Non-invasive glucose sensing with photonic chips v0.2

  • Research type

    Research Study

  • Full title

    Non-invasive Monitoring of Glucose in Diabetes Mellitus: A Pilot Study to Evaluate Photonic Chips as a Non-Invasive Glucose Sensor in Type 1 Diabetics in a Laboratory Prototype Device

  • IRAS ID

    336290

  • Contact name

    Ramzi Ajjan

  • Contact email

    r.ajjan@leeds.ac.uk

  • Sponsor organisation

    University of Leeds

  • Duration of Study in the UK

    0 years, 7 months, 28 days

  • Research summary

    People with diabetes monitor their blood glucose levels several times a day in order to maintain adequate control, helping them remain healthy. Usually, finger pricking is used to extract a small sample of blood which is then applied to a test strip which is read by a glucose monitor. We, at the university of Leeds, are in the process of developing a new method for glucose testing that avoids finger pricking to make glucose monitoring more convenient for the patient. The new device uses a laser at a safe power to monitor glucose in the body.

    An earlier prototype of the device has previously been tested in an early clinical study involving 12 patients with Type I diabetes at LICAMM, Faculty of Medicine, University of Leeds (REC ref. 13/YH/0075. IRAS project ID 64189). This first laboratory prototype of this non-invasive glucose monitor was compared with the finger prick method and a continuous glucose meter attached to the patient. The results from this study were encouraging but showed limitations in accuracy and repeatability. Recent research has focused on improving the device and data analysis methods which has culminated in a second-generation prototype aiming to increase the accuracy to enable subsequent clinical use. In this proposed study we will be testing the new prototypes to demonstrate measurement accuracy and ensure that the glucose readings do not vary with time. We will test the device with people of different ages to ensure consistent performance across the chosen population. However, we will be limiting the population to those with lighter skin tones as darker pigmentation in the skin may bring additional parameters for the data analysis which is beyond scope of the study at this time. There are no safety concerns with the device and the process of checking glucose levels is pain free.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    24/WM/0136

  • Date of REC Opinion

    17 Jul 2024

  • REC opinion

    Further Information Favourable Opinion