Non-Invasive Glucose Monitoring study (Version1)

• Research type

  Research Study

• Full title

  Non-invasive, and needle-free, continuous glucose monitor for children and young people living with diabetes.

• IRAS ID

  354992

• Contact name

  Julian Hamilton-Shield

• Contact email

  j.p.h.shield@bristol.ac.uk

• Sponsor organisation

  University of Bristol

• ISRCTN Number

  ISRCTN15382728

• Duration of Study in the UK

  0 years, 5 months, 31 days

• Research summary

  We want to find out if a prototype sensor that is placed on the skin once a day, can measure a child with diabetes ‘blood’ glucose levels accurately like the invasive Libre, Guardian or Dexcom continuous blood glucose monitors (CGM) currently used.
  This new ‘sensor’ does not need to be put into the skin with a needle and just gets stuck on the skin every day (non-invasive). The manufacturers of the sensor (Transdermal Diagnostics) believe this method will cause less pain and less skin wounds and scars.
  The sensor works by passing a very small electric current across the skin which extracts glucose through the hair follicles which can then be measured. The glucose will be what we call ‘interstitial’, which is what all sensors currently measure.
  This study will find out if the new sensor works well at accurately estimating blood glucose levels in the same way current continuous glucose monitors do. If it does, then we hope it can replace the sensors used now that are painful to put in and can cause a lot of skin problems in some young people.

  Thirty children and young people with diabetes will be asked to wear a new sensor each day (for 10 days) and do four finger prick blood tests so we can compare how the new sensor works compared to ‘Gold Standard’ blood tests. The results of the finger pricks should be recorded for time and date so we can compare to results from new sensor accurately. The new sensor results will not be visible to patients or families as we first need to know how accurate they are compared to true glucose readings. This means participants will continue with their current normal method to work out meal time insulin doses whether it is using current CGM or finger pricks.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  25/EE/0129

• Date of REC Opinion

  3 Jul 2025

• REC opinion

  Further Information Favourable Opinion