other purpose other than that outlined
[9 words unchanged]
aggregate data with small numbers suppressed in line with HES Analysis Guide.
Expected measurable benefits
[5 paragraphs unchanged] Updates (October 2023) - we have encountered a few delays in running the data analysis. so far we have been able to review the received data and aiming to complete all analyses by end of December 2023.
Benefits reported
Yielded Benefits is not a requirement for new applications.
There are no yielded benefits yet for this project as the data analysis is still in progress.
Objective for processing
Summary:
The University of Cambridge (Department of Paediatrics) has requested data on rates of vascular complications, hospital admissions and mortality for the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and the Genetic Resource Investigating Diabetes (UK GRID) cohorts through limited access to National Diabetes Audit, Hospital Episodes Statistics and Civil Registrations data for use in the research project ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
The University of Cambridge is the Data Processor which also processes data. It is the only organisation involved.
The University of Cambridge (Department of Paediatrics) will use available departmental funds (Cambridge NIHR Biomedical Research Centre [BRC]) to undertake this project.
Cohort participants will be kept informed through website updates and publications from the Patient and Public Involvement advisory panel.
Background and aim of this project:
Type 1 diabetes (T1D) is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.
Recruitment of the three cohorts ran between 1986 and 2005. During this time children and adolescents with type 1 diabetes were recruited to observational longitudinal studies, the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and Genetic Resource Investigating Diabetes (UK GRID), coordinated by the Department of Paediatrics, University of Cambridge. The University of Cambridge has collated these cohorts to form a total cohort population of 10,647 individuals.
Patients originally consented to the use of their personal data, however following discussion with NHS England regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Therefore an application was made to obtain the required data using section 251 of the NHS Act 2006. In October 2019, approval was obtained from the Confidentiality Advisory Group (CAG reference 19/CAG/0150); in addition, Ethics approval was received from East of England - Cambridge South Research Ethics Committee (REC reference 19/EE/0263; IRAS project ID: 260986).
The aim of the current project is to use these unique cohorts (ORPS/NFS and UK GRID) to efficiently explore the impact of adolescent exposures to long-term outcomes and to enhance genetic association studies to identify determinants of long-term microvascular and macrovascular complications.
The National Diabetes Audit (NDA) along with Hospital Episodes Statistics and Civil Registrations data provide a unique opportunity to explore further how early exposures relate to later microvascular and macrovascular complications.
Cohort & Data Summary:
• The total number of participants within the cohort is 10,647 individuals, currently older than 16 years. Of this total figure, the University holds NHS numbers for 8,680 cohort members from England & Wales for the purpose of linkage to the datasets described below. The University will only be submitting identifiers for these 8,680 participants under this version of the agreement.
• Information on the incidence/prevalence and timing of micro- and macrovascular complications during adult life from ORPS/NFS/GRID participants will be obtained through linkage of cohort member data to the following datasets:
- National Diabetes Audit (NDA) – Core Dataset
The University of Cambridge requests annual NDA data for the years beginning 2015/16 to latest available (2017/18).
- Hospital Episode Statistics – Admitted Patient Care
The University requests access to HES APC data on all admissions for its ORPS/NFS/GRID cohort members for the years 2016/17 to latest available.
- Civil Registration – Deaths (Secondary Care Cut)
The University requests access to latest available date and cause of death for its ORPS/NFS/GRID cohort members.
For the datasets listed above, a list of the participants NHS numbers, sex and date of birth along with an anonymised study specific ID will be sent to NHS England, who will extract data related to complications from their databases and send those data back to the University of Cambridge only with the Study ID but no personal identifiers.
For the remaining cohort members, 1,967 cohort members, the University does not hold confirmed NHS Numbers within study data to perform this linkage. An amendment to the associated CAG approval is currently in progress in order to submit additional identifiers of cohort members to confirm NHS Numbers for this portion of the cohort. Once this is approved, the University will be seeking an amendment to the agreement to request confirmation of NHS Numbers and further linkage of the remaining cohort members to the datasets described above. Timescales are dependent on CAG approval.
• The study team has requested patient level data for the cohort of participants with NHS Numbers to determine the prevalence of cardiovascular events (Angina, Myocardial infarction, Stroke, Heart failure) and microvascular complications (retinopathy, microalbuminuria, macroalbuminuria, end stage renal disease, neuropathy), as determined by the National Diabetes Core Audit (NDA core) reports 2017/2018 2016/2017 and 2015/2016. HES admissions data and mortality data will be also requested.
• Through linkage with the existing databases for the ORPS/NFS/GRID cohorts, it will be possible to link complications rates during adult life with risk factors, such as age at T1D diagnosis, T1D duration, glycaemic control, sex, albumin excretion rates, anthropometric parameters, blood pressure, lipid levels collected during childhood and adolescence. DNA samples collected from the ORPS/NFS/GRID cohorts provide genome wide association data (GWAS) data, which will permit the identification of potential genetic variants predisposing or protecting from complications. The data collected during childhood and adolescence from these cohorts are securely stored in an anonymised way in databases controlled by the Department of Paediatrics in Cambridge. These databases are kept separate from those containing identifiable data (NHS numbers, date of birth, gender).
Legal basis:
Based on the General Data Protection Regulation (GDPR), the legal basis for processing data for the present proposal is:
1) Personal data – task carried out in the public interest Art 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;
2) Special categories of personal data (ie health data) – for scientific research purposes (Art 9(2j)): 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.
The flow of identifiers (NHS number, date of birth, plus Unique study ID) into NHS England is supported by Section 251 approval, CAG reference 19/CAG/0150, dated until 12/11/2023.
Expected output
Expected outputs:
1. Data on the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life: this will provide important information on the dimension of the problem and how to prioritise resources to prevent specific complications
2. Identification of risk factors during childhood and adolescence linked to the development of vascular complications during adulthood: this will be invaluable to guide early interventions to prevent complications
3. Association between vascular complications and genetic variants emerging from ongoing genome-wide association studies and proteomic/metabolic biomarkers study of historical samples: this will provide more insight into mechanisms implicated in the development of complications and potentially guide the development of more targeted intervention strategies.
Outputs 1 and 2 should be available within 2 years from the beginning of the data linkage. Output 3 will require a longer time up to the end of 2023.
An end date of 2023 for the completion of all the data analyses is proposed.
Dissemination:
• Academic dissemination: Research findings will be disseminated through publication in scientific journals and conference presentations.
• Participants: the PPI advisory panel will communicate findings and results to participants.
• Public dissemination: Results will be presented to patients and clinicians, and discussed with the PPI advisory panel, who will help to develop appropriate materials for distribution to charities and patient groups. Study findings will be provided in lay language to the study participants, people with diabetes and the wider public though newsletters, departmental and diabetes charities (Diabetes UK, JDRF [Juvenile Diabetes Research Foundation]) websites and press releases.
• Engagement with critical stakeholders, diabetes charities, national and international support organisations (ISPAD [International Society for Paediatric and Adolescent Diabetes], NICE), national regional care providers to discuss key research findings and revising existing guidelines accordingly.
The data from NHS England will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.
Benefits reported
There are no yielded benefits yet for this project as the data analysis is still in progress.
DARS-NIC-316704-Z1Z7T-v0.28 4 May 2020 to 3 May 2023
- Title
- Long-term vascular complications in young people with childhood-onset type 1 diabetes
- Commercial
- No
- Sublicensing
- No
- Datasets
- 3
- Files released
- 8
Datasets: Civil Registrations of Death - Secondary Care Cut; Hospital Episode Statistics Admitted Patient Care (HES APC); National Diabetes Audit
Objective for processing
Summary
The University of Cambridge (Department of Paediatrics) requests data on rates of vascular complications, hospital admissions and mortality for the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and the Genetic Resource Investigating Diabetes (UK GRID) cohorts through limited access to National Diabetes Audit, Hospital Episodes Statistics and Civil Registrations data for use in the research project ‘Long-term vascular complications in young people with childhood-onset type 1 diabetes'.
The University of Cambridge is the Data Processor which also processes data. It is the only organisation involved.
The University of Cambridge (Department of Paediatrics) will use available departmental funds (Cambridge NIHR Biomedical Research Centre [BRC]) to undertake this project.
Cohort participants will be kept informed through website updates and publications from the Patient and Public Involvement advisory panel.
Background and aim of this project
Type 1 diabetes (T1D) is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.
Recruitment of the three cohorts ran between 1986 and 2005. During this time children and adolescents with type 1 diabetes were recruited to observational longitudinal studies, the Oxford Regional Prospective Study (ORPS)/Nephropathy Family Study (NFS) and Genetic Resource Investigating Diabetes (UK GRID), coordinated by the Department of Paediatrics, University of Cambridge. The University of Cambridge has collated these cohorts to form a total cohort population of 10,647 individuals.
Patients originally consented to the use of their personal data, however following discussion with NHS Digital regarding linkages to the National Diabetes Audit (NDA), HES and Civil Registrations data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Therefore an application was made to obtain the required data using section 251 of the NHS Act 2006. In October 2019, approval was obtained from the Confidentiality Advisory Group (CAG reference 19/CAG/0150); in addition, Ethics approval was received from East of England - Cambridge South Research Ethics Committee (REC reference 19/EE/0263; IRAS project ID: 260986).
The aim of the current project is to use these unique cohorts (ORPS/NFS and UK GRID) to efficiently explore the impact of adolescent exposures to long-term outcomes and to enhance genetic association studies to identify determinants of long-term microvascular and macrovascular complications.
The National Diabetes Audit (NDA) along with Hospital Episodes Statistics and Civil Registrations data provide a unique opportunity to explore further how early exposures relate to later microvascular and macrovascular complications.
Cohort & Data Summary
• The total number of participants within the cohort is 10,647 individuals, currently older than 16 years. Of this total figure, the University holds NHS numbers for 8,680 cohort members from England & Wales for the purpose of linkage to the datasets described below. The University will only be submitting identifiers for these 8,680 participants under this version of the agreement.
• Information on the incidence/prevalence and timing of micro- and macrovascular complications during adult life from ORPS/NFS/GRID participants will be obtained through linkage of cohort member data to the following datasets:
- National Diabetes Audit (NDA) – Core Dataset
The University of Cambridge requests annual NDA data for the years beginning 2015/16 to latest available (2017/18).
- Hospital Episode Statistics – Admitted Patient Care
The University requests access to HES APC data on all admissions for its ORPS/NFS/GRID cohort members for the years 2016/17 to latest available.
- Civil Registration – Deaths (Secondary Care Cut)
The University requests access to latest available date and cause of death for its ORPS/NFS/GRID cohort members.
For the datasets listed above, a list of the participants NHS numbers, sex and date of birth along with an anonymised study specific ID will be sent to NHS Digital, who will extract data related to complications from their databases and send those data back to the University of Cambridge only with the Study ID but no personal identifiers.
For the remaining cohort members, 1,967 cohort members, the University does not hold confirmed NHS Numbers within study data to perform this linkage. An amendment to the associated CAG approval is currently in progress in order to submit additional identifiers of cohort members to confirm NHS Numbers for this portion of the cohort. Once this is approved, the University will be seeking an amendment to the agreement to request confirmation of NHS Numbers and further linkage of the remaining cohort members to the datasets described above. Timescales are dependent on CAG approval.
• The study team will request patient level data for the cohort of participants with NHS Numbers to determine the prevalence of cardiovascular events (Angina, Myocardial infarction, Stroke, Heart failure) and microvascular complications (retinopathy, microalbuminuria, macroalbuminuria, end stage renal disease, neuropathy), as determined by the National Diabetes Core Audit (NDA core) reports 2017/2018 2016/2017 and 2015/2016. HES admissions data and mortality data will be also requested.
• Through linkage with the existing databases for the ORPS/NFS/GRID cohorts, it will be possible to link complications rates during adult life with risk factors, such as age at T1D diagnosis, T1D duration, glycaemic control, sex, albumin excretion rates, anthropometric parameters, blood pressure, lipid levels collected during childhood and adolescence. DNA samples collected from the ORPS/NFS/GRID cohorts provide genome wide association data (GWAS) data, which will permit the identification of potential genetic variants predisposing or protecting from complications. The data collected during childhood and adolescence from these cohorts are securely stored in an anonymised way in databases controlled by the Department of Paediatrics in Cambridge. These databases are kept separate from those containing identifiable data (NHS numbers, date of birth, gender).
Legal basis;
Based on the General Data Protection Regulation (GDPR), the legal basis for processing data for the present proposal is:
1) Personal data – task carried out in the public interest Art 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;
2) Special categories of personal data (ie health data) – for scientific research purposes (Art 9(2j)): 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.
The flow of identifiers (NHS number, date of birth, plus Unique study ID) into NHS Digital is supported by Section 251 approval, CAG reference 19/CAG/0150, dated 12/11/2019.
Expected output
Expected outputs
1. Data on the prevalence of vascular complications and mortality in the ORPS/NFS/GRID cohorts during adult life: this will provide important information on the dimension of the problem and how to prioritise resources to prevent specific complications
2. Identification of risk factors during childhood and adolescence linked to the development of vascular complications during adulthood: this will be invaluable to guide early interventions to prevent complications
3. Association between vascular complications and genetic variants emerging from ongoing genome-wide association studies and proteomic/metabolic biomarkers study of historical samples: this will provide more insight into mechanisms implicated in the development of complications and potentially guide the development of more targeted intervention strategies.
Outputs 1 and 2 should be available within 2 years from the beginning of the data linkage. Output 3 will require a longer time up to the end of 2023.
An end date of 2023 for the completion of all the data analyses is proposed.
Dissemination:
• Academic dissemination: Research findings will be disseminated through publication in scientific journals and conference presentations.
• Participants: the PPI advisory panel will communicate findings and results to participants.
• Public dissemination: Results will be presented to patients and clinicians, and discussed with the PPI advisory panel, who will help to develop appropriate materials for distribution to charities and patient groups. Study findings will be provided in lay language to the study participants, people with diabetes and the wider public though newsletters, departmental and diabetes charities (Diabetes UK, JDRF [Juvenile Diabetes Research Foundation]) websites and press releases.
• Engagement with critical stakeholders, diabetes charities, national and international support organisations (ISPAD [International Society for Paediatric and Adolescent Diabetes], NICE), national regional care providers to discuss key research findings and revising existing guidelines accordingly.
The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.
-
July 2021 —
already listed in the earliest edition this site holds, so it may be older. 1 version: DARS-NIC-316704-Z1Z7T-v0.28
-
January 2024
1 version added: DARS-NIC-316704-Z1Z7T-v1.7
-
March 2025
1 version added: DARS-NIC-316704-Z1Z7T-v2.2
-
April 2026
1 version added: DARS-NIC-316704-Z1Z7T-v3.2
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-316704-Z1Z7T, “Long-term vascular complications in young people with childhood-onset type 1 diabetes”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-316704-z1z7t/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-316704-Z1Z7T to see the original rows.