FreeStyle Libre Flash Glucose
Monitoring System FAQs
Do I need a separate blood glucose meter when using the FreeStyle Libre system?
No. For convenience, there is a built-in FreeStyle Optium blood glucose and ketone meter within
the reader that can be used for blood glucose and ketone readings.
Can I perform a blood ketone test with the FreeStyle Libre system?
You can use the built-in meter to check your blood ketone levels using FreeStyle Optium b-
ketone test strips. You should perform a blood ketone test on your fingertip only. Be sure to read
the test strip instructions for use prior to using the built-in meter.
What is a Flash Glucose Monitoring System?
Flash glucose monitoring is a new, user-friendly way to discreetly obtain glucose readings. A
flash glucose monitoring system provides a complete picture showing the current glucose
reading plus you can see how glucose levels are changing in a flash by just scanning the reader
over the sensor.
What makes flash glucose monitoring system unique is that a quick scan of the reader over the
sensor provides a complete picture of your glucose including the current glucose reading, 8 hour
history and trend arrow showing if your glucose level is going up, down or staying steady.
What is the FreeStyle Libre flash glucose monitoring system?
The FreeStyle Libre flash glucose monitoring system is the first product in the flash glucose
monitoring category and is designed to liberate people with diabetes from many of the hassles of
glucose monitoring, such as routine finger pricking.
The FreeStyle Libre system contains two components:
FreeStyle Libre sensor: A small, disposable 14-day sensor that is worn on the back of the upper
arm and automatically measures glucose levels and stores them for a period of 8 hours. Every
time the user scans the reader over the sensor, the glucose data from sensor is transferred to
the reader in 1 second.
FreeStyle Libre reader: A compact, handheld reader that displays glucose readings and stores
up to 90 days of glucose data. When the reader is scanned over the sensor, it shows a current
glucose reading, last 8-hours of data as well as a trend arrow (indicating if glucose is going up,
down or staying steady). To obtain a glucose reading, simply perform a quick, 1-second scan of
the reader over the sensor. This easy scan gives you more information than blood glucose
monitoring without the need for routine finger pricks1.
1 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.
What does 'Flash' mean?
'Flash' reflects the fact that users can obtain glucose readings quickly by just scanning the reader
over the sensor. Flash glucose monitoring also provides a flash of insight to people with diabetes
and their healthcare professionals.
How does the FreeStyle Libre system work?
To obtain a glucose reading, simply perform a quick 1-second scan of the reader over the
sensor.
This easy scan gives you more information than a blood glucose test without the need for routine
finger pricks1. The FreeStyle Libre system also offers software to generate concise reports that
provide a clear analysis of your glucose data.
1 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.
Does the FreeStyle Libre system need to be calibrated?
No, the FreeStyle Libre sensor is calibrated during the manufacturing process so you don't have
to. The sensor is activated by scanning and then, after a 1 hour warm up period, it starts to
record glucose readings automatically.
Is FreeStyle Libre accurate?
The FreeStyle Libre system is clinically proven to be accurate, stable and consistent over 14
days compared to blood glucose testing without the need for finger prick calibration
In a clinical study, the FreeStyle Libre system achieved 11.4% Mean Absolute Relative
Difference (MARD) compared to blood glucose testing2
99.7% of glucose results fall within Zone A and Zone B of the Consensus Error Grid, when
compared against blood glucose testing
2
The measurement errors associated with these zones have no effect on clinical action and little
or no effect on clinical outcomes3
2 Bailey, T, et al. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technology and
Therapeutics v17 n11 July 2015 (10.1089/dia.2014.0378)
3 Parkes J, Slatin S, Pardo S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement
of blood glucose. Diabetes Care. 2000;23(8):1143-1148.
Is interstitial fluid an adequate replacement to blood glucose testing?
Interstitial fluid-based glucose readings are a reliable indicator of blood glucose levels4
The physiological lag in ISF glucose, with respect to changes in blood glucose, is about 5-10
minutes4
The average lag time of the FreeStyle Libre system is approximately 5 minutes, which is unlikely
to impact routine day-to-day treatment decisions3, 4
3 Parkes J, Slatin S, Pardo S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement
of blood glucose. Diabetes Care. 2000;23(8):1143-1148.
4 Rebrin K, Sheppard NF Jr, Steil GM. Use of subcutaneous interstitial fluid glucose to estimate blood glucose: revisiting delay and
sensor offset. J Diabetes Sci Technol. 2010;4(5):1087-1098.
How is Flash Glucose Monitoring different to Blood Glucose Monitoring (BGM)?
Traditional blood glucose monitoring provides users with glucose readings that represent distinct
points in time. Users do not get information regarding how their glucose levels have been
changing, nor do they get information about where their glucose levels are heading. Without such
information, it can be easy to miss significant glucose fluctuations - the ups and downs. The
FreeStyle Libre system is a new way to obtain glucose readings. It allows the user to get their
current glucose reading by just scanning the reader over the sensor, and also provides a
complete picture of glucose variations.
Can the FreeStyle Libre system be used by children?
FreeStyle Libre is currently indicated for use by adults (18 years and over) diagnosed with insulin
dependent diabetes. In New Zealand, the product has not been assessed for use in children
under 18 years and Gestational Diabetes Mellitus. Please consult your Healthcare Professional
on whether this product is right for you.
Can the FreeStyle Libre system calculate a mealtime insulin dose?
Yes, the system can calculate a suggested mealtime insulin dose when using the built-in blood
glucose meter since it has a built-in insulin dose calculator function.
Please note that this feature only works when using the blood glucose test strip port and needs
to be activated by a healthcare professional.
How does the FreeStyle Libre system calculate an insulin dose?
The insulin calculator utilises settings entered into the insulin calculator during one of two setup
modes (Easy or Advanced); this feature requires an understanding of the use of insulin and must
be set up by a healthcare professional. Using the settings they enter, the glucose reading from
the built-in blood glucose meter and carbohydrate information (in grams or servings) the user
provides, the insulin calculator software in the reader calculates a suggested insulin dose.
Does the insulin calculator work with any type of insulin?
No, the insulin calculator can assist you with calculating rapid-acting (meal-time or short-acting)
insulin doses only. The insulin calculator must be set up by a healthcare professional.
What's the difference between the Easy and Advanced setup for insulin calculator?
'Easy setup' is for users who use a fixed dose of rapid-acting insulin before meals. 'Advanced
setup' is for users who count carbohydrates (in grams or servings) and/or use a correction factor
to adjust doses of rapid-acting insulin at meals. The insulin calculator must be set up by a
healthcare professional.
How do you discard the disposable components, for example sensor pack and
applicator?
This product should be disposed of in accordance with all applicable local regulations related to
the disposal of electronic equipment, batteries, sharps, and materials potentially exposed to body
fluids.
This means the used applicator and sensor pack should be disposed of in a Biohazard Sharps
bin - Clinical waste referral is required from the district nurse or GP, but the majority of people
with diabetes will already have the necessary arrangements in place.
How should the FreeStyle Libre system be stored?
Both the reader and the sensor should be stored between 4 and 25°C.
What is a Trend Arrow? How does it work? And what does it tell me?
The FreeStyle Libre Flash Glucose Monitoring System offers a Trend Arrow with each glucose
reading which tells you which way and how quickly glucose levels are changing. So, at any given
time, you not only know what your glucose level is currently, but also which way it is heading.
Depending on the direction of Trend Arrow, you can find out if your glucose levels are going up,
down or staying steady, facilitating better decision-making.
Why does the system require a 1 hour warm up period?
Abbott Diabetes Care is committed to making its products safe for the user. After the insertion,
the sensor and the body need to equilibrate (or settle). We have found through our research that
it is not always easy to accurately measure glucose in the body until this equilibration happens.
Therefore, we let the system equilibrate for 1 hour to make sure that it is providing accurate
glucose readings.
Can my healthcare professional access my reports remotely e.g. over the internet or
cloud?
No, the reports are available only when the reader is connected to a computer. However, you
can send the pdf version of your reports to your healthcare professional via e-mail (with your
healthcare professional's permission).