FreeStyle Libre monitoring in T2DM

  • Research type

    Research Study

  • Full title

    Effect of introduction of FreeStyle Libre monitoring on glycaemic control in people with type 2 diabetes mellitus (T2DM)

  • IRAS ID

    301630

  • Contact name

    Thozhukat Sathyapalan

  • Contact email

    thozhukat.sathyapalan@hyms.ac.uk

  • Sponsor organisation

    Hull University Teaching Hospitals NHS Trust

  • Clinicaltrials.gov Identifier

    NCT05597293

  • Duration of Study in the UK

    0 years, 6 months, 2 days

  • Research summary

    Type 2 diabetes(T2D) is a global health problem resulting in a variety of life-changing complications that can be minimized by effective sugar control. There are numerous oral and injectable medications including insulin which are used to treat T2D worldwide. FreeStyle Libre (FSL)monitoring is a form of glucose monitoring used in patients with Type 1 diabetes(T1D)that has resulted in improved sugar control in patients. We believe that this effect seen in people with T1D can be seen in T2D as well, and if proven, will help to reduce medication burden and at the same time result in better sugar control. To assess whether FSL monitoring improves sugar control in people with T2D, we will recruit a total of 40 participants, randomly allocating 20 to receive the FreeStyle Libre 2 sensor system (Libre 2) and 20 to receive the FreeStyle Libre pro iQ monitoring system (Libre pro iQ)(glucose readings are masked from the patients so this will be the control group)and study the change in sugar control over 3 months. The recruitment process will take place at the Allam Diabetes Centre in the Hull Royal Infirmary. This study is sponsored by the R&D department of the Hull University Teaching Hospitals NHS Trust and is funded through the University of Hull.

  • REC name

    West Midlands - Black Country Research Ethics Committee

  • REC reference

    22/WM/0152

  • Date of REC Opinion

    10 Aug 2022

  • REC opinion

    Further Information Favourable Opinion