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FREQUENTLY ASKED QUESTIONS ABOUT THE ABBOTT LIBRE SENSE GLUCOSE SPORT BIOSENSOR

What is the Abbott Libre Sense Glucose Sport Biosensor?

The Abbott Libre Sense Glucose Sport Biosensor (‘biosensor’) is designed for glucose sport use only and offers streaming glucose data with a dynamic range of 55 – 200 mg/dL for performance athletes to monitor their glucose levels. It is specifically designed for sports use. The biosensor is not for medical use and is not intended for the diagnosis, treatment, or management of disease.

Through non-exclusive partnerships, Abbott plans to make the biosensor compatible with sport companies’ mobile apps and products which will provide glucose levels, trends and metrics to provide insights to support optimal fueling strategy and performance for athletes.

What benefit will the biosensor provide to athletes?

The biosensor, when used with a compatible partner app, is designed to provide a glucose monitoring experience that will enable athletes to understand the efficacy of their nutrition choices during training and competition. It will therefore inform athletes about how to fuel appropriately, to fill their glycogen stores prior to a race and to know when to replenish during a race to maintain athletic performance.1,2

1 Moore, D. 2015. Nutrition to Support Recovery from Endurance Exercise: Optimal Carbohydrate and Protein Replacement. American College of Sports Medicine. 14(4), pp. 294-300.

2 Olsson, J. 2016. Swedish School of Sport and Health Sciences, GIH, Department of Sport and Health Sciences. Swedish Elite Swimmers Blood Glucose Levels During Recovery: A Descriptive Study Using Continuous Glucose Monitoring Systems.

How does a user obtain glucose readings from the biosensor?

To obtain glucose readings, users simply start a biosensor with a quick scan of the smartphone over the biosensor. After a 1-hour warm up period, users will start to automatically receive streaming glucose data every minute on their compatible smartphone app.

What products are compatible with the biosensor?

We have partnered with Supersapiens to display and translate glucose readings from our biosensor into fueling strategies for athletes. Learn more at www.Supersapiens.com.

What components are included in the biosensor pack?

The biosensor pack contains the biosensor and an applicator to prepare the biosensor for use. The biosensor is applied to the back of the upper arm with the aid of the biosensor applicator.

How frequently does the biosensor capture and store glucose readings?

The biosensor automatically reports the glucose concentration in the interstitial fluid every minute. It also automatically records the glucose concentration every 15 minutes, storing that data in a rolling 8-hour log. If the biosensor is scanned with the compatible partner app at least 3 times per day, so as to download the data from the biosensor to the phone before the end of 8 hours, no data will be lost. If the biosensor is scanned after the 8-hour limit has passed, the oldest data will be lost. That means, the biosensor will only keep the latest 8 hours of data collected.

Can the biosensor be used with children?

The biosensor is intended to be used by athletes who are 16 years and older.

Where can I purchase the product?

Product will be available through our partner web shops in select markets in Europe at www.supersapiens.com

How can athletes benefit from visibility to their glucose data?

Proper nutrition at the right intervals allows athletes to maintain a stable glucose level during endurance activities, which is important for managing overall energy and avoiding muscle fatigue. A study published in the American College of Sports Medicine showed that an athlete who understands the effects of their nutritional intake will have a better chance at improving their performance during exercise.1 In addition, research has shown that understanding real-time glucose levels can guide nutritional intake to help improve muscle recovery and athletic performance.2

Which athletes will benefit most from the data provided by the Abbott Libre Sense Glucose Sport Biosensor?

Athletes who perform high intensity exercise or exercise with a duration of more than 90 minutes, e.g. in endurance cycling, running or triathlons, are most likely to see benefits from managing their fuelling strategies with regards to carbohydrate loading. Visibility to their glucose levels can help them understand the efficacy of their nutrition choices, fuel appropriately, avoid fatigue from low glucose events, and know when to replenish during training and competition.

How is the biosensor applied to the body?

The biosensor is applied to the back of the upper arm with a simple, disposable device called an applicator. When the biosensor is applied, a small (5 mm) filament is inserted just under the skin and held in place with a small adhesive pad.

Does it hurt to apply the biosensor?

Most users don’t feel pain when applying the biosensor.

In a study conducted by Abbott, 91.6% of users surveyed (n=119) agree that it was painless to apply the sensor. Data on file, Abbott.

Will the user feel the biosensor while wearing it?

The portion of the biosensor that gets inserted under the skin is less than 0.4mm wide (1mm is about the thickness of a few strands of human hair) and it’s inserted only about 5mm under the skin.

In a study conducted by Abbott, 91.6% of users surveyed (n=119) agree that it was painless to apply the sensor. Data on file, Abbott.

When applying the biosensor to my arm, do I need to stretch or pinch the skin?

No. Users should only apply the biosensor to the back of their upper arm. Wash the site using a plain soap and water, let it dry completely, and then clean with an alcohol wipe. Allow the site to air dry. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.

What if I have a hairy arm and have trouble applying the biosensor?

The site selected on the back of the upper arm should be clean-shaven.

Can the biosensor be applied to tattooed skin?

Yes. There is no interaction expected between tattoo ink and the biosensor. It is advised to avoid areas with scars, moles, stretch marks or lumps when applying the biosensor.

Will I bleed when the biosensor is inserted?

Based on a study of 146 participants, the following incidence of skin issues were observed*. Four occurrences of erythema (superficial reddening of the skin) were reported to be moderate in intensity. All other skin issues were reported to be mild in intensity.

  • Bleeding – 0.7% of the time
  • Bruising – 0.7% of the time
  • Erythema – 2.7% of the time
  • Pain – 0.7% of the time
  • Scabbing – 2.7% of the time

*Data on file. Abbott, Inc.

Should the biosensor be removed if there is bleeding?

If there is bleeding that does not stop, remove the biosensor, and apply a new one at a different site.

What if I get a rash or infection from the biosensor?

Some individuals may be sensitive to the adhesive that keeps the biosensor attached to the skin. If you notice significant skin irritation around or under your biosensor, remove the biosensor and stop using the biosensor. Contact your health care professional before continuing to use the biosensor.

How do you remove the biosensor?

Pull up the edge of the adhesive that keeps your biosensor attached to your skin. Slowly peel the biosensor away from your skin in one motion. Note: Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol.

How long can the biosensor be worn?

The disposable glucose biosensor is designed to adhere to the back of the upper arm and provide accurate glucose readings for up to 14 days.

Why does it take up to an hour to get my first reading?

The biosensor is clinically proven to be accurate, stable and consistent for up to 14 days. Soon after the insertion of a biosensor, there are physiological processes that happen as the biosensor and the body equilibrate. These processes are part of the body's natural response to the biosensor insertion. The equilibration process can vary from one person to another and may not always happen in the same manner for any one person. Therefore, we have decided to let the biosensor equilibrate for 1 hour to ensure that the system is providing accurate glucose readings.

Can you wear the biosensor while in a tanning bed or a sauna?

We have not conducted studies with the biosensor in tanning beds or saunas. Please consider that the biosensor’s operating temperature range is 10°C to 45°C (50°F to 113°F). Additionally, excess sweating may loosen the adhesive.

Can I wear the biosensor for winter events (e.g. skiing)?

The biosensor may be used during winter activities. Please consider that the biosensor’s operating temperature range is 10°C to 45°C (50°F to 113°F). Additionally, excess sweating may loosen the adhesive.

Is the biosensor water proof?

The biosensor can be worn while bathing, showering, swimming or exercise. The biosensor has been tested to with stand immersion in up to one metre (3 ft) of water for up to 30 minutes.

Can an over-bandage be used with the biosensor?

Medical grade adhesive bandage or tape can be used. When using an over-bandage, it must be applied at the time of the biosensor application. The opening/hole in the centre of the biosensor must not be covered.  Additional bandages/tape can be applied but do not remove bandages/tape once applied until the biosensor is ready for removal.

Do users have to remove the biosensor during an MRI/CT scan/Diathermy?

If the user has a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X-ray, MRI (Magnetic Resonance Imaging), or CT (Computed Tomography) scan, or high frequency electrical heat (diathermy) treatment, they need to remove the biosensor they are wearing and apply a new biosensor after the appointment. The effect of these types of procedures on the performance of the system has not been evaluated.

What if the user needs to remove the biosensor before within 14 days (or if it falls off)?

A biosensor that has been removed or that has fallen off cannot be reused. Users should replace the biosensor and start a new biosensor. The compatible partner app will identify that it is a new biosensor and ask users if they want to start it.

Can I re-use the biosensor?

No, do not reuse biosensors. The biosensor has been designed so that it cannot be reused. It is also not suitable for re-sterilisation.

Do I have to use the biosensor for 14 consecutive days? 

Once activated, the the biosensor may be worn for up to 14 consecutive days. You may remove the biosensor before the end of those 14 days; however, you cannot re-use the same biosensor once removed.

What happens if the biosensor is worn beyond 14 days? 

After 14 days of wear, the user is notified that the biosensor has ended. The biosensor automatically stops collecting glucose data and should be removed 14 days after being started. The biosensor should be replaced with a new biosensor.

Does this biosensor require any special handling at the airport?

The biosensor can be exposed to common electrostatic discharge (ESD) and electromagnetic interference (EMI), including airport metal detectors and body scanners. You can keep your biosensor on while going through these. However, the biosensor should not be exposed to some airport scanners (i.e. x-ray and millimetere radio-wave). If in doubt about the type of security scan your biosensor is passing through, notify the Security Officer prior to proceeding through the airport security checkpoint and request another type of screening to be performed by the Security Officer.

What if the biosensor is packed in luggage? What about the scanners that luggage goes through either checked or carry on?

The biosensor can be exposed to common electrostatic discharge (ESD) and electromagnetic interference (EMI), including airport metal detectors and body scanners. The biosensor can safely go through these when packed in luggage, including hand luggage/carry-on or security tray. However, the biosensor should not be exposed to some airport scanners (i.e. x-ray and millimetre radio-wave). If in doubt about the type of security scan your biosensor is passing through, notify the Security Officer prior to proceeding through the airport security checkpoint and request another type of screening to be performed by the Security Officer.

Can the biosensor be used during a flight?

We recommend that you follow flight regulations. Aviation regulations dictate that a flight crew may decide that they do not want any electronic devices powered on during a flight, in which case, power off your smartphone during the flight and do not use it for scanning the biosensor. In general, however, the biosensor is not restricted by flight regulations and can be used on planes.

I’m travelling – can I get a biosensor from a different country? Will it work with my compatible partner app?

Biosensors purchased in one market may not be compatible with mobile apps and compatible partner apps in other markets. If you are travelling, it is advisable to ensure that you take enough biosensors with you to last the duration of your trip.

How big is the biosensor?

The biosensor is 5 mm in height and 35 mm in diameter, or about the size of 2 Euro coin.

Has the biosensor been tested in (a) water and (b) sea water?

a. The biosensor was tested to IP27 standards and can be used while swimming, in up to 1 metre of water for up to 30 minutes.

b. The biosensor has not been tested in seawater. There is no reason to expect that performance in seawater would be different from fresh water as the salinity would not affect the ability of water to get in to the biosensor.

Can the biosensor be used at altitudes > 3,048 metres (10,000 feet)?

Biosensor performance has been tested to 3,048 metres (10,000 feet) only. It has not been evaluated for use in altitudes >3,048 metres (10,000 feet).

What type of NFC tag is used for the biosensor?

The biosensor is based on ISO15693.

What type of Bluetooth is used for the biosensor?

The Biosensor Bluetooth Radio Frequency is 2.402–2.480 GHz BLE; modulation is GFSK; and maximum power output is 0 dBm EIRP.

What is the operating and storage altitude?

The operating and storage altitude is -381 metres (-1,250 feet) to 3,048 metres (10,000 feet).

What kind of battery is in the biosensor?

The battery in the biosensor is a silver oxide non-removable battery.

How do users discard the disposable components, for example the biosensor pack and applicator?

Regulations vary depending on location. 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.

“Sharps" include any device or object used to puncture or lacerate the skin. Biosensors are not classed as sharps as the sharp is left in the applicator.

What kind of cleaning or disinfection procedure is required to use the biosensor?

The biosensor is intended for single-use and does not require cleaning and disinfection.

Can people with diabetes use the Abbott Libre Sense Glucose Sport Biosensor?

The Abbott Libre Sense Glucose Sport Biosensor is indicated for sports use only. The biosensor measures glucose between 55 and 200 mg/dL for athletic use. It is NOT intended for use in diagnosis, treatment, or management of diabetes or any other disease.

Will my glucose data tell me if I’m pre-diabetic or diabetic?

No, the biosensor is not intended for use in the diagnosis, treatment, or monitoring of disease. For concerns regarding pre-diabetes or diabetes, consult your healthcare professional.

Is the biosensor compatible with any diabetes apps or readers?

No, the biosensor is not compatible with any diabetes apps or readers. The biosensor is not intended for use in the diagnosis, treatment, or monitoring of disease.

1. Moore, D. 2015 .  Nutrition to Support Recovery from Endurance Exercise: Optimal Carbohydrate and Protein Replacement. American College of Sports Medicine. 14(4), pp. 294-300.

2. Olsson, J. 2016. Swedish School of Sport and Health Sciences, GIH, Department of Sport and Health Sciences. Swedish Elite Swimmers Blood Glucose Levels During Recovery: A Descriptive Study Using Continuous Glucose Monitoring Systems
 

Libre Sense and related brand marks are owned by Abbott. Other trademarks are the property of their respective owners.

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