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* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.

† Levels out of System dynamic range.

Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=200)

† Levels out of System dynamic range.

Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=168)

DOC44383_rev-C 1:14pm 22-SEP-2021

Содержание FreeStyle Libre 3

Страница 1: ...User s Manual User s Manual Language 1 Language 2 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 2: ...DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 3: ...tment decision that may result in injury If your glucose alarms and readings from the System do not match symptoms or expectations use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions Seek medical attention when appropriate Important Safety Information Indications for Use The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time cont...

Страница 4: ... check www FreeStyleLibre com for more information about device compatibility before upgrading your phone or its operating system Contraindications Automated Insulin Dosing The System must not be used with automated insulin dosing AID systems including closed loop and insulin suspend systems MRI CT Diathermy The System must be removed prior to Magnetic Resonance Imaging MRI Computed Tomography CT ...

Страница 5: ...eive the App s optional alarms make sure these are turned on Do not force close the App The App must be running in the background to receive alarms If you force close the App you will not receive alarms Re open the App to ensure you will receive alarms If you restart your phone open your App to make sure it s working properly The App will ask for phone permissions which are needed to receive alarm...

Страница 6: ...ome operating system features may impact your ability to receive alarms For example if you use the iOS Screen Time feature add the FreeStyle Libre 3 app to the list of Always Allowed apps to ensure that you receive alarms 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 Make sur...

Страница 7: ... occur where the Sensor is not working as intended and shut it off telling you to replace your Sensor This may occur if the Sensor gets knocked off from the skin or if the System detects that the Sensor may not be performing as intended Contact Customer Service if you receive a Replace Sensor message before the end of the 14 day wear period Customer Service is available at 1 855 632 8658 7 Days a ...

Страница 8: ...eeze your Sensor Kit Store your Sensor Kit in a cool dry place Do not store your Sensor Kit in a parked car on a hot day Store the Sensor Kit between 10 90 non condensing humidity When not to use the System Do NOT use if the Sensor Kit package or Sensor Applicator appear to be damaged or if tamper label indicates Sensor Applicator has already been opened Do NOT use if Sensor Kit contents are past ...

Страница 9: ...nterstitial 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 X Rays The Sensor shoul...

Страница 10: ...e Sensor readings which could cause you to miss a severe low glucose event Ascorbic acid can be found in supplements including multivitamins Some supplements including cold remedies such as Airborne and Emergen C may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor See your health care professional to understand how long ascorbic acid is active in your ...

Страница 11: ...glucose test before making treatment decisions Add edit notes Food note Insulin Rapid or Long acting note Alarm Exercise note Time change Main menu Multiple Custom notes Share report Additional information Calendar Sensor too cold DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 12: ...mitations of the System The User s Manual includes all safety information and instructions for use Refer to your phone instructions for use for how to use your phone Go to www FreeStyleLibre com to view the Tips for Kids Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes During the first 12 hours of Sensor wear the symbol wil...

Страница 13: ...ons you use the Sensor Applicator to apply the Sensor on the back of your upper arm The Sensor has a small flexible tip that is inserted just under the skin The Sensor can be worn for up to 14 days Note The Sensor Applicator is sterile and non pyrogenic unless opened or damaged Using a non sterile or pyrogenic Sensor might cause infection Sensor Applicator Applies the Sensor to your body DOC44383_...

Страница 14: ...ible with all phones Before upgrading your phone or its operating system check www FreeStyleLibre com You must keep Critical Alerts on If this setting is turned off you will not be able to use the App so you will not receive alarms or be able to check your glucose You are responsible for properly securing and managing your phone If you suspect an adverse cybersecurity event related to FreeStyle Li...

Страница 15: ...herwise violates the manufacturer s warranty Home Screen The App Home Screen displays your current glucose glucose trend arrow and glucose graph It is automatically updated every minute with glucose data from the Sensor Main Menu Tap to access the Home Screen Alarms Logbook other history options and Connected Apps You can also access Settings Help and other DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 16: ...ing life time of Sensor Add Note Tap to add notes to the glucose reading Note Symbol Tap to review notes you ve entered Reporting Software Software can be used to create reports based on glucose readings from FreeStyle Libre 3 Sensors Go to www FreeStyleLibre com and follow onscreen instructions to access the compatible software You are responsible for keeping your computer secure and up to date f...

Страница 17: ...onfirm your glucose unit of measure and tap NEXT 7 Select how you count carbohydrates in grams or servings and tap NEXT The carbohydrate unit will be used in any food notes you enter in the App 8 The App now displays some important information Accept the requested permissions Tap NEXT after reviewing each screen 9 Apply a new Sensor and then tap NEXT Go to Starting Your Sensor Note If you need hel...

Страница 18: ... activities no bending or folding Choose a site that is at least 1 inch 2 5 cm away from an insulin injection site To prevent discomfort or skin irritation you should select a different site other than the one most recently used 2 Wash application site using a plain soap dry and then clean with an alcohol wipe This will help remove any oily residue that may prevent the Sensor from sticking properl...

Страница 19: ...om the Sensor Applicator and set the cap aside CAUTION Do NOT use if the Sensor Kit package or Sensor Applicator appear to be damaged or tamper label indicates Sensor Applicator has already been opened Do NOT put cap back on as it may damage the Sensor Do NOT touch inside Sensor Applicator as it contains a needle DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 20: ...r over the prepared site and push down firmly to apply the Sensor to your body CAUTION Do NOT push down on Sensor Applicator until placed over prepared site to prevent unintended results or injury DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 21: ... your body The Sensor should now be attached to your skin Note Applying the Sensor may cause bruising or bleeding If there is bleeding that does not stop remove the Sensor and contact your health care professional DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 22: ...lication Put the cap back on the Sensor Applicator Discard the used Sensor Applicator according to local regulations Note You can tap Help in the Main Menu to access an in app tutorial on applying a Sensor DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 23: ...hould keep your phone well charged and be sure you have access to a blood glucose monitoring system When you start your Sensor you will receive a tone and vibration If your phone s volume is turned off you will not hear the tone The NFC Near Field Communication antenna is on the top edge of iPhone Hold this area near your Sensor when you are scanning You may need to adjust your scan distance based...

Страница 24: ...ne is now ready to scan the Sensor to start it 2 Touch the Sensor with the TOP of your phone You will receive a tone and vibration after you have successfully started the Sensor If your phone s volume is turned off you will not hear the tone 3 The Sensor can be used to check your glucose after 60 minutes While the Sensor is starting up you can navigate away from the App If notifications are enable...

Страница 25: ... a Scan Error message Follow the instructions in the message See Troubleshooting for additional error messages Checking Your Glucose 1 Open the App 2 If you have an active Sensor the Home Screen displays your glucose reading It includes your Current Glucose a Glucose Trend Arrow indicating which way your glucose is going and a graph of your current and stored glucose readings DOC44383_rev C 1 14pm...

Страница 26: ...cutive readings above 350 mg dL a line is displayed at 350 mg dL The Current Glucose number can be as high as 400 mg dL The symbol may appear indicating the phone s time was changed All available glucose data is used to make your graph so you can expect to see some differences between the graph line and previous current glucose readings Your current glucose value determines the background color on...

Страница 27: ...data with other connected apps please do the following Enable WiFi or cellular service Disable Low Data mode Understanding Your Glucose Readings Glucose Trend Arrow The Glucose Trend Arrow gives you an indication of the direction your glucose is going Glucose is rising quickly more than 2 mg dL per minute Glucose is rising between 1 and 2 mg dL per minute Glucose is changing slowly less than 1 mg ...

Страница 28: ...symbol for more information Check your blood glucose on your finger with a test strip If you get a second LO or HI result after doing a blood glucose test contact your health care professional immediately Low Glucose High Glucose If your glucose is higher than 250 mg dL or lower than 70 mg dL you will see a message on the screen You can tap the symbol for more information and set a reminder to che...

Страница 29: ... than 250 mg dL or lower than 70 mg dL within 15 minutes you will see a message on the screen You can tap the symbol for more information and set a reminder to check your glucose Note The background color corresponds to your current glucose value DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 30: ...aging your diabetes that includes when to use the System information for making treatment decisions You should also talk to your health care professional about the best times to check your glucose Consider checking your glucose before a period when you will not be monitoring your glucose such as before driving exercise or sleeping WARNING The System can replace blood glucose testing except in the ...

Страница 31: ...or treatment decisions until you are comfortable with the information you receive from your System This includes understanding that Sensor performance can vary in between Sensors within a Sensor wear period up to 14 days and in different situations There may be variations between Sensors during the first 12 hours after insertion so pay attention to how each newly inserted Sensor is working for you...

Страница 32: ...o your health care professional about how your insulin works The more you understand about your insulin including how long it takes to start working and how long it lasts in your body the more likely you will be to make better treatment decisions Making a treatment decision doesn t just mean taking insulin Treatment decisions can also include things like taking fast acting carbs eating or even doi...

Страница 33: ... the System do not match your symptoms or expectations use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions When not to use Sensor Glucose readings for treatment decisions No Current Glucose Number DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 34: ...ions Don t make treatment decisions if you think your Sensor glucose readings are incorrect Do a blood glucose test and treat based on that result Symptoms Don t Match Readings There may be times when your symptoms don t match your Sensor glucose readings For example you are feeling shaky sweaty and dizzy symptoms you generally get when you have low glucose but your glucose reading is within your ...

Страница 35: ...ithin 2 hours of your meal dose This may result in insulin stacking and low glucose Using Your Glucose Reading to Make a Treatment Decision After you check your glucose use all of the information on the screen when deciding what to do or what treatment decision to make DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 36: ...ng 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 If you have taken insulin recently do nothing and check again 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 re...

Страница 37: ...dose unless you have taken insulin recently If you have taken insulin recently do nothing and check again 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 les...

Страница 38: ...ck again later High Glucose 250 mg dL If you are about to eat take insulin to cover your meal Consider taking a little less since glucose is falling quickly If this is between meals consider doing nothing and check again later Avoid insulin stacking Example Scenarios Here are some example scenarios to help you understand how to use the information on your screen Always use all of the information o...

Страница 39: ... 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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 40: ...ions during this time Confirm Sensor glucose readings with a blood glucose test before making treatment decisions during the first 12 hours of Sensor wear when you see the symbol What you see Before breakfast DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 41: ...akfast 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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 42: ...vent a high glucose For example How much insulin should you take before your meal Since you see should you consider taking a little more insulin What you see Before lunch DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 43: ...ns 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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 44: ...hat you see After lunch 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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 45: ...acking and low glucose Consider what might be causing your glucose to go up and what you might do to prevent a high glucose For example Has the insulin you took for your meal reached its full effect Check your glucose again later What you see In the afternoon DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 46: ...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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 47: ...snack to stay within target Avoid taking insulin as this can cause low glucose What you see After exercising DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 48: ...y 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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 49: ...nner 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 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 50: ...ucose is low How much time do you wait to eat after taking your meal insulin Do you adjust the amount of meal insulin based on the number of carbs or how much you are planning to eat Do you adjust your meal insulin dose for high fat foods such as pizza Do you know how to adjust your insulin doses when drinking alcoholic beverages High glucose corrections Do you take extra insulin if your glucose i...

Страница 51: ... Disturb setting is turned on by default for each of these alarms so you will receive a visual and audio notification regardless of your phone s sound or Do Not Disturb settings Note Turn OFF Override Do Not Disturb if you want the Optional Glucose Alarm volume to follow your phone s volume setting and be silent when Do Not Disturb setting is enabled Visual and Vibratory notification for the alarm...

Страница 52: ...ate you have force closed the App Please read all the information in this section before setting and using alarms CAUTION For you to receive alarms your phone should be within 33 feet of you at all times The transmission range is 33 feet unobstructed If you are out of range you may not receive alarms If you want to receive the App s optional alarms make sure these are turned on Do not force close ...

Страница 53: ...r phone s automatic operating system updates After an operating system update open your App and check your device settings to make sure it s working properly Some operating system features may impact your ability to receive alarms For example if you use the iOS Screen Time feature add FreeStyle Libre 3 to the list of always allowed apps to ensure that you receive alarms IMPORTANT The Urgent Low Lo...

Страница 54: ...rms go to the Main Menu and tap Alarms Select the alarm you want to change Work with your health care professional to determine your alarm settings Low Glucose Alarm 1 The Low Glucose Alarm is on by default The alarm level is initially set to 70 mg dL Tap to change this value between 60 mg dL and 100 mg dL If the alarm is on you will be notified when your glucose falls below the level you set Tap ...

Страница 55: ...lider to turn the alarm off Tap SAVE 2 Choose the sound for this alarm Tap SAVE 3 Override Do Not Disturb for the alarm is on by default Keep Override Do Not Disturb ON if you want the alarm to always 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 Note Turn OFF Override Do Not Disturb if you want the ...

Страница 56: ...o Not Disturb ON if you want the alarm to always 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 Note Turn OFF Override Do Not Disturb if you want the alarm volume to follow your phone s volume setting and be silent when Do Not Disturb setting is enabled Visual and Vibratory notification for the alarm ...

Страница 57: ...s at or above 55 mg dL Low Glucose Alarm Notifies you if your glucose drops below the level you set Open the App or tap the Dismiss button to dismiss the alarm You will only receive one alarm per low glucose episode High Glucose Alarm Notifies you if your glucose rises above the level you set Open the App or tap the Dismiss button to dismiss the alarm You will only receive one alarm per high gluco...

Страница 58: ...eive glucose alarms after this time unless you start a new Sensor Remove your Sensor and start a new Sensor to check your glucose Open the App or tap the Dismiss button to dismiss the alarm Note For all of the above alarms If you ignore an alarm you will receive it again in 5 minutes if the condition still exists Only your most recent alarms will display on your screen Sensor Ended Alarm Notifies ...

Страница 59: ...to your note Food notes Enter meal type and grams or serving information Insulin notes Enter the number of units taken Exercise notes Enter intensity and duration 3 Tap DONE to save your note Notes you add are shown on your glucose graph and in your Logbook as symbols Low or High Glucose Alarms you receive will also be shown in the Logbook You can review a note by tapping its symbol on your glucos...

Страница 60: ...gs notes past alarm data and other information From the Main Menu tap Logbook to view the Logbook or tap on one of the other history options under Reports IMPORTANT Work with your health care professional to understand your glucose history Logbook The Logbook contains entries for notes you added as well as each time you received an Urgent Low Low or High Glucose Alarm If you would like to view a d...

Страница 61: ...e of 70 to 180 mg dL Low Glucose Events Information about the number of low glucose events measured by your Sensor A low glucose event is recorded when your Sensor glucose reading is lower than 70 mg dL for longer than 15 minutes The total number of events is displayed below the graph The bar graph displays the low glucose events in different periods of the day Average Glucose Information about th...

Страница 62: ...71 4 70587 x mean glucose mmol L Reference Bergenstal Richard M et al Glucose Management Indicator GMI A New Term for Estimating A1C From Continuous Glucose Monitoring Diabetes Care ADA November 2018 Note Tap the symbol on any report to share a screenshot of the report Tap the symbol to view a description of the report To view a different report tap the dropdown menu above the report or go to the ...

Страница 63: ...m that you would like to start a new Sensor Note After removing your Sensor you may observe a slight bump at the insertion site This goes away quickly usually in a day or two Replacing Your Sensor Your Sensor automatically stops working after the wear duration and must be replaced You should also replace your Sensor if you notice any irritation or discomfort at the application site or if your devi...

Страница 64: ...g your glucose or taking insulin You can also set a reminder to remind you to check your alarm settings if you have turned off any of your alarms temporarily Note To receive reminders make sure notifications for the App are enabled If you want to receive a sound vibration with your reminder ensure that sound vibration on your phone is turned on sound is set at a level you can hear and your phone s...

Страница 65: ...reminder to repeat tap the slider to the right You can also select which days you would like to receive the reminder 4 Tap DONE You will now see your reminder on the list along with the time you DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 66: ...merse it longer than 30 minutes in water Bluetooth performance may be impacted if using the system while underwater Sleeping Your Sensor should not interfere with your sleep Place your device nearby so you will receive alarms and any reminders you have set Traveling by Air You may use your System while on an aircraft following any requests from the flight crew IMPORTANT You will not receive alarms...

Страница 67: ...he App Report Settings Work with your health care professional to set your Target Glucose Range which is displayed on glucose graphs in the App and used to calculate the Time in Ranges Custom report The Target Glucose Range setting will not set glucose alarm levels Tap SAVE when you are done Carbohydrate Units Choose grams or servings for food notes that you enter Tap SAVE when you are done Accoun...

Страница 68: ...further information on the appropriate disposal of system components Customer Service is available at 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time Troubleshooting This section lists problems that you may experience the possible cause s and recommended actions If there is an error a message will appear on the screen with directions to resolve the error IMPORTANT If you are hav...

Страница 69: ...nsitive to the adhesive material What to do Ensure that nothing rubs on the site If the irritation is where the adhesive touches skin contact your health care professional to identify the best solution Problems Starting Your Sensor Display Scan Error What it may mean The phone was unable to scan the Sensor What to do Tap the scan button and try scanning the Sensor again The NFC antenna is on the t...

Страница 70: ... compatible with your Sensor You may need to download a different app if your Sensor is not compatible What to do Tap Learn More to find out what Sensors can be used If you still have questions call Customer Service Display Replace Sensor What it may mean The App has detected a problem with your Sensor What to do Apply and start a new Sensor Display Allow Access to Critical Alerts What it may mean...

Страница 71: ...t your Sensor again If you see Check Sensor again on the screen your Sensor was not applied properly Remove this Sensor and apply and start a new Sensor Display Sensor Ended What it may mean Your Sensor has ended What to do Apply and start a new Sensor Display Signal Loss What it may mean Sensor has not automatically communicated with the App in the last 5 minutes What to do Make sure your phone i...

Страница 72: ...splay Sensor Too Hot What it may mean Your Sensor is too hot to provide a glucose reading Tap the symbol for more information 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 Tap the symbol for more information What to do Move to a location where the temp...

Страница 73: ...be a problem with the Sensor What to do The Sensor must be within range 33 feet of your device for you to receive alarms Make sure that you are within this range You will see the symbol at the top of the screen when your Sensor has not communicated with your device in 5 minutes If the Signal Loss Alarm is on you will be notified if there has been no communication for 20 minutes Try turning Bluetoo...

Страница 74: ... Your Sensor has ended What to do Replace your Sensor with a new one What it may mean If you are using peripherals such as wireless headphones or a smartwatch you may receive alarms on only one device or peripheral not all What to do Disconnect headphones or peripherals when you are not using them What it may mean You have closed the App What to do Make sure the App is always open in the backgroun...

Страница 75: ... to 113 F Sensor Applicator 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 one meter of water for up to 30 minutes Protected against insertion of objects 12 mm diameter Operating and storage altitude 1 250 ft 381 meters to 10 000 ft 3 048 meters Radio Frequency 2 402...

Страница 76: ...and receive glucose data Only apps logged into the same LibreView account that activated the Sensor are able to complete pairing with the Sensor Quality of Service QoS QoS for the FreeStyle Libre 3 App and Sensor wireless communications using BLE is assured at regular 1 minute intervals If connection is lost between the App and Sensor for 5 minutes the App will display an indication of Signal Loss...

Страница 77: ...is damaged Not made with natural rubber latex CAUTION Federal law restricts this device to sale by or on the order of a physician This product contains electronic equipment batteries sharps and materials that may contact bodily fluids during use Dispose of product in accordance with all applicable local regulations DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 78: ...subjects in total 91 1 Type 1 8 9 Type 2 all aged eighteen and older Subjects had their venous blood glucose analyzed over three separate visits to the clinical center Each visit lasted up to ten hours 144 subjects were analyzed during the beginning of the Sensor wear period day 1 2 or 3 91 subjects were analyzed during the early middle period day 7 or 8 55 subjects were analyzed during the late m...

Страница 79: ...d day 1 2 or 3 46 subjects were analyzed during the early middle period day 7 or 8 47 subjects were analyzed during the late middle period day 9 or 12 and 34 subjects were analyzed during the end period day 13 or 14 Accuracy Accuracy of the System was measured by comparing paired System Glucose Measurement CGM and YSI blood glucose values The percentage of total System readings that were within 20...

Страница 80: ...L For blood glucose values 70 mg dL the difference in mg dL between the CGM and YSI blood glucose values was calculated For values 70 mg dL the relative difference to the YSI blood glucose values was calculated The results categorized within CGM glucose ranges are presented in Tables 1b and 1c The results categorized within YSI glucose ranges are presented in Tables 1d and 1e Table 1b Accuracy to ...

Страница 81: ... 6 17 years of age No YSI measurements were obtained for children 4 5 years of age Agreement with LO and HI CGM Reading against YSI Reference The System reports glucose concentrations between 40 and 400 mg dL When the System determines that glucose level is below 40 mg dL it will report as LO When the System determines that glucose level is above 400 mg dL it will report as HI Tables 2a and 2b dis...

Страница 82: ...GM Reading Pediatric n 168 Includes children 6 17 years of age No YSI measurements were obtained for children 4 5 years of age Tables 2c and 2d display the concurrence between the CGM and YSI reference glucose when CGM reads HI In the Adult subject group when CGM reading was HI YSI glucose values were above 350 mg dL 97 6 of the time above 300 mg dL 100 0 of the time above 250 mg dL 100 0 of the t...

Страница 83: ...t group when the System glucose readings were within the 81 to 120 mg dL range actual blood glucose values were between 40 and 60 mg dL 0 2 of the time between 61 and 80 mg dL 9 2 of the time between 81 and 120 mg dL 71 1 of the time between 121 and 160 mg dL 19 1 of the time between 161 and 200 mg dL 1 0 of the time and between 201 and 250 mg dL 0 1 of the time Table 3a Concurrence Analysis by CG...

Страница 84: ...ined for children 4 5 years of age Levels out of System dynamic range Table 3c Concurrence Analysis by YSI Glucose Level Adult n 200 Levels out of System dynamic range Table 3d Concurrence Analysis by YSI Glucose Level Pediatric n 168 DOC44383_rev C 1 14pm 22 SEP 2021 ...

Страница 85: ...en the Sensor glucose ROC indicated that glucose was changing slowly downward 1 to 0 mg dL min actual glucose levels in the body were falling quickly 2 mg dL min 1 0 of the time falling 2 to 1 mg dL min 7 7 of the time changing slowly downward 1 to 0 mg dL min 68 0 of the time changing slowly upward 0 to 1 mg dL min 19 9 of the time rising 1 to 2 mg dL min 2 3 of the time and were rising quickly 2...

Страница 86: ...lucose event Low Glucose Alarm Performance Tables 5a and 5b display the percentages for these parameters True Alarm Rate 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 h...

Страница 87: ...bject group found that for a Low Glucose alarm level set to 70 mg dL 84 3 of the time a low glucose alarm was received when blood glucose was indeed below the alarm level but 15 7 of the time a low glucose alarm was received when blood glucose wasn t actually below the alarm level 89 0 of the time blood glucose was below the alarm level and a low glucose alarm was appropriately issued but 11 0 of ...

Страница 88: ...glucose alarm that you shouldn t have Definition Percentage of time the alarm issued and blood glucose was not above the alarm level within 15 minutes before or after the alarm Detection Rate Tells you When you were high did you get a high glucose alarm Definition Percentage of time blood glucose was above the alarm level and the alarm issued within 15 minutes before or after the glucose event Mis...

Страница 89: ...lucose wasn t actually above the alarm level 96 7 of the time blood glucose was above the alarm level and a high glucose alarm was appropriately issued but 3 3 of the time the glucose event was missed and no alarm was issued Table 5c High Glucose Alarm Performance Adult n 200 Table 5d High Glucose Alarm Performance Pediatric n 168 Includes children 6 17 years of age No YSI measurements were obtain...

Страница 90: ...L and above the percentage of readings within 15 20 and 40 of the YSI value was calculated For values below 70 mg dL the percentage of readings within 15 mg dL 20 mg dL and 40 mg dL of the YSI value was calculated Table 6a Sensor Accuracy Relative to YSI over the wear duration Adult n 200 Table 6b Sensor Accuracy Relative to YSI over the wear duration Pediatric n 168 Includes children 6 17 years o...

Страница 91: ...h day in the wear duration for Study 3 Table 7 Sensor Survival Rate Over Wear Duration n 101 Glucose Reading Availability The System is designed to log a glucose reading every minute throughout the wear period after the start up time Table 8 shows the glucose reading capture rate for each day of the wear duration for Study 3 Table 8 Glucose Reading Capture Rate Over Wear Duration n 101 DOC44383_re...

Страница 92: ... 1 with CV of 5 7 Paired absolute difference PAD is a measurement of absolute difference in mg dL between paired CGM readings while PARD is the absolute relative difference in between paired CGM readings Table 9 Overall between Sensor Precision n 100 Adverse Events No device related serious adverse events occurred during the studies In Study 1 mild skin irritations such as erythema bruising bleedi...

Страница 93: ...stand how long ascorbic acid is active in your body Additional notes for Health Care Professionals A clinical study was conducted to evaluate the effect of ascorbic acid on Sensor performance Data from 57 adult subjects with diabetes was collected over a 13 hour period Each subject had a one hour baseline phase where venous blood was collected every 10 minutes After this first hour a dose of 1000 ...

Страница 94: ...ott could void the user s authority to operate the equipment Guidance and Manufacturer s Declaration Electromagnetic Emissions The System is intended for use in the electromagnetic environment specified below The customer or the user of the System should assure that it is used in such an environment Emissions test RF emissions CISPR 11 Compliance Group 1 Electromagnetic environment guidance The Sy...

Страница 95: ...ity test Proximity fields from RF wireless communications equipment IEC 61000 4 3 IEC 60601 test level See table below Compliance level Compliance to the tested levels Electromagnetic environment guidance Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the System including cables sp...

Страница 96: ... fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System i...

Страница 97: ...Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html 3 American Diabetes Association 2019 2 Classification and Diagnosis of Diabetes Standards of Medical Care in Diabetes 2019 Diabetes Care 42 Supplement 1 pp S13 S28 Customer Service www FreeStyleLibre com Patent https www abbott com patents The circular shape of the sensor housing FreeStyle Libre and...

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