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Flash-UK

The value of flash glucose monitoring with
the FreeStyle Libre 2 system 
 

FreeStyle Libre 2 system in people with T1D delivers superior clinical benefits vs SMBG

The FLASH-UK trial demonstrated that intermittently scanned continuous glucose monitoring (isCGM) with the FreeStyle Libre 2 system produced superior clinical benefits versus self-monitoring of blood glucose (SMBG) in people with type 1 diabetes (T1D).

 

Published in the New England Journal of Medicine by Leelarathna et al, FLASH-UK was an independent, multi-centre, parallel-group randomised controlled trial (RCT).

Study objective

The FLASH-UK trial compared the efficacy of isCGM with the FreeStyle Libre 2 system versus traditional SMBG. Use of the FreeStyle Libre 2 system resulted in significantly lower glycated haemoglobin (HbA1c or A1c) levels and increased treatment satisfaction in individuals with T1D and elevated HbA1c.

Study design and study population

FLASH-UK was an open-label, parallel-group, RCT conducted at seven specialist diabetes clinics and one primary care centre in the UK. Participants were randomly assigned (1:1) to undergo isCGM with the FreeStyle Libre 2 system or to monitor their own blood glucose levels with the use of finger prick testing. Abbott played no part in the design, funding or conduct of the trial.

 Key Inclusion criteria** 

  • 16 years of age or older 
  • T1D for at least 1 year 
  • Treated either with continuous
    subcutaneous insulin infusion (CSII) or
    multiple daily injections (MDI).    
  • Baseline HbA1c of 7.5 - 11.0 %

    (9.1 - 15.5 mmol/L)

 Key exclusion criteria**

  • Use of CGM systems for more than 4 weeks
    within last 12 weeks 
  • Complete loss of hypoglycaemia
    awareness  
  • Pregnancy, planned pregnancy in the
    next 8 months or breast feeding

Primary outcome

Key secondary outcomes

Study results

Key patient baseline characteristics1 

SD: standard deviation; MDI: multiple daily injections; CSII: continuous subcutaneous insulin infusion
*The body mass index is the weight in kilograms divided by the square of the height in metres.
†Gold scores range from 1 to 7, with higher scores indicating impaired awareness of hypoglycaemia.
‡Clarke scores range from 0 to 7, with higher scores indicating impaired awareness of hypoglycaemia.

Primary and secondary outcomes

SMBG, self-monitoring of blood glucose
FSL2 : FreeStyle Libre 2 system
* Odds ratio values greater than 1 favored the intervention group. Between-group differences are expressed in percentage points.

Learn more about the reduction of HbA1c in the
FLASH-UK study

FLASH UK teaser video study HbA1c reduction P2P

A video featuring Professor Mark Evans (Co-author of the FLASH-UK study), who talks about the reduction of HbA1c in the FLASH-UK study. 

Time in Range: FreeStyle Libre 2 significantly increased Time in Range at 24 weeks1

CGM, continuous glucose monitoring; isCGM, intermittently scanned continuous glucose monitoring; SMBG, self-monitoring of blood glucose.

*Prior to group allocation, all subjects underwent blinded CGM assessment (FreeStyle Libre Pro§). At 24 weeks, those randomised to SMBG underwent a second period of blinded CGM assessment with FreeStyle Libre Pro; the data was compared to the isCGM data from the same 2-week period from the group allocated to FreeStyle Libre 2 system. 

†Adjusted Mean Difference
‡Rounded value based on actual improvement of 130 minutes (95% CI, 68 to 192) per day

Learn more about Time in Range in the
FLASH-UK study

FLASH UK teaser video TIR P2P

A video featuring Dr Emma Wilmot (Site Principal Investigator), who talks about TIR in the FLASH-UK study. 

Hypoglycaemia: FreeStyle Libre 2 system significantly decreased time spent in hypoglycaemia at 24 weeks1

*Prior to group allocation, all subjects underwent blinded CGM assessment (FreeStyle Libre Pro§). At 24 weeks, those randomised to SMBG underwent a second period of blinded CGM assessment with FreeStyle Libre Pro; the data was compared to the isCGM data from the same 2-week period from the group allocated to FreeStyle Libre 2 system.

†Adjusted Mean Difference

Learn more about the reduction of hypoglycaemia
in the FLASH-UK study

FLASH UK teaser video Hypoglycaemia P2P

A video featuring Dr Emma Wilmot (Site Principal Investigator), who talks about the reduction of hypoglycaemia in the FLASH-UK study. 

Hyperglycaemia: FreeStyle Libre 2 system significantly decreased time spent in hyperglycaemia at 24 weeks1 

*Prior to group allocation, all subjects underwent blinded CGM assessment (FreeStyle Libre Pro§). At 24 weeks, those randomised to SMBG underwent a second period of blinded CGM assessment with FreeStyle Libre Pro§; the data was compared to the isCGM data from the same 2-week period from the group allocated to FreeStyle Libre 2 system.

†Adjusted Mean Difference

‡Rounded value based on actual improvement of 86 minutes (95% CI, 13–158) per day.

FreeStyle Libre 2 system demonstrated low incidence of adverse events over 24 weeks1

The number of reported adverse events during the observation period was low and comparable across both study arms. 

FreeStyle Libre 2 system improved patient-reported outcomes.1 

Patients using the FreeStyle Libre 2 system showed high
sensor adherence

92.1% mean sensor use
during last two weeks1

11 scans/day 

on average1

Study limitations

➤ Participants were aware of the trial-group assignments. 

➤ Nearly all the participants were white. 

➤ The trial took place during the Covid-19 pandemic and some participants had virtual visits with the option of performing capillary blood tests to determine the glycated haemoglobin level at home.  

CGM: continuous glucose monitoring; TIR: Time in Range; isCGM: intermittently scanned continuous glucose monitoring 

Summary

The FLASH-UK study has proven the clinical efficacy of using the FreeStyle Libre 2 system in people
with T1D on multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)1 .


FreeStyle Libre 2 system significantly reduced HbA1c at 24 weeks, compared to SMBG


FreeStyle Libre 2 system significantly increased Time in Range


FreeStyle Libre 2 system significantly decreased time spent in hypoglycaemia


FreeStyle Libre 2 system significantly decreased time spent in hyperglycaemia


FreeStyle Libre 2 system improved patient satisfaction


Patients using the FreeStyle Libre 2 system had a high adherence to
glucose monitoring with a low incidence of sensor-related adverse events

Watch the authors summarise

the FLASH-UK study

FLASH UK study KOL video P2P MMOL

See a summary of clinical evidence supporting the use of the FreeStyle Libre 2 system here

** A comprehensive list of criteria can be found in the supplement of the publication.1
§ FreeStyle Libre Pro, no longer for sale in EU & UK.

Reference

1.Leelarathna L, Evans ML, Neupane S, et al. Intermittently scanned continuous glucose monitoring for Type 1 diabetes. N Engl J Med. 2022;387(16):1477-1487. doi:10.1056/NEJMoa2205650

2.Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the International Consensus on Time in Range. Diabetes Care. 2019;42(8):1593-1603. doi:10.2337/dci19-0028

3.Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycemic control in adults with Type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial. JAMA. 2017;317(4):371-378. doi:10.1001/jama.2016.19975

4.Lind M, Polonsky W, Hirsch IB, et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with Type 1 diabetes treated with multiple daily insulin injections: The GOLD randomized clinical trial. JAMA. 2017;317(4):379-387. doi:10.1001/jama.2016.19976

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