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Freestyle Libre 2 User Manual

App user's manual for use with freestyle libre 2 sensor and freestyle libre 2 plus sensor
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ART47276-001_rev-A 9:35am 19-SEP-2024
App User's Manual
For use with
FreeStyle Libre 2 Sensor and FreeStyle Libre 2 Plus Sensor

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Summary of Contents for Freestyle Libre 2

  • Page 1 ART47276-001_rev-A 9:35am 19-SEP-2024 App User's Manual For use with FreeStyle Libre 2 Sensor and FreeStyle Libre 2 Plus Sensor...
  • Page 2 ART47276-001_rev-A 9:35am 19-SEP-2024...
  • Page 3 Customer Service team a call if you need assistance. We're here to help. Features of the FreeStyle Libre 2 System Real-time glucose readings automatically sent every minute to your phone Optional alarms let you know the minute your glucose is too high or too low Bluetooth connection range between Sensor and App of 20 feet...
  • Page 4 Compatible Sensors You can use Libre app with the FreeStyle Libre 2 Sensor and the FreeStyle Libre 2 Plus Sensor (simply referred to as Libre 2 Sensor and Libre 2 Plus Sensor). Some of the information in this User's Manual and the performance characteristics vary between the Sensors.
  • Page 5 Indications for Use Libre 2 Sensor users: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
  • Page 6 ART47276-001_rev-A 9:35am 19-SEP-2024 diabetes. Check Compatibility Libre app is only compatible with certain phones and operating systems. Always check the Phone and OS Compatibility Guide before upgrading your phone or its operating system. This Guide is available in the App's Help Menu and at www.FreeStyleLibre.com. Authorized compatible products that you can use with your Sensor are also listed at www.FreeStyleLibre.com.
  • Page 7 ART47276-001_rev-A 9:35am 19-SEP-2024 Avoid infection by taking standard precautions for bloodborne pathogens. Don’t share the App with another person to avoid confusing glucose information. The App doesn’t share data with your System’s Reader. Before you start a Sensor, you must choose whether to use the Reader or the App with the Sensor. Once you start a Sensor, you cannot switch your device.
  • Page 8 ART47276-001_rev-A 9:35am 19-SEP-2024 list of Always Allowed apps to ensure that you receive alarms. Or, if you use an Android phone, don’t use the Android Digital Wellbeing app. If you restart your phone, open the App to make sure it’s working properly. During set up, the App asks for phone permissions.
  • Page 9 ART47276-001_rev-A 9:35am 19-SEP-2024 Disconnect headphones or speakers from your phone when not in use. You may miss alarm sounds if you don’t. Remember that if you have accessories connected to your phone (like wireless headphones or a smartwatch), you may get alarms on only one device, not all. Go to the Alarms section to learn more about the App's alarms.
  • Page 10 ART47276-001_rev-A 9:35am 19-SEP-2024 8 p.m. Eastern Time; excluding holidays. Some people 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. Contact your health care professional before continuing to use the System. Intense exercise may cause your Sensor to loosen due to sweat or Sensor movement.
  • Page 11 ART47276-001_rev-A 9:35am 19-SEP-2024 Don’t use if Sensor Kit contents have expired. Go to the Applying Your Sensor section to learn how to prepare and apply your Sensor. MRI safety information: You can safely have a 1.5T or 3T MRI exam while wearing your Sensor, under the conditions listed below.
  • Page 12 ART47276-001_rev-A 9:35am 19-SEP-2024 Mode Normal Operating Mode Maximum Whole-body SAR: 2 W/kg Conditions 1.5T scanners: Up to 1 hour of continuous scanning without cooling period. Scan 3T scanners: Up to 12 minutes of scanning between the pelvis and the Duration sternum with a cooling period of 2 minutes between scans. Up to 1 hour of continuous scanning without cooling period when scanning elsewhere.
  • Page 13 ART47276-001_rev-A 9:35am 19-SEP-2024 Interfering Substances Libre 2 Sensor Taking Vitamin C supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of Vitamin C per day may a"ect the Sensor readings. This could cause you to miss a severe low glucose event. Vitamin C can be found in supplements including multivitamins.
  • Page 14 ART47276-001_rev-A 9:35am 19-SEP-2024 decisions Add/edit notes Food note Insulin note Exercise note Multiple notes Custom note Additional information Indicates your phone's time was changed Sensor too cold Sensor too hot App Setup 1. First, check that your phone is connected to a network (WiFi or cellular). You can then download Libre app from the App Store (iPhone) or Google Play Store (Android).
  • Page 15 ART47276-001_rev-A 9:35am 19-SEP-2024 2. Review and accept the App's Terms of Use and Privacy Notice. 3. Confirm your country and then review the information about compatibility. You will not be able to proceed if the App version is either not supported in your country or not compatible with your phone and/or operating system.
  • Page 16 ART47276-001_rev-A 9:35am 19-SEP-2024 Sensor Applicator: Applies the Sensor to your body. The Sensor has a small, flexible tip that inserts just under the skin to measure your glucose readings. CAUTION: Review the safety information in Cautions - Sensor Use before you apply your Sensor.
  • Page 17 ART47276-001_rev-A 9:35am 19-SEP-2024 normal daily activities (no bending or folding). Avoid scars, moles, stretch marks or lumps, and keep at least 1 inch away from insulin injection sites. You should also rotate sites between Sensors to help prevent any skin irritation. 2.
  • Page 18 ART47276-001_rev-A 9:35am 19-SEP-2024 if the Sensor Pack or Sensor Applicator seem to be damaged or already opened. Do NOT use if past expiration date. 4. Line up the dark mark on the Sensor Applicator with the dark mark on the Sensor Pack.
  • Page 19 ART47276-001_rev-A 9:35am 19-SEP-2024 On a hard surface, press down firmly on the Sensor Applicator until it comes to a stop. 5. Lift the Sensor Applicator out of the Sensor Pack. 6. The Sensor Applicator is now ready. CAUTION: The Sensor Applicator has a tiny needle. Be careful NOT to touch inside the Sensor Applicator or put it back into the Sensor Pack.
  • Page 20 ART47276-001_rev-A 9:35am 19-SEP-2024 7. Place the Sensor Applicator over the area of your arm that you've cleaned and push down firmly to apply the Sensor to your body. CAUTION: Don't push down on the Sensor Applicator until it's placed over the site to prevent unintended results or injury.
  • Page 21 ART47276-001_rev-A 9:35am 19-SEP-2024 9. Make sure your Sensor is secure after application. Put the cap back on the Sensor Applicator. Discard the used Sensor Applicator and Sensor Pack according to local regulations. You can now wear the Sensor for up to the wear duration specified by your Sensor insert.
  • Page 22 ART47276-001_rev-A 9:35am 19-SEP-2024 Start your Sensor by scanning it with your phone’s NFC antenna (this is the antenna that lets two devices talk when they’re near each other, like Apple Pay or Google Pay). On iPhone, the NFC antenna is on the top edge. On Android phones, the location may vary between devices.
  • Page 23 ART47276-001_rev-A 9:35am 19-SEP-2024 You can still scan your Sensor whenever you want though - for example, to fill in up to 8 hours of missing data or to get a glucose reading during signal loss. Just tap the scan button and hold the top (iPhone)/ back (Android) of your phone near the Sensor.
  • Page 24 ART47276-001_rev-A 9:35am 19-SEP-2024 High Glucose Alarm Level - Your High Glucose Alarm level. Low Glucose Alarm Level - Your Low Glucose Alarm level. Add Note - Tap to add any notes you want to include. You can edit or review a note later by tapping on its symbol.
  • Page 25 ART47276-001_rev-A 9:35am 19-SEP-2024 Glucose is falling (between 1 and 2 mg/dL per minute) Glucose is falling quickly (more than 2 mg/dL per minute) Messages Below are messages you may see with your glucose readings. You can tap the symbol next to the message for more information. Low Glucose (Out of Glucose Reading Range): You will see LO on your screen if your reading is lower than 40 mg/dL.
  • Page 26 ART47276-001_rev-A 9:35am 19-SEP-2024 Background Color Your current glucose value determines the background color on your glucose reading display: Orange High glucose (above 250 mg/dL) Yellow Between the Target Glucose Range and high or low glucose level Green Within the Target Glucose Range Low glucose (below 70 mg/dL) Making Treatment Decisions Work with your health care professional to put together a plan for managing your diabetes...
  • Page 27 ART47276-001_rev-A 9:35am 19-SEP-2024 When to Use Your Blood Glucose Meter The System can replace blood glucose testing except in the below situations. These are the times when you need to do a blood glucose test before deciding what to do or what treatment decision to make: No current glucose number When there is no current glucose number, such as when you receive an error message or a...
  • Page 28 ART47276-001_rev-A 9:35am 19-SEP-2024 The below provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions. Remember that you should never make a treatment decision based on the Glucose Trend Arrow alone. Treatment decision considerations for Glucose Trend Arrow: Low Glucose (<70 mg/dL): Treat low glucose according to your health care professional’s recommendation.
  • Page 29 ART47276-001_rev-A 9:35am 19-SEP-2024 Avoid “insulin stacking”. High Glucose (>250 mg/dL): If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is high and rising quickly. If this is between meals, consider taking an insulin correction dose, unless you have taken insulin recently.
  • Page 30 ART47276-001_rev-A 9:35am 19-SEP-2024 later. Avoid “insulin stacking”. Treatment decision considerations for Glucose Trend Arrow: Low Glucose (<70 mg/dL): Treat low glucose according to your health care professional’s recommendation. Glucose in Target Range: If you are about to eat, take insulin to cover your meal. Consider taking a little less since glucose is falling.
  • Page 31 ART47276-001_rev-A 9:35am 19-SEP-2024 professional. What you see - When you wake-up What it means When you wake-up on your first day of wearing a Sensor, your current glucose is 110 mg/dL. There is also the symbol on the screen. During the first 12 hours of Sensor wear the symbol will display, and you cannot use Sensor values to make treatment decisions during this time.
  • Page 32 ART47276-001_rev-A 9:35am 19-SEP-2024 What it means Before breakfast, your current glucose is 115 mg/dL. The graph shows that your glucose is going up and so does the trend arrow Consider what might be causing your glucose to go up and what you might do to prevent a high glucose.
  • Page 33 ART47276-001_rev-A 9:35am 19-SEP-2024 What it means When you checked your glucose before lunch, it was 90 mg/dL and rising. Before eating lunch, you took enough insulin to cover the meal and a little more since your trend arrow was  What you see - After lunch...
  • Page 34 ART47276-001_rev-A 9:35am 19-SEP-2024 What it means 90 minutes later, your current glucose is 225 mg/dL. The graph shows that your glucose is still going up, and so does the trend arrow Don’t take a correction dose within 2 hours of your meal dose. This may result in “insulin stacking”...
  • Page 35 ART47276-001_rev-A 9:35am 19-SEP-2024 What it means Between meals, your current glucose is 72 mg/dL. The Glucose Going Low message tells you that your glucose is projected to be low within 15 minutes. Think about what might be causing your glucose to go low. Consider eating a snack to stay within target.
  • Page 36 ART47276-001_rev-A 9:35am 19-SEP-2024 What it means After exercising, you are feeling shaky, sweaty, and dizzy – symptoms you generally get when you have low glucose. But, your current glucose is 204 mg/dL. Anytime you get a reading that doesn’t match how you feel, do a blood glucose test. What you see - Before dinner...
  • Page 37 ART47276-001_rev-A 9:35am 19-SEP-2024 What it means Before dinner, your current glucose is 134 mg/dL. The graph shows that your glucose is going down and so does the trend arrow Consider what might be causing your glucose to go down and what you might do to prevent a low glucose.
  • Page 38 ART47276-001_rev-A 9:35am 19-SEP-2024 Glucose, High Glucose, or Signal Loss Alarm if you want the alarm to follow your phone's volume setting and be silent when you have Do Not Disturb enabled. Note: The Urgent Low Glucose Alarm can only be silenced by turning on Silent Mode. When you get an alarm, acknowledge it by opening the App or tapping the Dismiss button.
  • Page 39 ART47276-001_rev-A 9:35am 19-SEP-2024 Android phone settings: Channel notifications for the App are ON Lock Screen or Pop-up notifications for the App are ON Battery optimization is OFF Phone Media volume is ON If alarms are unavailable because of any of these settings, you will still be able to check your glucose.
  • Page 40 ART47276-001_rev-A 9:35am 19-SEP-2024 1. Silent Mode is o" by default. If you want to turn it on, tap the slider. 2. Tap the time field to set the duration. Tap Save. 3. Tap Turn On to confirm. Note: You can turn Silent Mode o" at any time before the end of the set duration. IMPORTANT: When Silent Mode is enabled, you will not hear your glucose and signal loss alarms even if you've turned on 'Override Do Not Disturb'.
  • Page 41 ART47276-001_rev-A 9:35am 19-SEP-2024 5. You'll get a Low Glucose Alarm app notification if your glucose drops below the level you set. It will include your current glucose level and direction your glucose is going. You will only receive one alarm per low glucose episode so if you dismiss it, you won't get one again until the next episode.
  • Page 42 ART47276-001_rev-A 9:35am 19-SEP-2024 setting. You won't hear a sound if you have turned on Silent Mode. 4. Tap the back button to return to the main alarm settings screen. 5. You'll get a High Glucose Alarm app notification if your glucose rises above the level you set.
  • Page 43 ART47276-001_rev-A 9:35am 19-SEP-2024 3. Override Do Not Disturb for the alarm is on by default. Keep Override Do Not Disturb on if you want the alarm to play a sound and appear on the lock screen even if your phone is muted or Do Not Disturb is on. The alarm vibration will match your phone setting.
  • Page 44 ART47276-001_rev-A 9:35am 19-SEP-2024 phone's sound, Do Not Disturb, or Silent Mode settings. These alarms cannot be modified or turned o" and indicate you are no longer receiving glucose readings or glucose alarms. Replace Sensor; Sensor Ended: Notifies you that your Sensor needs to be replaced. App Stopped: Notifies you that the App has been closed.
  • Page 45 ART47276-001_rev-A 9:35am 19-SEP-2024 components. Customer Service is available at 1-855-632-8658 7 days a week from 8 a.m. to 8 p.m. Eastern Time; excluding holidays. Troubleshooting Problems at the Sensor Application Site Problem: The Sensor is not sticking to your skin. What it may mean: The site is not free of dirt, oil, hair, or sweat. What to do: 1.
  • Page 46 ART47276-001_rev-A 9:35am 19-SEP-2024 minutes. What to do: Make sure your phone is within 20 feet of the Sensor. First try scanning your Sensor. Then try turning Bluetooth OFF then ON again. If that doesn't work, try turning your phone OFF then ON again. If Signal Loss Alarm shows again, contact Customer Service. Display: Signal Loss What it may mean: The Sensor has not automatically communicated with the App in the last 5 minutes.
  • Page 47 ART47276-001_rev-A 9:35am 19-SEP-2024 Display: New Sensor Found What it may mean: You scanned a new Sensor before your previous Sensor ended. What to do: Your phone can only be used with one Sensor at a time. If you start a new Sensor, you will no longer be able to use your old Sensor.
  • Page 48 ART47276-001_rev-A 9:35am 19-SEP-2024 Display: Sensor Too Hot What it may mean: Your Sensor is too hot to provide a glucose reading. What to do: Move to a location where the temperature is appropriate and check again in a few minutes. Display: Sensor Too Cold What it may mean: Your Sensor is too cold to provide a glucose reading.
  • Page 49 ART47276-001_rev-A 9:35am 19-SEP-2024 What to do: Check your alarm settings to confirm Silent Mode is turned o". What it may mean: You may have set an alarm level that is higher or lower than you intended. What to do: Confirm your alarm settings are appropriate. What it may mean: You have already dismissed this type of alarm.
  • Page 50 ART47276-001_rev-A 9:35am 19-SEP-2024 Sensor transmission range: 20 ft (6 meters) unobstructed Operating temperature: 50°F to 113°F Sensor Applicator and Sensor Pack storage temperature: 36°F to 82°F Operating and storage relative humidity: 10-90%, non-condensing Sensor water resistance and ingress protection: IP27: Can withstand immersion into 3 ft (1 meter) of water for up to 30 minutes.
  • Page 51 Overview of Clinical Studies Two studies were conducted in the United States (US) to evaluate the performance, safety, e"ectiveness, and precision of the FreeStyle Libre 2 System (System) with the Libre 2 Sensor. One study included adults (Adult study) and the other study included children (Pediatric study).
  • Page 52 ART47276-001_rev-A 9:35am 19-SEP-2024 91 subjects were analyzed during the early middle period (day 7 or 8), 55 subjects were analyzed during the late middle period (day 9 or 12), and 76 subjects were analyzed during the end period (day 13 or 14). During each visit, adult subjects had their glucose levels deliberately manipulated per the study protocol to raise or lower glucose.
  • Page 53 ART47276-001_rev-A 9:35am 19-SEP-2024 Children 85.9 87.9 90.9 11.8 (age 4-5) *  No YSI measurements were obtained for children ages 4-5; results displayed are from CGM-SMBG matched paired measurements. The following tables give you further accuracy information within CGM glucose ranges (Table 2 Table 3) and within YSI glucose ranges (Table 4...
  • Page 54 ART47276-001_rev-A 9:35am 19-SEP-2024 181-250 2937 87.9 93.7 99.7 -8.0 >250 4826 90.9 95.9 99.7 -11.8 Table 5. Accuracy to YSI within YSI Glucose Ranges (Pediatric ; n=129) Number Percent Percent Percent Percent Percent Percent Mean Glucose of CGM- Within Within Within Within Within...
  • Page 55 ART47276-001_rev-A 9:35am 19-SEP-2024 glucose. In the Adult study, when CGM reading was ‘HI’, YSI glucose values were above 350 mg/dL 97.5% of the time, above 300 mg/dL 100.0% of the time, above 250 mg/dL 100.0% of the time, and less than or equal to 250 mg/dL 0.0% of the time. Table 8.
  • Page 56 ART47276-001_rev-A 9:35am 19-SEP-2024 161-200 10.6 60.6 26.9 1745 201-250 65.5 25.6 2181 251-300 66.9 22.7 2327 301-350 13.6 68.8 16.0 1522 351-400 27.5 63.3 62.8 34.7 ✝ >400 ✝  Levels out of System dynamic range. Table 11. Concurrence Analysis by CGM Glucose Level (Pediatric ;...
  • Page 57 ART47276-001_rev-A 9:35am 19-SEP-2024 301-350 29.8 58.9 1777 351-400 34.7 48.1 10.8 >400 16.7 42.6 38.9 ✝  Levels out of System dynamic range. Table 13. Concurrence Analysis by YSI Glucose Level (Pediatric ; n=129) CGM Glucose Level (mg/dL) Glucose Level 121- 161- 201- 251-...
  • Page 58 ART47276-001_rev-A 9:35am 19-SEP-2024 (mg/dL/min) <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2 <-2 (↓) 34.4 44.9 18.3 -2 to -1 (↘) 46.5 41.2 1090 -1 to 0 (→) 67.1 19.7 9389 0 to 1 (→) 26.0 46.9 15.5 5420 1 to 2 (↗) 31.6 38.4 20.5...
  • Page 59 ART47276-001_rev-A 9:35am 19-SEP-2024 Detection Rate Tells you: When you were low, did you get a low glucose alarm? Definition: Percentage of time blood glucose was below the alarm level and the alarm issued within 15 minutes before or after the glucose event. Missed Detection Rate Tells you: When you were low, did you miss a low glucose alarm? Definition: Percentage of time blood glucose was below the alarm level and the alarm didn’t...
  • Page 60 ART47276-001_rev-A 9:35am 19-SEP-2024 *  Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age. High Glucose Alarm Performance Table 18 Table 19 display the percentages for these parameters: True Alarm Rate Tells you: When you got a high glucose alarm, were you actually high? Definition: Percentage of time the alarm issued and blood glucose was above the alarm level within 15 minutes before or after the alarm.
  • Page 61 ART47276-001_rev-A 9:35am 19-SEP-2024 High Glucose Correct Missed Alarm Level Number of True Alarm False Alarm Number of Detection Rate Detection Rate (mg/dL) Events (n) Rate (%) Rate (%) Events (n) 105544 99.1 11417 98.2 93574 99.1 10152 98.1 74290 99.2 8080 97.8 66039...
  • Page 62 ART47276-001_rev-A 9:35am 19-SEP-2024 Late Middle 3503 86.8 93.4 99.7 3755 86.4 92.9 100.0 Table 21. Sensor Accuracy Relative to YSI Over Wear Duration (Pediatric ; n=129) Number of CGM- Within ±15% / Within ±20% / Within ±40% / Wear Period MARD (%) Reference Pairs ±15 mg/dL ±20 mg/dL ±40 mg/dL...
  • Page 63 ART47276-001_rev-A 9:35am 19-SEP-2024 91.1 90.4 87.0 84.9 82.2 77.3 76.6 71.8 71.1 Table 23. Sensor Survival Rate Over Wear Duration (Pediatric; n=139) Day of Wear Number of Sensors Survival Rate (%) 98.6 97.8 97.1 96.4 96.4 96.4 96.4 94.9 91.3 89.9 88.4 87.0...
  • Page 64 ART47276-001_rev-A 9:35am 19-SEP-2024 98.3 98.4 98.3 98.4 98.4 98.4 98.4 98.4 98.5 98.5 98.6 Table 25. Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=139) Day of Wear Number of Sensors Capture Rate (%) 94.6 94.9 95.2 95.3 95.5 95.6 96.0 95.9 95.7...
  • Page 65 ART47276-001_rev-A 9:35am 19-SEP-2024 readings. Table 26. Overall between Sensor Precision (Adult; n=146) Paired Absolute Coe"cient of Paired Absolute Number of Paired Relative Di#erence Variation (%) Di#erence (mg/dL) Readings Adults ages 18+ 12.4 26791 Table 27. Overall between Sensor Precision (Pediatric; n=137) Paired Absolute Coe"cient of Paired Absolute...
  • Page 66 A clinical study was conducted in the United States (US) to evaluate the performance, safety, e"ectiveness, and precision of the FreeStyle Libre 2 System (System) with the Libre 2 Plus Sensor. The study enrolled a total of 285 evaluable participants in 7 centers across the United States and included adult (18 years and older) and pediatric (2 to 17 years) participants.
  • Page 67 ART47276-001_rev-A 9:35am 19-SEP-2024 relative di"erence (%) to the YSI blood glucose values was calculated. The percentage of total CGM readings that were within 20 mg/dL or 20% of YSI blood glucose values is displayed in Table 1. The Mean Absolute Relative Di"erence (MARD) gives an indication of the average percent disagreement between the CGM and the reference.
  • Page 68 ART47276-001_rev-A 9:35am 19-SEP-2024 54-69 84.5 88.6 97.5 -6.9 11.2 70-180 3074 82.6 90.9 99.6 -8.1 181-250 1176 92.0 97.4 100.0 -11.2 >250 1845 98.3 99.8 100.0 -3.5 *  Includes children 6-17 years of age. No YSI measurements were obtained for children 2-5 years of age. Table 4.
  • Page 69 ART47276-001_rev-A 9:35am 19-SEP-2024 Cumulative % 100.0 100.0 100.0 100.0 Table 7. Distribution of YSI Values when CGM Reading is 'LO' (Pediatric ; n=124) YSI (mg/dL) CGM-Reference Pairs <50 <60 <70 <80 >80 Cumulative % 75.0 100.0 100.0 *  Includes children 6-17 years of age. No YSI measurements were obtained for children 2-5 years of age. Table 8 Table 9 show the comparison of a CGM 'HI' reading to the reference YSI...
  • Page 70 ART47276-001_rev-A 9:35am 19-SEP-2024 Table 10. Concurrence Analysis by CGM Glucose Level (Adult; n=149) YSI Glucose Level (mg/dL) Glucose Level 121- 161- 201- 251- 301- 351- <40 40-60 61-80 81-120 >400 (mg/dL) ✝ 100.0 <40 40-60 53.1 42.1 1929 61-80 12.2 68.0 19.0 3112...
  • Page 71 ART47276-001_rev-A 9:35am 19-SEP-2024 Glucose 121- 161- 201- 251- 301- 351- 40-60 61-80 81-120 Level ✝ ✝ <40 >400 (mg/dL) <40 92.9 40-60 72.5 26.9 1412 61-80 25.8 67.2 3151 81-120 18.3 73.8 3233 121-160 24.7 67.6 2754 161-200 24.6 64.3 2011 201-250 19.3...
  • Page 72 ART47276-001_rev-A 9:35am 19-SEP-2024 changing slowly downward (-1 to 0 mg/dL/min), actual glucose levels in the body were falling quickly (<-2 mg/dL/min) 1.5% of the time, falling (-2 to -1 mg/dL/min) 7.8% of the time, changing slowly downward (-1 to 0 mg/dL/min ) 65.8% of the time, changing slowly upward (0 to 1 mg/dL/min ) 21.1% of the time, rising (1 to 2 mg/dL/min ) 2.6% of the time, and were rising quickly (>2 mg/dL/min) 1.2% of the time.
  • Page 73 ART47276-001_rev-A 9:35am 19-SEP-2024 Tells you: When you got a low glucose alarm, were you actually low? Definition: Percentage of time the alarm issued and blood glucose was below the alarm level within 15 minutes before or after the alarm. False Alarm Rate Tells you: Did you get a low glucose alarm that you shouldn’t have? Definition: Percentage of time the alarm issued and blood glucose was not below the alarm level within 15 minutes before or after the alarm.
  • Page 74 ART47276-001_rev-A 9:35am 19-SEP-2024 Table 17. Low Glucose Alarm Performance (Pediatric ; n=124) Alarm Rate Detection Rate Low Glucose Alarm Level Correct Missed Number of True Alarm False Alarm Number of (mg/dL) Detection Rate Detection Rate Events (n) Rate (%) Rate (%) Events (n) 2760 58.9...
  • Page 75 ART47276-001_rev-A 9:35am 19-SEP-2024 98.5% of the time a high glucose alarm was received when blood glucose was indeed above the alarm level but 1.5% of the time a high glucose alarm was received when blood glucose wasn’t actually above the alarm level. 98.0% of the time blood glucose was above the alarm level and a high glucose alarm was appropriately issued but 2.0% of the time the glucose event was missed and no alarm was issued.
  • Page 76 ART47276-001_rev-A 9:35am 19-SEP-2024 or 7; Pediatric: 51 subjects, Day 5, 6, or 7), Late Middle (Adult: 90 subjects, Day 9, 10, or 11; Pediatric: 35 subjects, Day 9, 10, or 11), and End (Adult: 95 subjects, Day 13, 14, or 15; Pediatric: 33 subjects, Day 13, 14, or 15).
  • Page 77 ART47276-001_rev-A 9:35am 19-SEP-2024 message. Table 22 Table 23 display the data for each day in the wear duration for the adult and pediatric populations. Another clinical study was also conducted to further evaluate wear duration in subjects who wore only a single Sensor. Of the 39 Sensors evaluated in this study, 94.9% lasted until the final day of use.
  • Page 78 ART47276-001_rev-A 9:35am 19-SEP-2024 87.7 85.4 79.3 77.7 76.8 Glucose Reading Availability The System is designed to show a Sensor glucose reading after each scan that is performed throughout the wear period after the start-up time. Table 24 Table 25 show the expected glucose reading capture rate for each day of the wear duration.
  • Page 79 ART47276-001_rev-A 9:35am 19-SEP-2024 97.0 96.8 96.6 96.6 96.5 96.4 96.3 96.3 96.1 Precision Precision of the System was evaluated by comparing the glucose readings from two separate Sensors worn on the same subject at the same time. Table 26 provides data from 148 adult participants and 136 pediatric participants.
  • Page 80 99.2% said their Sensor insertions were painless (no, slight, or mild pain). (n=242) Electromagnetic Compatibility (EMC) Libre 2 Sensor and Libre 2 Plus Sensor - FCC ID: QXS-LIB02S or QXS-LIB02S2 Please see the Sensor kit carton for the assigned FCC ID for your product.
  • Page 81 ART47276-001_rev-A 9:35am 19-SEP-2024 Abbott Diabetes Care could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Sensor and result in improper operation. The Sensor should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Sensor should be observed to verify normal operation in the configuration in which it will be used.
  • Page 82 ART47276-001_rev-A 9:35am 19-SEP-2024 Immunity test: Electrostatic discharge (ESD); IEC 61000-4-2 IEC 60601 test level: ±8 kV contact; ±2 kV, 4 kV, 8 kV, 15 kV air Compliance level: ±8 kV contact; ±2 kV, 4 kV, 8 kV, 15 kV air Electromagnetic environment – guidance: Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Immunity test: Power frequency (50/60 Hz);...
  • Page 83 ART47276-001_rev-A 9:35am 19-SEP-2024 GMRS 460, FRS ±5 kHz 430-470 deviation 1 kHz sine Pulse modulation 704-787 LTE Band 13, 17 217 Hz GSM 800/900, Pulse TETRA 800, 800-960 iDEN 820, modulation CDMA 850, LTE 18 Hz Band 5 1720 GSM 1800; CDMA 1900; Pulse GSM 1900;...
  • Page 84 fluids during use. Dispose of product in accordance with all applicable local regulations. Patent: www.abbott.com/patents The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. Manufacturer: ©2024 Abbott...
  • Page 85 ART47276-001_rev-A 9:35am 19-SEP-2024...