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FLASH-UK

Recruitment for FLASH-UK is currently closed.

 

 

 

This study will determine whether glucose monitoring with the FreeStyle Libre 2 device improves blood sugar levels compared to finger prick testing in type 1 diabetes.

Project background

FLASH-UK is the first UK-based clinical trial to study the effectiveness of the FreeStyle Libre 2 device.

We will investigate whether flash glucose monitoring with the FreeStyle Libre 2 device improves blood glucose control compared to finger-prick testing in adults and adolescents with poorly controlled type 1 diabetes.

Our project aims to robustly measure clinical effectiveness, while incorporating health economics, psychosocial and user process evaluations.

For further details, read our published trial protocol (PDF, 2.5MB)

 

Project updates:

October 2021

The FLASH-UK study has reached the major milestone of Last Participant Last Visit (LPLV) from the 156 participants that were recruited to the trial.

We would like to express our utmost appreciation to sites for all of their hard work and going the extra mile during the unprecedented circumstances that all teams faced with COVID-19.

We look forward to working with sites on the closeout of the trial and look forward to sharing the findings in 2022.

April 2021

The FLASH-UK study has reached a milestone of 150 participants, with 74 randomisations in the Flash Blood Glucose Monitoring with Freestyle Libre group and 76 in the self-monitoring group.

Randomisations by site

  • Birmingham (University Hospitals Birmingham NHS Foundation Trust): 9
  • Cambridge (Cambridge University Hospitals NHS Foundation Trust): 30
  • Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 24
  • Dorset (University Hospitals Dorset NHS Foundation Trust): 13
  • Ipswich (East Suffolk and North Essex NHS Foundation Trust): 19
  • Manchester (Manchester University NHS Foundation Trust): 28
  • Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 18
  • Portsmouth (Portsmouth Hospitals NHS Trust): 9

We would like to express our utmost appreciation to sites for all of their hard work. This has enabled us to hit our recruitment target, especially when faced with the unprecedented COVID period.

We look forward to working with sites on the follow-up and retention of all participants.

February 2021

The FLASH-UK study has reached a milestone of 100 participants, with 49 randomisations in the Flash Blood Glucose Monitoring with Freestyle Libre group and 51 in the self-monitoring group.

Randomisations by site

 

  • Birmingham (University Hospitals Birmingham NHS Foundation Trust): 9
  • Cambridge (Cambridge University Hospitals NHS Foundation Trust): 23
  • Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 15
  • Dorset (University Hospitals Dorset NHS Foundation Trust): 1
  • Ipswich (East Suffolk and North Essex NHS Foundation Trust): 11
  • Manchester (Manchester University NHS Foundation Trust): 25
  • Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 7
  • Portsmouth (Portsmouth Hospitals NHS Trust): 9
December 2020

We are pleased to share a short update on the recruitment for the FLASH-UK study. We have now reached the halfway point with 82 randomisations achieved to date.

Randomisations by site

  • Birmingham (University Hospitals Birmingham NHS Foundation Trust): 3
  • Cambridge (Cambridge University Hospitals NHS Foundation Trust): 17
  • Derby (University Hospitals of Derby & Burton NHS Foundation Trust): 14
  • Ipswich (East Suffolk and North Essex NHS Foundation Trust): 11
  • Manchester (Manchester University NHS Foundation Trust): 23
  • Norwich (Norfolk & Norwich University Hospitals NHS Foundation Trust): 6
  • Portsmouth (Portsmouth Hospitals NHS Trust): 8

A huge thank you to all the participating sites for your contribution to this incredible milestone, especially with the extra difficulties during the COVID-19 pandemic.

About the FreeStyle Libre 2 device

FreeStyle Libre 2 is a glucose monitoring device in the form of a disc worn on the arm and a hand-held reader.

The device is designed to largely replace the recommended 4-10 painful finger-stick tests required each day for the self-management of type 1 diabetes. The FreeStyle Libre 2 has the additional function of optional alarms when glucose levels become low and high. Users can adjust these values within a permitted range so they are tailored to their type 1 diabetes management requirements.

Compared to the currently available Freestyle Libre system, the FreeStyle Libre 2 has the additional function of optional alarms when glucose levels become low and high.

 

Our team

Read about our research investigators

 

Information for participants

For anyone wanting to take part in our study.

Why is good control of blood sugar levels important?

Good control of blood sugar is important because it is linked to:

  • Patients experiencing fewer episodes of low (hypoglycaemia) and high (hyperglycaemia) blood sugar levels leading to fewer complications such as heart disease, kidney failure, and nerve damage.
  • Reducing the number of hospital appointments.
  • Giving patients an overall improved quality of life.

About flash glucose monitoring

A flash glucose monitor is a small sensor that you wear just under your skin. It records your sugar levels continuously throughout the day and night. You can find out your blood sugar levels by scanning the sensor using a separate reader.

Flash monitoring is less invasive than finger prick tests and can identify trends in your sugar levels to give you more confidence in your diabetes management. Read more about flash glucose monitoring on the Diabetes UK website.

Why the study is being conducted

We are investigating whether the FreeStyle Libre 2 device improves blood sugar control compared to finger-prick testing in type 1 diabetics. Evidence is required to guide future policy development on how the device could be used across NHS trusts. Without the evidence base, there is caution around providing this device to a wider group of type 1 diabetes patients. Our aim is to provide sufficient evidence to enable people with diabetes to benefit from the Freestyle Libre 2 device.

How the FreeStyle Libre 2 device works

The sensor probe (0.4mm wide and 5mm in length) is inserted into the skin. The sensor is applied to the back of the upper arm with a disposable applicator. The hand-held reader can scan through clothing and displays blood sugar level readings on the screen.

Taking part

Recruitment for FLASH-UK is currently closed to new participants.

To learn more about participating in the study in the future, read our advert for participants (PDF) and our study participant information sheet (PDF).

 

 

Information for participating sites

For hospitals involved in our study

Recruitment for the FLASH-UK study is currently closed.

Full FLASH-UK Statement on COVID-19 (October 2020)

Given the uncertainties around ongoing COVID-19 transmission and the impact this may have on access to services among those with diabetes, an approved virtual participant pathway has been integrated into the trial design.

All six original sites and one additional site are open to recruitment, with the second additional site opening to recruitment shortly.

Participants will be able to take part in the trial in a way they feel safest to do so. Participating sites will be able to offer flexibility and continued follow-up support to participants should in-clinic visits be disrupted by the COVID-19 pandemic.

Previous COVID-19 statements

July 2020

Towards the end of the inaugural annual performance review period, the COVID-19 pandemic took hold in the UK. This has had an impact on non-COVID-19 research and development across all NHS trusts. Given the risk profile of FLASH-UK and advisory notices released from participating sites and the sponsor’s trust, the Chief Investigator in discussion with Site-PIs and with the information to hand, took the decision to pause FLASH-UK to new recruits until further notice. The same was conveyed to sponsor and to the funder in the second Technical Steering Committee session which convened on the 19 March 2020.

FLASH-UK has not submitted a formal notification to halt the trial from a regulatory perspective, as the trial will aim to progress current participants by means of remote assessment or through standard of care practices that are deemed acceptable to individual trusts during the COVID-19 response. The Chief Investigator and Site Principal Investigators will review the recruitment pause on a monthly basis. A trial amendment has been approved by REC / HRA for the addition of the two new sites. These have undergone preliminary site feasibility assessment and have been confirmed as potential recruitment sites. We believe the two additional sites will place the trial in an advantageous position to ensure new site initiation and activation, can commence soonest in a post-COVID-19 transitional setting.

Hospitals participating in our study

Open sites

Manchester
Manchester University NHS Foundation Trust
Date site opened: 20 December 2019
Status: Recruitment and cohort follow-up complete.

Derby
University Hospitals of Derby & Burton NHS Foundation Trust
Date site opened: 20 December 2019
Status: Recruitment and cohort follow-up complete.

Portsmouth
Portsmouth Hospitals NHS Trust
Date site opened: 6 February 2020.
Status: Recruitment and cohort follow-up complete.

Cambridge
Cambridge University Hospitals NHS Foundation Trust
Date site opened: 27 February 2020.
Status: Recruitment and cohort follow-up complete.
Norwich
Norfolk and Norwich University Hospitals NHS Foundation Trust
Date site opened: 5 March 2020.
Status: Recruitment and cohort follow-up complete.

Birmingham
University Hospitals Birmingham NHS Foundation Trust
Date site opened: 3 March 2020.
Status: Recruitment and cohort follow-up complete.

Ipswich
East Suffolk and North Essex NHS Foundation Trust
Principal Investigator: Professor Gerry Rayman Initiation ongoing.
Date site opened: 11 September 2020
Status: Recruitment and cohort follow-up complete.

Dorset
The Adam Practice – NHS England
Principal Investigator: Dr Sarah Lumley
Date site opened: 4 November 2020
Status: Recruitment and cohort follow-up complete.

 

Contact us

Get in touch if you have any questions

Email: Flash-UK@mft.nhs.uk
Tel: 0161 276 6706 or 07792 063157
(between 9am-4pm) and ask to speak to a member of the FLASH-UK study team.

 

 

The University of Manchester