FLASH - Flash glucose monitoring in children with diabetes
Research type
Research Study
Full title
Implementation of flash glucose monitoring in four paediatric diabetes clinics – before and after study to produce real world evidence of patient benefit
IRAS ID
286988
Contact name
Rebecca Kandiyali
Contact email
Sponsor organisation
Head of Research Governane
Clinicaltrials.gov Identifier
2020-3264 , Research Enterprise Development Case number (University of Bristol)
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Research Summary
Type 1 diabetes is the most common form of diabetes in children and occurs when the body does not produce insulin. People with type I diabetes need to inject insulin and monitor the levels of sugar in their blood.
For many young people monitoring blood sugar levels means frequent painful finger prick blood tests. We want to find out if a new sensor, worn on the upper arm, to monitor sugar levels works better. This is called ‘flash monitoring’ and there is only one type of flash monitoring device called Freestyle Libre (Libre) currently available on the NHS. Libre is the size of a £2 coin and has a tiny fine wire which senses the sugar levels in the fluid surrounding skin cells. A hand-held reader or Smartphone can be waved above the sensor to get an instant ‘flash’ reading. This tells the young person/their parent if the sugar level is safe. All the readings from Libre can be sent to a computer and used to guide treatment decisions in clinics.
We want to compare Libre with finger prick testing to see if it improves long-term blood sugar control and reduces hospital admissions in children. To do this we will use information collected from children’s diabetes clinic appointments 12 months before and 12 months after starting Libre. We also want to find out what young people and parents, doctors and nurses think about Libre through interviews and focus groups. We will also observe clinician activity too assess the impact of Libre on workload. We will see if it offers value for money to the NHS. This study will focus on four diabetes services in the South West: Bristol, Plymouth, Exeter and Swindon.
Summary of Results
Type 1 diabetes is the most common form of diabetes in children and occurs when the body does not produce insulin. People with type 1 diabetes need to inject insulin and monitor the levels of sugar in their blood. Keeping blood sugar within a healthy range is important to stay well. For many young people, monitoring blood sugar levels means frequent painful finger prick blood tests. We wanted to find out if a new sensor, worn on the upper arm, to monitor sugar levels works better. This is called ‘flash monitoring’. There is only one type of flash monitoring device called Freestyle Libre (Libre) currently available on the NHS. Libre is the size of a £2 coin and has a tiny fine wire which senses the sugar levels in the fluid surrounding skin cells. A hand-held reader or Smartphone can be waved above the sensor to get an instant ‘flash’reading. This reading shows if the sugar level is safe. All the readings from Libre are sent to a computer and used to guide treatment decisions in clinics.
We compared Libre with finger prick testing to see if it improves long-term blood sugar control and reduces hospital admissions in children. To do this we used information collected from children’s diabetes clinic appointments one year before and after starting Libre. We also found out what young people and parents, doctors and nurses thought about Libre. We looked to see if it offers value for money to the NHS. Libre may help young people improve their long-term blood sugar control, but doctors think the difference is too small to matter. Young people told us Libre made life easier. Libre was more costly compared to finger prick testing. We jointly produced YouTube animations with our young people involvement group.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0195
Date of REC Opinion
29 Sep 2021
REC opinion
Further Information Favourable Opinion