- Randomized clinical trial of Abbott's FreeStyle Libre 2 system
compared to self-monitoring of blood glucose (SMBG) shows FreeStyle
Libre 2 leads to significant reductions in glycated hemoglobin
(HbA1c) levels at 24 weeks in people with Type 1 diabetes and
sub-optimal glycemic control1
- People using the FreeStyle Libre technology had average HbA1c
levels a significant 0.5% lower than those using SMBG at the end of
the study period1
- The FreeStyle Libre 2 system use was also linked to
improvements in overall satisfaction and reduced burden associated
with glucose monitoring1
PARK, Ill., Oct. 6, 2022
/PRNewswire/ -- A new study published in The New England Journal of
Medicine finds that for adults with Type 1 diabetes and
sub-optimal glycemic control, Abbott's FreeStyle Libre®
2 glucose monitoring system provided significant reductions in
glycated hemoglobin (HbA1c) compared to self-monitoring of blood
glucose (SMBG), which were sustained for the study duration of 24
weeks.1 Use of the FreeStyle Libre 2 system was also linked to
improvements in participant-reported quality of life outcomes,
including overall satisfaction and reduction in burden associated
with glucose monitoring.
After six months, people who used the FreeStyle Libre 2 system
reduced their HbA1c levels by an average of 0.8% (8.7% to
7.9%).1 Lowering HbA1c by this amount can decrease the
risk of developing diabetes complication in the future. In
comparison, people using SMBG reduced their HbA1c levels by an
average of only 0.2% (8.5% to 8.3%).1
HbA1c provides an estimate of average glucose levels over the
preceding three months and is the standard measurement of glycemic
control for people with diabetes.2 Increased HbA1c is
associated with a greater risk of developing complications related
to diabetes, such as cardiovascular disease, kidney disease and eye
"Continuous glucose monitoring has been a critical tool for
people living with diabetes, both to avoid painful fingersticks and
to help manage glucose levels," said study author Dr. Lalantha
Leelarathna from the University of Manchester NHS Foundation Trust.
"This data adds to the growing body of evidence that demonstrates
the technology helps bring HbA1c levels closer to the target range,
which ultimately decreases risks of further complications."
The trial included 156 people aged 16 years or older with Type 1
diabetes and HbA1c levels of 7.5% to 11%, none of whom had
previously used continuous glucose sensing technology. For 24
weeks, half the participants were randomized to monitor their
glucose with the FreeStyle Libre 2 system and the other half with
The average HbA1c level of participants using the FreeStyle
Libre 2 system was 0.3% lower at 12 weeks and 0.5% lower at 24
weeks, statistically significant compared to those using SMBG.
FreeStyle Libre users also had a greater likelihood of reducing
their HbA1c by a full percentage point by the end of the study
period. They spent an additional 130 minutes per day with glucose
levels in the target range (70-180 mg/dL) and 43 minutes per day
less time with dangerously low glucose levels (<70 mg/dL).
FreeStyle Libre 2 users also reported a positive impact on
quality of life, captured by participant-reported answers to the
Diabetes Treatment Satisfaction Questionnaire and the Glucose
Monitoring Satisfaction Survey. At 24 weeks, these participants
reported greater overall treatment satisfaction and reduced burden
associated with glucose monitoring.
"This randomized study clearly illustrates the importance of
continuous glucose monitoring for adults with Type 1 diabetes,"
said Dr. Mahmood Kazemi, chief
medical officer for Abbott's diabetes care business. "This
clinically-significant change in HbA1c levels shows FreeStyle Libre
technology empowers people to make lifestyle decisions that improve
their glucose control and, ultimately, may result in a reduction in
diabetes-related health problems down the line."
The study is part of FLASH-UK, the first randomized clinical
trial of the FreeStyle Libre 2 system compared to SMBG. It was led
by a team at The University of Manchester together with investigators from
eight centers in the United
Cambridge, Derby, Dorset, Ipswich, Manchester, Norwich and Portsmouth) and funded by Diabetes UK. Abbott
was not involved in the execution or funding of the study.
Abbott's FreeStyle Libre systems include a sensor, which is
applied to the back of the upper arm for up to 14 days and
continuously measures glucose, paired with a compatible smartphone
app4 or reader that display glucose readings. The
FreeStyle Libre portfolio is the number one sensor-based glucose
monitoring system in the world5, having changed the
lives of more than 4 million people across more than 60
countries6 by providing breakthrough technology that is
accessible and affordable.7
Abbott (NYSE: ABT) is a global healthcare leader that helps
people live more fully at all stages of life. Our portfolio of
life-changing technologies spans the spectrum of healthcare, with
leading businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on
Indications and Important Safety
FreeStyle Libre 2 system: Failure to use FreeStyle Libre
2 system as instructed in labeling may result in missing a severe
low or high glucose event and/or making a treatment decision,
resulting in injury. If glucose alarms and readings do not match
symptoms or expectations, use a fingerstick value from a blood
glucose meter for treatment decisions. Seek medical attention when
appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us
for safety info.
1 Leelarathna L, Evans M, Neupane S, et al. (2022)
Intermittently Scanned Continuous Glucose Monitoring for Type 1
Diabetes. New England Journal of Medicine, Oct. 5, DOI: 10.1056/NEJMoa2205650
2 World Health Organization. Use of Glycated Hemoglobin
(HbA1C) in the Diagnosis of Diabetes Mellitus: Abbreviated Report
of a WHO Consultation Published. 2011. p. 2, Glycated hemoglobin
(HbA1c) for the diagnosis of diabetes. Available online at:
Last accessed April 2022.
3 Sherwani SI, Khan HA, Ekhzaimy, et al. Significance of
HbA1c Test in Diagnosis and Prognosis of Diabetic Patients.
Biomarker Insights 2016:11 95–104 doi: 10.4137/BMI.S38440
4 The app is only compatible with certain mobile
devices and operating systems. Please check our website for more
information about device compatibility before using the
5 Data on file, Abbott Diabetes Care. Data based
on the number of users worldwide for the FreeStyle Libre portfolio
compared to the number of users for other leading personal use,
sensor-based glucose monitoring systems.
6 Data on file. Abbott Diabetes Care.
7 Based on a comparison of list prices of the
FreeStyle Libre portfolio versus competitor CGM systems available
worldwide. The actual cost to patients may or may not be lower than
other CGM systems, depending on local reimbursement, if any.
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