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SELFY - FreeStyle Libre Glucose Monitoring System Paediatric Study

  • Research type

    Research Study

  • Full title

    An Evaluation of Self-Management of Diabetes using FreeStyle Libre Flash Glucose Monitoring System in Young People

  • IRAS ID

    205130

  • Contact name

    Fiona Campbell

  • Contact email

    fiona.campbell26@nhs.net

  • Sponsor organisation

    Abbott Diabetes Care Ltd

  • Clinicaltrials.gov Identifier

    NCT02821117

  • Duration of Study in the UK

    0 years, 5 months, 9 days

  • Research summary

    The FreeStyle Libre Flash Glucose Monitoring System is indicated for measuring glucose levels in persons with diabetes from 4 years of age. This investigation will assess the use of the system in children with diabetes for their day to day self-management.\nSuccessful diabetes management is dependent upon effective self-management; children and adolescents with diabetes and their families need help and support to achieve this. The advantage of the FreeStyle Libre System is it significantly increases the amount and availability of detailed glucose data, while significantly reducing the time and pain issues of glucose monitoring. The on-body Sensor that can be worn for up to 14 days. Users can observe the current glucose level, glucose trend data and glucose patterns with minimal inconvenience by scanning a sensor worn on the back of the arm.\nIt is the intention of this clinical study to establish if the FreeStyle Libre System can help maintain glycaemic control in a paediatric population.\n\nThis Study is a multi-centre, prospective, single arm, non-significant risk evaluation of the System. \n\nThe target enrolment is approximately 70 subjects. Participants will be aged between 4 and 17 years using insulin by either injection (MDI) or by insulin pump therapy (CSII).\n\nFor this study, the Reader is “masked” for the first 14 days; to provide baseline data for the study analysis, during this time participants will use the Reader blood glucose strip port for routine self-monitoring during this time and not their current Blood Glucose system. After the first 14 days the system is unmasked and used by the participant according to the labelling as part of their glucose management. The study is estimated to last approximately 4 months and study participation will be a maximum of 103 days.

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference

    16/NS/0054

  • Date of REC Opinion

    13 May 2016

  • REC opinion

    Favourable Opinion