The Salford integrated Record (SIR) and Type 1 Diabetes Outcomes

  • Research type

    Research Study

  • Full title

    Longitudinal study examining the prevalence of vascular complication of Type 1 Diabetes in Salford

  • IRAS ID

    324632

  • Contact name

    Adrian Hugh Heald

  • Contact email

    adrian.heald@nca.nhs.uk

  • Sponsor organisation

    Northern Care Alliance NHS Foundation Trust

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    The population to be studied will include everyone diagnosed with Type 1 diabetes (T1D) and registered with a general practitioner in Salford from 1 Jan 2000 until 30 November 2023. We will include those people who have died in the intervening period and those who have been diagnosed with T1D in the intervening period. The data is already held within a secure data haven environment, the Salford Integrated Record (SIR). This holds the GP coded data and some limited secondary care data for all people registered with a GP in Salford since the late 1990s. All data extracted will be fully anonymised prior to extraction.
    The Salford Integrated Record Research Database (known as SIR-RD) was established in 2009. Its aim is to create a pool of anonymized data from Salford patient's primary care records (that is GP records) to enable research into health conditions affecting the Salford population. It also sought to bring in research investment into Salford to benefit health, jobs and local services.
    The data to be extracted will be a mixture of clinically coded diagnoses outcomes including all-cause mortality, recorded observations, laboratory data, prescribing data and sociodemographic information.
    There are no plans to extract data other than that held in the SIR-RD. No individual patient will be contacted although we will be regularly informing patients about the progress with the work through our GP link network, through the Research for the Future patient engagement network and through Diabetes UK.

    Our aims are:
    Primary Outcome:
    1) How presence, or degree of renal damage (measured separately by lower estimated GFR calculated from serum creatinine or elevated urine albumin/protein-to-creatinine ratio) in T1D relates to cardiovascular outcomes over time.
    2) How the development of new-onset Diabetes Retinopathy or changes in retinopathy and maculopathy grade during the follow-up period.

    Secondary Outcomes: Determining how specific pharmacotherapy may mitigate the adverse cardiovascular effects of renal damage (measured separately by lower estimated GFR or elevated urine albumin/protein-to-creatinine ratio). Investigating how HbA1c levels over time, along with other factors such as age, sociodemographic situation, ethnicity, comorbidities, and related serological factors, influence this association.

  • REC name

    West of Scotland REC 4

  • REC reference

    23/WS/0175

  • Date of REC Opinion

    8 Mar 2024

  • REC opinion

    Further Information Favourable Opinion