SENSE
Research type
Research Study
Full title
SENSE: A Study to Evaluate the Relationship between Novel Interstitial, Real-time Glucose Sensors and Reference Glucose Values in People with Diabetes Mellitus
IRAS ID
323476
Contact name
Amanda Adler
Contact email
Sponsor organisation
SAVA Technologies Ltd
Duration of Study in the UK
0 years, 7 months, 28 days
Research summary
SAVA, a London-based bioengineering start-up company has developed 2 new CGMs, called ‘biosensors’. The ‘microsensor’ biosensor has a novel and minimally invasive design with tiny needles to reduce discomfort and pain compared to currently available CGMs. The other ‘Filament’ biosensor has a soft filament, around 5 mm, similar to other CGMs already on the market. SAVA can produce and offer both biosensors at lower cost than other currently available models on the market.
The Diabetes Trials Unit, Oxford, is running a study to help SAVA develop and test this 2 new CGMs. The study will run in 2 parts. The first part (part A) focuses on collecting participants’ information for the development of an algorithm able to convert the biosensors’ electrical signals into glucose readings. The second part (part B) uses the newly generated algorithm to test whether the biosensors accurately measure blood glucose.
50 participants with diabetes treated with insulin will be recruited into the study and they will be divided into 2 groups of 25 each. The first group will help with the part A of the study, while the second group will be involved in study part B. All participants will wear the 2 SAVA biosensors and a commercially available CGM (FreeStyle Libre 3 or FreeStyle Libre 2 (FSL3/FSL2)) continuously for 10-12 days. Participants will not be able to see glucose values from the research biosensors, however, they can see these on the FSL3/FSL2.
Participants will attend a maximum of 4 visits within the 10–12-day period. After the baseline visit to place biosensors and the FSL3/FSL2, in the next 2 visits, the research team will collect blood (the reference measure) from a cannula placed in a participant’s arm every 10 to 15 minutes for 7 hours.
To assess the accuracy of the new biosensors, particularly when the glucose levels are outside the normal range, a sub group of 10 participants with type 1 diabetes, who have previously received DAFNE (or DAFNE-like) training to manage their diabetes, will participate in a “challenge” where they will be asked to allow their glucose levels to be above the normal range for up to 3 hours and below the “normal” recommended levels for up to 1 hour. A medic will be present throughout the “challenge”REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0134
Date of REC Opinion
22 Feb 2024
REC opinion
Favourable Opinion