Quantifying Artificial Pancreas-related Changes in Diabetic NeQUANT-AP

  • Research type

    Research Study

  • Full title

    Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy

  • IRAS ID

    319534

  • Contact name

    Shazli Azmi

  • Contact email

    shazli.azmi@mft.nhs.uk

  • Sponsor organisation

    Manchester University NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05951283

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Patients with type 1 diabetes are prescribed multiple daily injections (MDI) of insulin to manage their glucose control. However, insulin pump therapy also known as continuous subcutaneous insulin infusion (CSII) and, more recently, the Artificial Pancreas (AP) can be used as the insulin delivery method. Diabetes, Endocrine and Metabolism Centre in Manchester is the first adult diabetes centre in Europe to pioneer and use a commercially-approved AP in clinical practice.

    AP has the advantage of being able to provide insulin at variable doses, which is closer to the natural process occurring within an individual without diabetes currently. It is considered to be the most physiological method of insulin delivery and has been shown to improve glycaemic control, quality of life and reduce the risk of hypoglycaemia (low blood glucose level).

    In this study we aim to investigate the effect of using AP on neuropathy. This will be in comparison to a control group of patients on MDI. We will use a variety of neuropathy measures and symptom questionnaires to assess structural and functional neuropathy status. We hypothesise that those patients receiving AP will demonstrate an improvement in symptoms and nerve regeneration.

    The findings would have a significant impact for patients as AP is already available on the NHS under certain considerations. This if this study shows benefit in this cohort it can be implemented immediately in clinical practice

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    23/LO/0833

  • Date of REC Opinion

    14 Nov 2023

  • REC opinion

    Further Information Favourable Opinion