NEW ORLEANS, June 13, 2016 /PRNewswire/ -- Abbott (NYSE:
ABT) today announced the results of the IMPACT clinical trial,
which demonstrated that the FreeStyle® Libre system met
its primary endpoint of a reduction in time spent in hypoglycemia
(low glucose levels, defined as <70 mg/dL1) for
people with type 1 diabetes. People in the trial who used Abbott's
FreeStyle Libre sensor and reader system spent 38 percent less time
in hypoglycemia, as compared to people who managed their glucose
with traditional self-monitoring of blood glucose (SMBG) systems
(pricking a finger to draw a drop of blood that is added to a test
strip inserted into a glucose meter). Data were presented at the
American Diabetes Association's 76th Scientific
Sessions.
Data from the study also showed that the FreeStyle Libre system
reduces all measures of hypoglycemia without increasing HbA1c (an
average measurement of glucose levels in the blood over the past 90
days, typically understood to be the 'gold standard' of measuring
overall glucose control) versus SMBG, showing that the FreeStyle
Libre system can safely and successfully replace the need for
routine finger sticks2 as a tool for managing
diabetes.
Traditional self-monitoring of blood glucose among people with
both type 1 and type 2 diabetes falls short of U.S., E.U. and other
key guidelines that recommend at least 4-8 self-tests per
day3, with the consensus that the more testing per day,
the better people have an understanding of their glucose levels and
can manage their diabetes accordingly. In actuality, data shows
that people test less than three times per day4—the
biggest obstacle being the pain and hassle of routine finger
sticks5. But when people with diabetes don't monitor
their glucose levels regularly, additional complications including
hypoglycemia can become life-threatening.
"Hypoglycemia is the main barrier to attaining optimum
glucose control in persons with insulin-treated diabetes. Moreover,
hypoglycemic events can not only lead to adverse clinical outcomes
including cardiovascular events and death, but they can also incur
significant emergency healthcare costs," said Prof.
Jan Bolinder, MD, FRCPE,
Karolinska Institutet, Stockholm, Sweden, and chief investigator
for the IMPACT study. "This clinical trial has proven that patients
will test more often when they have an easier and more
convenient way to do so utilizing a device like FreeStyle
Libre, leading them to ultimately being healthier, which is our
goal for our patients."
Empowering patients with data
For the first 14
days of the IMPACT study, the participants wore a FreeStyle Libre
sensor but did not have access to their glucose results. During the
next period6, when participants had access to their data
via the FreeStyle Libre reader, time spent in
hypoglycemia7 was reduced by 33 percent within two weeks
and was sustained by at least this amount (between 33 percent and
42 percent) throughout the study. Time in range (70-180 mg/dL) was
increased by one hour per day versus SMBG.
Data from the trial also showed a significant increase in
testing frequency with participants scanning their FreeStyle Libre
sensors an average of 15 times per day. More scanning led to more
access to information about glucose levels, which ultimately led to
FreeStyle Libre users being able to take action to significantly
reduce their hypoglycemia and hyperglycemia on their own.
"The IMPACT trial confirms the importance of empowering people
with the data they need to make their own choices," said
Jared Watkin, senior vice president,
Diabetes Care, Abbott. "We cannot underestimate the power of
knowledge—especially for someone who is managing a chronic
condition. Our goal is to help our customers be healthier and
live fuller lives, and it's clear from this trial that FreeStyle
Libre provides our customers just what they need to do that."
Hypoglycemia and HbA1c
The FreeStyle
Libre system has shown that it reduces time spent in hypoglycemia
by 38 percent while also significantly reducing nocturnal
hypoglycemia (<70 mg/dL; between the
hours of 11 p.m. and 6 a.m.) by 40 percent. In addition,
serious hypoglycemia (<55 mg/dL) was reduced by 50 percent.
Throughout the study, results showed FreeStyle Libre users
significantly reduced time spent in hypoglycemia without increasing
HbA1c, showing that more frequent testing and a complete glycemic
profile enables better diabetes management.
Conventional wisdom in diabetes care is that reductions in HbA1c
are linked with increasing risk of
hypoglycemia8—traditionally, there is an inverse
relationship between risk of severe hypoglycemia (low glucose
levels) and HbA1c reduction (an average number). But in this
clinical trial, subjects managed to significantly lower their time
spent in hypoglycemia without an increase in their HbA1c levels,
shifting a paradigm in the understanding of diabetes treatment and
management. In addition, those reductions were achieved rapidly
with the first unmasked sensor from the start of the trial and were
sustained over the six months of the study through continued use of
the FreeStyle Libre system.
About the study
The IMPACT clinical trial is a
randomized, controlled six-month trial to evaluate the
effectiveness of the FreeStyle Libre system in improving glycemic
control for the self-management of type 1 diabetes as compared to
self-monitoring of blood glucose (SMBG). The primary endpoint was a
difference in number of hours per day in hypoglycemia (<70
mg/dl) between the group using the FreeStyle Libre system and the
group using traditional finger sticks (SMBG) from days 194-208. Two
hundred and fifty-two (252) patients over the age of 18
participated in the trial, which took place across 23 sites in
Austria, the Netherlands, Spain, Sweden
and Germany.
Key findings from the trial include (FreeStyle Libre users
versus traditional SMBG):
- 38 percent reduction in time spent in hypoglycemia (<70
mg/dl)
- 40 percent reduction in time spent in nocturnal hypoglycemia at
night (11 p.m. to 6 a.m.)
- 50 percent reduction in serious hypoglycemia (<55
mg/dl)
- No increase in HbA1c at six months
- Glucose monitoring increased to an average of 15 scans per
day
- Routine finger sticks2 were nearly
eliminated—reduced by 91 percent
About the FreeStyle Libre System
Abbott′s
FreeStyle Libre system consists of a small, round
sensor—approximately the size of two stacked quarters—worn on the
back of the upper arm for up to 14 days, which measures glucose
every minute in interstitial fluid through a small (5mm long, 0.4mm
wide) filament that is inserted just under the skin and held in
place with a small adhesive pad. A reader is scanned over the
sensor to get a glucose result painlessly9 in less than
one second. Each scan displays a real-time glucose result, an eight
hour historical trend and the direction the glucose is heading.
Unlike other continuous glucose monitoring devices (those that
measure glucose levels in real-time throughout the day and night),
the FreeStyle Libre system is factory calibrated—meaning that it
does not require a finger stick test for calibration, where other
continuous glucose monitoring systems might require two or more
calibrations per day.
In 2014, Abbott launched the FreeStyle Libre system in
France, Germany, Italy, the
Netherlands, Spain,
Sweden and U.K. It is now
available in 11 countries in Europe, and recently launched in Australia and Brazil. A professional-use version called
FreeStyle Libre Pro utilizes similar technology and is available in
India and South Africa.
About Abbott
Abbott is a global healthcare
company devoted to improving life through the development of
products and technologies that span the breadth of healthcare. With
a portfolio of leading, science-based offerings in diagnostics,
medical devices, nutritional and branded generic pharmaceuticals,
Abbott serves people in more than 150 countries and employs
approximately 74,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at
@AbbottNews.
1ADA (American Diabetes Association), CDA (Canadian
Diabetes Association) and EMA (European Medicines
Agency)
2 A finger prick test using a blood glucose meter is
required during times of rapidly changing glucose levels when
interstitial fluid glucose levels may not accurately reflect blood
glucose levels or if hypoglycaemia or impending hypoglycaemia is
reported by the system or when symptoms do not match the system
readings.
3 Schnell O, Alwai H, Battelino T, et al. Consensus
statement on self-monitoring of blood glucose in diabetes. A
European perspective. Diabetes, Stoffwechsel und Herz, Band
18, 4/2009:3-7
4 Vincze G, Barner JC, Lopez D. Factors associated with
adherence to self-monitoring of blood glucose among persons with
diabetes. Diabetes Educ.
2004;301(1);112-125.
5 Wagner J, Malachoff C, Abbott G. Invasiveness as a
barrier to self-monitoring of blood glucose in diabetes.
Diabetes Technolo Ther. 2005; 7(4):612-619.
6 Nominally two weeks between days 15 and 31
7 Time <70mg/dL
8 The effect of intensive treatment of diabetes on the
development and progression of long-term complications in
insulin-dependent diabetes mellitus. The Diabetes Control and
Complications Trial Research Group. N Engl J Med.
1993;329(14):977-86.
9 Based on a user study, 100% of patients agree that
there is no pain when they check their glucose readings by scanning
the FreeStyle Libre sensor.
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