Important Safety Information
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FreeStyle Libre Indications and Important Safety Information

The FreeStyle Libre Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions.

The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

CONTRAINDICATIONS:

The FreeStyle Libre Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

WARNINGS:

  • Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
  • Checking Sensor glucose readings with a blood glucose meter: Under the following conditions, Sensor glucose readings may not be accurate and you should conduct a fingerstick test using a blood glucose meter. You should not use Sensor glucose readings to make a diabetes treatment decision:
    • If you suspect that your reading may be inaccurate for any reason
    • When you are experiencing symptoms that may be due to low or high blood glucose
    • When you are experiencing symptoms that do not match FreeStyle Libre System readings
    • During times of rapidly changing glucose (more than 2 mg/dL per minute), when interstitial fluid glucose levels as measured by the Sensor may not accurately reflect blood glucose levels
    • When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
    • In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
  • When you see the Check Blood Glucose symbol, you must check your blood glucose with a blood glucose meter before making any treatment decisions. Sensor readings may not accurately reflect blood glucose levels.
  • Hypoglycemic unawareness: The FreeStyle Libre System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you of a hypoglycemic event without you scanning your Sensor.
  • No alarms without a Sensor scan: The FreeStyle Libre System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic) or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when you are sleeping in the case of low or high glucose.
  • Choking hazard: The FreeStyle Libre System contains small parts that may be dangerous if swallowed.

Cautions and LIMITATIONS:

What to know about Alarms/Alerts:

  • There are NO alarms or alerts unless you scan the Sensor.

What to know before using the System:

  • Review all product information before use.
  • Take standard precautions for transmission of blood borne pathogens to avoid contamination.

Who should not use the System:

  • Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
  • Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in critically ill patients.
  • Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
  • Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.

What should you know about wearing a Sensor:

  • After the 12 hour start-up period, the Sensor can be worn for up to 10 days.
  • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre System. Contact your health care professional before continuing to use the FreeStyle Libre System.
  • Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site.
  • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
  • If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

  • Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don’t need to keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
  • Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

  • Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
  • Do NOT use if Sensor Kit contents are past expiration date.
  • Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

  • The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.
  • Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to your body.
  • Clean hands prior to Sensor handling/insertion to help prevent infection.
  • Change the application site for the next Sensor application to prevent discomfort or skin irritation.
  • Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
  • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. 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). Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

  • Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.

What to know about interfering substances such as Vitamin C and Aspirin:

  • Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.
  • Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.

What to know about X-Rays:

  • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.

When to remove the Sensor:

  • If the Sensor is becoming loose or if the Sensor tip is coming out of your skin, you may get no readings or unreliable readings, which may not match how you feel. Check to make sure your Sensor has not come loose. If it has come loose, remove it and apply a new one.
  • If you believe your glucose readings are not correct or are inconsistent with how you feel, perform a blood glucose test on your finger to confirm your glucose. If the problem continues, remove the current Sensor and apply a new one.

What to do if you are dehydrated:

  • Severe dehydration and excessive water loss may cause inaccurate Sensor glucose readings. If you believe you are suffering from dehydration, consult your health care professional immediately.

What to know about the Reader’s Built-in Meter:

  • The FreeStyle Libre Flash Glucose Monitoring System has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using other test strips with the Reader’s built-in meter will produce an error or cause the Reader’s built-in meter to not turn on or start a test. The Reader's built-in meter does not have ketone testing functionality.
  • The Reader’s built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
  • The Reader’s built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
  • See Using the Reader’s Built-in meter section of the User’s Manual for additional important information on the use of the Reader’s built-in meter.

Where to charge your Reader:

  • Be sure to select a location for charging that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.

 

FreeStyle Libre Pro Indications and Important Safety Information

INDICATIONS FOR USE

The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The System is intended for use by health care professionals and requires a prescription. Readings from the FreeStyle Libre Pro Sensor are only made available to patients through consultation with a health care professional. The System does not require user calibration with blood glucose values. The FreeStyle Libre Pro System aids in the detection of glucose level excursions above or below the desired range, facilitating therapy adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should be based on the trends and patterns analyzed through time using the reports available.

IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.

CONTRAINDICATIONS

The FreeStyle Libre Pro Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in the user’s glucose values during the wear period.

WARNING: The FreeStyle Libre Pro Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed.

CAUTION

  • Performances of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.
  • Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If your patient notices significant skin irritation around or under their Sensor, they should remove the Sensor and stop using the FreeStyle Libre Pro System. Follow your facility’s procedures for handling skin reactions.

WARNINGS/LIMITATIONS

  • Review all product information before use.
  • Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose readings. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising.
  • Severe dehydration and excessive water loss may cause inaccurate results.
  • Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
  • Interfering Substances: Taking ascorbic acid (vitamin C) while wearing the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid (used in some pain relievers such as aspirin and some skin care products) may slightly lower Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body. Test results did not indicate interference for methyldopa (used in some drugs to treat high blood pressure) or tolbutamide (infrequently used in some drugs to treat diabetes in the US) at maximum circulating levels. However, concentrations of potential interferents in interstitial fluid are unknown compared to circulating blood.
  • Take standard precautions for transmission of blood borne pathogens to avoid contamination.
  • The Reader should be cleaned between patients.
  • If a Sensor breaks inside a patient, remove with tweezers, treat any medical complications and call Customer Service.
  • Use of the System is not recommended in the critically ill population since performance is unknown due to different conditions and medications.
  • Sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the Sensor may not function properly.
  • If the Sensor Kit package or contents or the Reader appear to be damaged, do not use as there may be a risk of electric shock, no results, and/or infection.
  • Store the Sensor Kit between 39°F–77°F. While you don’t need to keep the Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F–77°F.
  • Store the Sensor Kit between 10–90% non-condensing humidity.
  • The System does not provide real-time results. Patients need to rely on blood glucose readings for monitoring glucose during System use.
  • Clean hands prior to Sensor handling/insertion to help prevent infection.
  • Clean the application site and ensure that it is dry prior to Sensor insertion. This helps the Sensor stay attached to the body.
  • Change the application site for the next Sensor application to prevent discomfort or skin irritation.
  • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. 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). Choose a site that is at least 1 inch away from an insulin injection site.
  • The Sensor should not be worn more than 14 days. Readings are not obtained after 14 days.
  • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of the system has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in the user’s glucose values during the wear period.
  • The FreeStyle Libre Pro Flash Glucose Monitoring System has not been evaluated for use in pregnant women, persons on dialysis, or people less than 18 years of age.
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