Page 1 Bionic ® Pancreas System User Guide LA000081_D...
Page 2 © 2023 Beta Bionics, Inc. Beta Bionics® and iLet® are registered trademarks of Beta Bionics, Inc. Bionic Pancreas™ and iLet Bionic Pancreas™ are common law trademarks of Beta Bionics, Inc. All rights reserved. All other trademarks are the property of their respective owners.
Page 3 The iLet® Bionic Pancreas System is an insulin delivery system that automatically regulates blood glucose (BG) levels. The iLet Bionic Pancreas System is the same as the iLet System, which uses autonomous lifelong learning to calculate and deliver insulin doses and to continually adapt these doses to your changing insulin needs.
Page 4: Table Of Contents
Enter Weight and Go Bionic Important Pediatric and Caregiver User Information Living with Your iLet System General Warnings and Precautions What to Expect from Your iLet System 48 Potential Risks Compatible iCGMs Maintaining your iLet System When Your CGM Sensor is Offline...
Page 5 The Insulin-Only Bionic Pancreas Returned Goods Warranty Extension Study References Technical Information iLet Dosing Decision Software iLet System Specifications (iLet Device, CGM Sensor, and CGM Transmitter) iLet Device Specifications iLet System Delivery Accuracy Explanation of Symbols iLet Bionic Pancreas System User Guide...
Page 6 Page intentionally left blank iLet Bionic Pancreas System User Guide...
Page 7: Important User Information
1.1 About This User Guide 1.1.1 Overview The iLet Bionic Pancreas System consists of the iLet bionic pancreas (iLet ACE Pump with iLet Dosing Decision Software), its disposables, a continuous glucose monitor and an infusion set (see Section 2.2 Parts of Your iLet System for details).
Page 8 CAUTION: Statement that alerts the user to the possibility of a problem with the device associated with its use or misuse (i.e., device malfunction). 1.1.3 Definitions The “iLet Bionic Pancreas System” is the same as the “iLet System”. The “iLet Device” is made of the “iLet ACE Pump” and “iLet Decision Dosing Software”. 1.1.4 Abbreviations...
Page 9: Indications For Use
1.2 Indications for Use The person with diabetes is an intended operator of the iLet bionic pancreas, which consists of the iLet ACE Pump and the iLet Dosing Decision Software. The iLet bionic pancreas is for use according to the following: •...
Page 10: Insulin Compatibility
Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription. 1.3 Insulin Compatibility The iLet ACE Pump and iLet Dosing Decision Software are designed to use rapid-acting U-100 insulin.
Page 11: Important Pediatric And Caregiver User Information
Consult with your child’s healthcare provider about how to safely secure the components of the iLet System. WARNING: Keep all parts of the iLet System out of the reach of children. The iLet System contains small parts (i.e., USB cables, insulin infusion sets with flexible tubing, needles, syringes, and cartridges).
Page 12: General Warnings And Precautions
WARNING: The iLet ACE Pump and Dosing Decision Software are only for use with U-100 Fiasp insulin in the prefilled Fiasp PumpCart. Do not use U-100 Fiasp insulin from a vial with the iLet ACE Pump and Dosing Decision software, as that has not been studied.
Page 13 System to alert you. WARNING: Do not try to open or repair your iLet Device. It is a sealed device that should not be opened. Modification could result in improper functioning and safety risks. If your iLet Device seal is broken, your iLet Device is no longer watertight and the warranty is voided.
Page 14: Potential Risks
CAUTION: Do not place any part of your iLet System in water. If your iLet System has been exposed to water, check for any signs of water entering your iLet System. If there are signs of water entry, stop using your iLet System and use an alternative therapy.
Page 15 CGM Inaccuracies • Your iLet Device relies on CGM values to dose appropriately. Inaccurate CGM values could lead to under or over delivery of insulin (e.g., when your BG values are rapidly rising or falling).
Page 16 SMBG meter. Consider treatment and/or CGM sensor calibration if necessary. • Your CGM and iLet Device will alert you when a CGM calibration is needed. • Your CGM and infusion set should be placed at least 3 inches apart on the body.
Page 17: Compatible Icgms
This can cause missing severe hypoglycemia or hyperglycemia events. CAUTION: Do not separate the CGM sensor and iLet Device by more than 20 feet. The range from the sensor to the iLet Device is less than 20 feet without obstruction.
Page 18: System
System 2.1 iLet System Overview The iLet Bionic Pancreas System is a closed-loop system that delivers insulin based on input from an integrated continuous glucose monitor (iCGM) in order to automatically regulate blood-glucose (BG) levels (see Figure 1). The iLet System uses autonomous lifelong learning to calculate and deliver insulin doses and to continually adapt these doses to your changing insulin needs.
Page 19: Parts Of Your Ilet System
Replace the following disposable parts (b, e, f, and g) every 2-3 days: b. iLet Cartridge: Glass container with a soft membrane on top called a septum and a red rubber plunger. iLet Cartridge is filled with insulin and inserted into your iLet Device.
Page 20 Parts of Your iLet System Cannula Flexible tubing Figure 2 iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
Page 21: Ilet Device
See Section 6.2.1 Troubleshooting Device Power for what to do if your iLet Device has run out of power. If your iLet runs out of power, the time of powering down and data contents of the alarm system log shall be saved. If the log reaches capacity, your iLet will alert you, and will also discard the oldest data as newer data is generated.
Page 22 It typically takes approximately 2 hours to charge a depleted battery. A fully charged iLet Device will stay on for 4 to 5 days. Your iLet Device’s battery life depends on the amount of usage, including the backlight and the amount of insulin delivered.
Page 23 Device • If the charger status light is blinking, your iLet Device is not charging properly. Remove your iLet Device from the charger for at least 10 seconds and then place it back on the charger. 2.3.2 Using the Touchscreen You can navigate the touchscreen with your fingers.
Page 24: Features And Icons
The circle will spin when the iLet is running. Glucose Status Tap to view a graph of CGM and insulin dosing data and a therapy summary screen. Meal Deliver insulin for meals with carbohydrates. Announcement iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
Page 25 Notifications icon (see Figure 9). The number of currently active alerts will appear in the Notifications icon. A bell icon will also appear in the status bar, next to the battery icon (see Section 5.1 iLet System Alerts Overview for a list of alerts).
Page 26 CGM sensor has never been paired with your iLet Device. CGM sensor data is not available. CGM sensor is not connected. CGM sensor is stopped. CGM glucose value is not available. CGM sensor is warming up. iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
Page 27 If you notice large gaps between the CGM glucose values, make sure your iLet Device and the CGM sensor are connected. The iLet Device will alert you when it has lost connection with your CGM sensor for 30 minutes or more.
Page 28 Tap the Menu icon in the upper left of the Home Screen to access the menu (see Figure 12). To close the Menu screen, tap the X tab (see Figure 13). Figure 12 Figure 13 iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
Page 29: Settings Menu
View and adjust the volume level of your iLet Device (see Volume Section 2.7 Volume for instructions). 2.5 Settings Menu Settings allow you to adjust features of your iLet Device (see Figure 14). Figure 14 Figure 15 iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
Page 30 Settings Menu 2.5.1 About iLet View details about your iLet Device in a scrollable list (see Figure 15). Your iLet Device's Serial Number is located here for reference. The Serial Number may also be found on the back panel of the iLet Device.
Page 31 Time - Adjust the time displayed on your iLet Device’s clock. Date - Adjust the date of your iLet Device. Always On Display - Enable or disable the Always On Display, which provides info at a glance. iLet Bionic Pancreas System User Guide | Getting to Know Your iLet System...
Page 32 Turn off your iLet Device for storage. Go into Settings and choose Other, then choose Shutdown (see Figure 23). All dosing will stop. To turn the iLet Device back on, place the iLet Device on the charger. Upon waking up if the battery has been fully depleted, the iLet Device may require you to go through the iLet Startup Sequence again.
Page 33: History
Figure 25 2.5.4.4 Factory Reset Return your iLet Device to factory settings. This will erase all settings, learnings, and CGM sessions. You will need to set up your iLet Device again (see Figure 26). Figure 26 2.6 History Tap the History icon in the Menu to view the event history (see Figure 27).
Page 34 4. BG Entered (numeric value, if applicable) 5. Meal Size (carb amount chosen, if applicable) 2.6.6 Insulin History Tap Insulin History to view a list of iLet insulin history for total daily basal insulin and meal announcements (see Figure 29). Figure 29...
Page 35: Volume
Tap the Volume icon (see Figure 31). Select the volume you want. Tap any of the four options to play the volume. iLet will still vibrate when the volume is set to Off, and will still beep when charging begins (see Figure 32).
Page 36: Getting Started With Your Ilet System
Device vibrate. Confirm that you can see the battery charging indicator on the charger and on your touchscreen when your iLet Device is placed on the charger. If any of these features are not working, discontinue the use of your iLet System and contact your healthcare provider and Beta Bionics.
Page 37: Preparing To Set Up Your Ilet System
Cartridge on a clean surface. 3.1 Preparing to Set Up Your iLet System When you turn on your iLet Device for the first time, instructions on the touchscreen will guide you on how to get started. 3.1.1 Turn on Your iLet Device a.
Page 38: Setting Up Your Ilet System
Device. • If you navigate away from the iLet Setup list, you can return by tapping the Alert icon and then tapping iLet Setup again. WARNING: DO NOT start to use your system without adequate training from your HCP and/or a certified iLet trainer.
Page 39 If you need to start a new sensor, follow the prompts on this screen and insert the sensor according to the manufacturer’s instructions before tapping Next The iLet Device will return to the iLet Setup Menu, and the CGM sensor row will be checked off.
Page 40 Setting Up Your iLet System it will need to be unpaired from that device before it can be paired with the iLet Device. Your transmitter can remain paired to a smartphone. Once the transmitter is paired, your iLet Device will start displaying your current CGM glucose and trend arrow if available on the home screen.
Page 41 System. It can be unsafe to use accessories, detachable parts and materials not described in the instructions for use. Secure the iLet Device to your body in any orientation of your choosing to avoid the iLet Device falling, dropping or damaging the tubing line.
Page 42 Replace the cartridge, tubing line, and/or Luer connector with new components following the appropriate procedures in this User Guide. Your iLet Device will notify you when your iLet Cartridge is low (20 units) or CAUTION: empty. When this happens, be prepared to change your iLet Cartridge soon. When your iLet Cartridge is empty, your iLet Device cannot dose insulin.
Page 43 Figure 47). Make sure the plunger of the syringe is at 1.8 mL (about halfway between the 1.5 mL and 2 mL marks). Figure 46 Figure 47 iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 44 1.8 mL. c. Remove the syringe needle from the insulin vial and set the vial aside. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 45 If needed, pull back slightly on the syringe plunger rod and remove as much air from the cartridge as you can. See Section 3.2.3.4 Removing Air Bubbles from the iLet Cartridge, and Section 3.2.3.5 Adding More Insulin After Bubbles Have Been Removed.
Page 46 The needle tip should now be surrounded by the air bubble. Pull back on the plunger until the air bubble has been removed. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 47 When using an insulin infusion set or an iLet Connect, check for damage. In the event that the packaging is already opened, do not use the insulin infusion set or iLet Connect. Contact Beta Bionics for additional assistance.
Page 48 Figure 59 hyperglycemia, or air can get it in and push insulin into your body, causing hypoglycemia. Do not connect the iLet Connect to the insulin cartridge yet. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 49 3.2.3.8 Insert the Cartridge WARNING: Do not attach a filled insulin cartridge and Luer adapter outside of your iLet Device. This can tear the septum of the cartridge, which can cause insulin to leak out of the cartridge. This can cause high BGs, and if prolonged, may cause very high BGs or DKA.
Page 50 3.2.3.9 Fill the Tubing CAUTION: Check to make sure tubing is not connected to your body. Always disconnect iLet Device from the insulin infusion set when using the Fill Tubing function. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 51: Insulin Set
Placing your insulin infusion set in these areas can cause swelling, irritation, or infection. This can affect insulin absorption and cause high or low BG. CAUTION: Change insulin infusion set every 2 to 3 days or as recommended by your healthcare iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 52 Drag the Fill slider to the right (see Figure 69). d. The iLet will begin filling your insulin infusion set cannula with insulin. You will see a progress bar until the fill is complete. iLet Bionic Pancreas System User Guide | Getting Started With Your iLet System...
Page 53: Enter Weight And Go Bionic
WARNING: Do not change your body weight in your iLet Device without consulting your healthcare provider first. If your body weight changes significantly, contact your healthcare provider to determine if an adjustment to your body weight setting is required.
Page 54: Living With Your Ilet System
Low BG levels may occur if insulin delivery outside of your iLet System is used because your iLet System will not be able to include it in its calculations, which may result in over-delivery of insulin. Contact your healthcare provider if you have concerns.
Page 55: Maintaining Your Ilet System
Maintaining your iLet System 4.2 Maintaining your iLet System There are important steps you must take to maintain your iLet System to ensure your device is working properly and avoid interruptions to your diabetes care. If the iLet System is not maintained properly, it could lead to hyperglycemia and DKA..
Page 56 Attach the tubing to the iLet Connect. Make sure this connection is straight and tight. If this connection is not tight, insulin can leak out causing hyperglycemia, or air can get it in and push insulin into your body, causing hypoglycemia.
Page 57 Figure 75 It is not required to replace your insulin infusion set at the same time as when you change your iLet cartridge, iLet Connect and tubing. These can be changed separately. • If you are replacing your iLet cartridge, iLet connect and tubing but not your infusion set, make sure to connect your newly filled tubing to your existing infusion set base on your body.
Page 58 Discard the old sensor Figure 77 Figure 78 f. Return to the CGM menu on your iLet Device. Tap Start Sensor (see Figure 78) iLet Bionic Pancreas System User Guide | Living with Your iLet System...
Page 59 CGM icon when the transmitter is paired. It can take up to 30 minutes for the transmitter to pair with the iLet Device. Once the transmitter is paired, the warmup period for the sensor will begin. The iLet Device will display the time remaining in the warmup period on the home screen. When the warmup period is complete, your CGM glucose will be displayed.
Page 60 CGM icon when the sensor is paired. It can take up to 30 minutes for the sensor to pair with the iLet Device. Once the sensor is paired, the warmup period for the sensor will begin. The iLet will display the time remaining in the warmup period on the home screen. When the warmup period is complete, your CGM glucose will be displayed.
Page 61 System. You can help to maintain this Bluetooth connection by wearing the sensor and the iLet Device on the same side of your body and keeping the screen of the iLet Device facing out when it is in your pocket.
Page 62: When Your Cgm Sensor Is Offline
Enter a BG at the start of your meal and 2 hours after for optimal glucose control. As always, if you treat a low glucose with rapid-acting carbohydates, do NOT announce that as a meal. iLet Bionic Pancreas System User Guide | Living with Your iLet System...
Page 63 CGM stops providing glucose data to the iLet System, BG-run mode will serve to continue a safe level of insulin delivery, but it will not provide the same level of glucose control as the iLet System with CGM. BG-run use SHOULD BE TEMPORARY and always for the shortest duration possible with the goal to resume CGM-guided iLet System insulin dosing AS SOON AS POSSIBLE.
Page 64 (see Figure 85) and alert screen will provide the time remaining until insulin is suspended. The alert screen will show the time remaining to enter a BG to avoid insulin suspension as well as the time remaining until the iLet System must receive a CGM value to continue dosing.
Page 65 (see Figure 88). The iLet System must receive a CGM value to resume dosing. Entering a BG value will not resume insulin dosing. If the iLet System will not be receiving a CGM value soon, switch to alternative therapy as advised by your healthcare provider and disconnect from the iLet System.
Page 66: Mobile Device
It is not advised to install any app from a source other than the Apple App store or Google Play Mobile store on your smartphone that is running the iLet App. Doing so may put you at risk of unintentionally installing malware on your device. iLet Bionic Pancreas System User Guide | Living with Your iLet System...
Page 67: Managing Highs And Lows
CGM glucose values and trends. You will still experience high and low CGM glucose values that require your attention while using the iLet System. • It is important to be patient with the iLet System as it adapts to your insulin needs and responds to your changing glucose levels •...
Page 68 • Is connected to the tubing and your infusion set • Is not leaking insulin anywhere between the iLet System and your body (make sure there is no evidence of wetness or smell of insulin anywhere along the tubing and at the infusion site) •...
Page 69 Managing Highs and Lows • If everything looks like it’s working, give the iLet System time to respond to your glucose levels. Continue to monitor your glucose until it returns to a normal range. Change your insulin infusion site if you have any suspicion that it is not working.
Page 70 Managing Highs and Lows 4.5.3 When your Glucose Level is Low Your iLet System will reduce or stop insulin dosing in response to low or falling CGM glucose levels. Always make sure to have rapid-acting carbohydrates and emergency glucagon available to respond to low glucose levels. Make sure your CGM alarms are turned on and you can hear them.
Page 71: Meal Announcements
4.6 Meal Announcements Although the iLet System does not require a user to enter an exact carb amount to calculate and administer a meal bolus, it does require that the user announce the meal as “Breakfast”, “Lunch”, or “Dinner”...
Page 72 • It is important to choose your meal size based on the amount of carbs in the meal, NOT the total size of the meal or the amount of protein, fiber, or fat. • Although the iLet System does not require you to count carbs, meals are announced as having Usual for me, More, or Less carbs.
Page 73 Figure 99 Once the iLet System has undergone the initial adaptation for that meal (through use of the “Usual For Me” or “More” carb amount options), the Less option will become available to select.
Page 74 (see Figure 104). If this occurs, tap Dismiss. Wait up to five minutes before trying again. Figure 104 iLet Bionic Pancreas System User Guide | Living with Your iLet System...
Page 75 - Only think about the carbs in your meal when selecting the size, not fat or protein. • The iLet System has an initial learning period while it is learning how much insulin you need for meals.
Page 76 A. You do not need to eat a bedtime snack to keep your blood glucose in range overnight while using the iLet System. If you chose to eat before bed, you should announce it to the iLet System the same as you would during the day. This will give you insulin up-front and help prevent additional dosing in response to the rise in glucose after you eat and reduce the risk of hypoglycemia during the night.
Page 77 Q. I think the iLet System has not learned my meal doses because my glucose is high after meals. Is there anything I can do? A. You may need to take a few days and focus on helping the iLet System learn about your meals.
Page 78: Exercise
This will NOT work on the iLet System. • If you do this before exercise while still connected to the iLet System, the iLet System will iLet Bionic Pancreas System User Guide | Living with Your iLet System...
Page 79 • Make sure you can still monitor your CGM glucose and hear your CGM alarms using your CGM app on a smartphone. Keep your iLet Device close by to hear the alarms if you do not have a smart phone.
Page 80: Illnesses
Illnesses Option 2: Stay Connected to the iLet Device You may wish to remain connected to your iLet Device during exercise. The iLet Device will continue to increase or decrease insulin dosing in response to your CGM glucose levels. • DO NOT “pre-load” with carbs.
Page 81: Responding To Alerts
Display a symbol with an exclamation point in the Notifications list. e. Display an alert message. CAUTION: Check your iLet Device regularly for any displayed alerts. Respond as soon as possible to conditions that may affect insulin delivery or require immediate action.
Page 82 5 vibrations. These action. monitor your CGM will escalate to the glucose until it returns highest volume level to range. after 5 minutes. The alert will not stop until acknowledged or resolved. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 83: Cgm And Glucose Alerts
Glucose Prepare to treat your low glucose as advised Medium Falling by your healthcare provider. Monitor your BG (Level 3) Quickly levels closely. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 84 Change your sensor now. Expired (Level 1) Sensor Failed Change your sensor now. (Level 1) Replace Your Replace with a new CGM and start a new Sensor (Level 1) sensor session. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 85 Check your transmitter SN. Pair again. If the issue continues, contact Beta Bionics. Transmitter Not Found (Level 1) If not using a G6 sensor, switch your sensor type to the appropriate sensor. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 86 You get a 12 hour grace period to replace Sensor your sensor. The sensor will continue to Expired (Level 1) function as normal during this time. Change your sensor within the next 12 hours. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 87: Insulin Delivery Alerts
Insulin Very Medium Less than 5 units of insulin remain. Change (Level 3) your cartridge soon. Change Medium Your insulin cartridge is empty. Change Insulin (Level 3) your cartridge now. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 88: Battery Alerts
(Level 3) possible to avoid shutdown. 5.5 Reminders Screen Alert Priority What to do Follow the on-screen directions to set up iLet Setup (Level 1) your iLet Device for therapy. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 89 BG before the first timer runs Soon (Level 3) out to continue dosing. Dosing Medium Dosing has stopped. Connect a CGM or Stopped (Level 3) enter a BG to resume dosing. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 90 Device. Contact support and switch to alternative iLet Medium therapy as advised by your healthcare Malfunction (Level 4) provider. iLet Bionic Pancreas System User Guide | Responding to Alerts...
Page 91: Troubleshooting
6.1 Always Have an Emergency Kit CAUTION: Always have an alternative method of administering insulin either a vial and syringe or insulin pen. Because your iLet Device uses only rapid-acting insulin, you will not have any long- acting insulin in your body.
Page 92: Verify Proper Functionality
6.2.1 Troubleshooting Device Power If your iLet Device is not on, place it on the iLet Charge. If your iLet Device remains off while on the iLet Charge, check your power supply to ensure that it is connected correctly and ensure that the iLet Device is sitting on the iLet Charge correctly (See Section 2.3.1 Charging Your...
Page 93: Care Information
Always wash your hands after handling used components and accessories. • Check your iLet Device and iLet Device's alerts at least once a day to make sure that it is working properly.
Page 94 Cleaning Your iLet Device • Use a soft towel to dry your iLet Device. Wipe the outside of the Dexcom transmitter with a damp lint-free cloth or isopropyl alcohol wipe between uses. Refer to your Dexcom User Manual for additional instructions.
Page 95: Clinical Performance
8.2 The Bionic Pancreas Pivotal Trial The goal of the research study was to assess the efficacy and safety of using the iLet System to deliver insulin compared to Standard of Care. The study was done at 16 clinical sites in the US and included 440 participants (275 users 18 years of age and older, and 165 users 6-17 years of age).
Page 96 CGM data for diabetes management. Of the 275 people ≥ 18 enrolled, 221 were randomly assigned to the iLet group and 54 were randomly assigned to the Standard of Care group. People ≥ 18 in the iLet group (n=221) were randomly assigned to use either Novolog or Humalog with the iLet System, whichever they used as part of their usual care (n=107), or Fiasp (n=114).
Page 97 The Bionic Pancreas Pivotal Trial glucose, and the percentage of time the CGM glucose was in the range of 70 – 180 mg/dL. The overall enrolment by age and insulin used in the iLet group are detailed in Figure 1. Overall Study...
Page 98 18.5 to 24.9 n (%) 16 (30%) 32 (28%) 29 (27%) 25.0 to 29.9 n (%) 14 (26%) 41 (36%) 40 (37%) >30.0 n (%) 22 (41%) 40 (35%) 38 (36%) iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 99 * HbA1c missing for 1 iLet-F and 1 SC participant. BMI missing for 1 iLet-F participant. C-Peptide missing for 11 iLet-F participants, 4 SC participants, and 8 iLet-N/H participants. Total daily insulin missing for 1 iLet-F participant.
Page 100 Health Insurance n (%) Private 90 (80%) 40 (75%) Medicare/Medicaid 16 (14%) 8 (15%) Other Government Insurance 6 (5%) 4 (8%) None 0 (0%) 0 (0%) Unknown 2 (2%) 1 (2%) iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 101 Across both groups of participants 6-17 and ≥ 18 years of age, and across the types of insulin used by participants ≥ 18 (the Novolog/Humalog group or the Fiasp group) the baseline- adjusted difference in HbA1c was –0.5% after 13 weeks in the iLet group relative to the Standard of Care group (p<0.001).
Page 102 Standard of Care (n=54) iLet (n=107) In people ≥ 18, the average baseline-adjusted difference in HbA1c was –0.5% in the iLet group using Novolog or Humalog versus the Standard of Care group after 13 weeks. 8.2.2.2 Change in HbA1c after 13 Weeks in People ≥ 18 – iLet System with Fiasp...
Page 103 Standard of Care (n=53) iLet (n=112) In people 6-17 years of age, the average baseline-adjusted difference in HbA1c was –0.5% in the iLet group using Novolog or Humalog versus the Standard of Care group after 13 weeks. 8.2.2.4 Change in HbA1c over 13 Weeks in People ≥ 18 According to Baseline HbA1c –...
Page 104 1.48% 0.51% Values are Mean Baseline Adjusted Difference. The study was not designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by baseline HbA1c. Individual user results may vary from the average values shown here. *n=iLet/ Standard of Care.
Page 105 13w Adjusted -16 (-20, -11) -18 (-22, -14) -15 (-21, -9) Group Difference [<0.001] [<0.001] [<0.001] (95% CI) [p-value] †1 participant dropped immediately after randomization. Participant was not included in this table iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 106 The baseline-adjusted difference in the median percentage of time that CGM glucose levels were less than 54 mg/dL in just the group of people ≥ 18 using the iLet System with Novolog or Humalog compared with the Standard of Care group was 0.02% (an increase of less than one minute per day).
Page 107 Values are average baseline Values are Mean Baseline Adjusted Difference. The study was not designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by baseline HbA1c. Individual user results may vary from the average values shown here. *n=iLet/Standard of Care.
Page 108 Values are average baseline Values are Mean Baseline Adjusted Difference. The study was not designed to evaluate the effect of the iLet Bionic Pancreas in subgroups by baseline HbA1c. Individual user results may vary from the average values shown here. *n=iLet/Standard of Care.
Page 109 Two of the cases of infusion set failure resulted in diabetic ketoacidosis. All CGM-measured hyperglycemic outcomes consistently showed that hyperglycemia occurred less often in the iLet groups than in the Standard of Care groups and that prolonged hyperglycemia events (defined as CGM glucose levels >300 mg/dL for at least 90 minutes during a 120-minute period) occurred significantly less frequently in the iLet groups than in the Standard of Care groups.
Page 110 Other Reportable Adverse 7 / 7 12 / 10 3 / 3 8 / 7 0 / 0 Events * both diabetic ketoacidosis (DKA) events were related to infusion set failures 10 4 iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 111 The Bionic Pancreas Pivotal Trial 8.2.3.1 Device Issues There were 472 device issues reported over 13 weeks of the RCT in the iLet Groups, of which 223 were associated with an Adverse Event. Table 5. Device issues People 6 years of age or People ≥...
Page 112 Total In iLet (Humalog or Novolog) , greater than 1 device issue with AE in 98 participants and without AE in 103 participants. In iLet (Fiasp), greater than 1 device issue with AE in 40 participants and without AE in 49 participants. Not included above is (1) 1 device issue form in iLet (Humalog or Novolog) that should not have been submitted as a device issue for ‘bad insulin’...
Page 113: The Insulin-Only Bionic Pancreas Extension Study
RCT. In the Extension Study, the RCT SC group had the opportunity to use the IO configuration of the iLet BP System for 13 weeks. All participants 6-17 years old (at time of consent for the RCT) used study-provided U-100 Fiasp® PumpCart® (insulin aspart) in a pre- filled 1.6mL cartridge during the Extension Study.
Page 114 • Coefficient of variation 8.3.5 Other Key Outcomes • Psychosocial questionnaires • Insulin metrics • Other HbA1c and CGM metrics Safety outcomes included severe hypoglycemia, diabetic ketoacidosis, and non-serious adverse events. 10 8 iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 115 (two participants were assigned aspart insulin and were therefore excluded from the analysis). In the 6-17 years of age cohort of the extension study which used Fiasp with the iLet System, the study found a decrease in HbA1c from baseline to 13 weeks of 0.56%. There was an increase in TIR from baseline by 12.0% and mean glucose decreased by 18 mg/dL.
Page 116 Hypoglycemic event rate per week 1.60 (1.84) 1.63 (1.29) 0.03 (1.11) − Glucose SD (mg/dL) 76 (13) 65 (9) -10.8 (9.9) − Glucose Coefficient of Variation (%) 41% (5%) 39% (4%) -1.8% (3.9%) − iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 117 The participant was hospitalized and fully recovered. The participant was discontinued due to home circumstances. Aside from the infusion set issue, there was no evidence of a malfunction with the BP. iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 118 >1.5 mmol/L or large/moderate urine ketones; c) either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and d) treatment provided in a health care facility. iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 119: References
Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes. Diabetes Technology and Therapeutics 2022. 24:726-736. DOI: 10. 1 089/ dia.2022.0341. iLet Bionic Pancreas System User Guide | Clinical Performance...
Page 120: Technical Information
CGM stops providing glucose data to the iLet Device, BG-run mode will serve to continue a safe level of insulin delivery, but it will not provide the same level of glucose control as the iLet Device with CGM. BG-run use should be temporary and always for the shortest duration possible with the goal to resume CGM-guided iLet System insulin dosing as soon as possible.
Page 121 When an occlusion occurs during a Meal Announcement, the remainder of the dose is not delivered. The amount of the dose that was partially delivered is used by the iLet Dosing Decision Software in future dose calculations.
Page 122 The iLet Dosing Decision Software will respond with No BG autonomous basal insulin doses even if no CGM or BG value is provided. The iLet Device will also alert the user to enter a BG value. No Delivery, The iLet Dosing Decision Software will respond by...
Page 123 CGM or BG values are below 75 mg/dL. Mode The iLet Dosing Decision Software has additional means of providing dose safety. These are: 1. Insulin doses are globally capped at 30 units. 2. Routine autonomous insulin doses in response to CGM glucose values are limited to 3 units.
Page 124: Ilet System Specifications (Ilet Device, Cgm Sensor, And Cgm Transmitter)
Shock 9.3 iLet Device Specifications The iLet Device and power supply accessories have an expected typical use service life of 4-years, including the internal electrical power source. During the service life of your iLet Device you may need to replace charging accessories or other consumable components. Call customer service for charging issues and to ask for a replacement charger.
Page 125 Flow Rates, Insulin (tested per IEC Min Basal (0. 1 U/hr) 60601-2-24) Bolus Delivery Accuracy at all ± 5% Max (30 U)/Intermediate (5 U)/Min (0.5U) Volumes Insulin (tested per IEC 60601-2-24) iLet Bionic Pancreas System User Guide | Technical Information...
Page 126 Input Volt/Current 5V/2A Output Power 5W (Max) Output Type Qi Inductive Charger Inductive Charging Pad w/USB T511-S Choetech Input Volt/Current 5V/2A, 9V/1.8A Output Power 10W (Max) Output Type Qi Inductive Charger iLet Bionic Pancreas System User Guide | Technical Information...
Page 127: Ilet System Delivery Accuracy
The iLet System delivers insulin in two ways: basal insulin delivery (continuous) and bolus insulin delivery. The following accuracy data was collected on both types of delivery in laboratory studies performed by Beta Bionics. The iLet inset™ I infusion set was used for all the testing performed.
Page 128 Infusion Sets 9.4.1 Basal Delivery To assess basal delivery accuracy, iLet Devices were tested by delivering at minimum (29 devices), intermediate (15 devices), and maximum (15 devices) basal rates (0. 1 , 1.0, and 10.0 units/hr). All devices for minimum basal, intermediate basal and maximum basal were new.
Page 129 [118.62, 121.12] 9.4.2 Bolus Delivery To assess bolus delivery accuracy, 15 iLet Devices were tested by delivering consecutive minimum, intermediate, and maximum bolus volumes (0.5, 5.0, and 30 units). All devices were new, and 15 additional devices had been aged to simulate four years of regular use. Water was used as a substitute for insulin for this testing.
Page 130 Number and Percent (<25%) (25-75%) (75-95%) (95-105%) (105-125%) (125-175%) (175-250% (>250%) of Boluses Within Range 0/375 0/375 8/375 366/375 1/375 0/375 0/375 0/375 (0.0%) (0.0%) (2.1%) (97.6%) (0.3%) (0.0%) (0.0%) (0.0%) iLet Bionic Pancreas System User Guide | Technical Information...
Page 131: Explanation Of Symbols
ISO 15223-1 Ref 5. 1 . 1 Manufacturer ISO 7000-3082 IEC 60601-1 Table D. 1 TYPE BF APPLIED PART IEC 60417-5333 IEC 60601-1 Table D. 1 IEC 60417-5172 CLASS II equipment IEC 60601-1 Table D. 1 iLet Bionic Pancreas System User Guide | Technical Information...
Page 132 Non-Ionizing Radiation IEC 60417-5140 Alternating Current IEC 60417-5032 Sterilized using irradiation ISO 15223-1 Ref 5.2.4 Do not use if package is damaged ISO 15223-1 Ref 5.2.8 Keep dry ISO 15223-1 Ref 5.3.4 iLet Bionic Pancreas System User Guide | Technical Information...
Page 133 Two-sided Storage Humidity Limit ISO 15223-1 Ref 5.3.8 Two-Sided Operating Atmospheric ISO 15223-1 Ref 5.3.9 Pressure Limits Two-sided Operating Temperature ISO 15223-1 Ref 5.3.7 Limits Two-sided Operating Humidity Limits ISO 15223-1 Ref 5.3.8 iLet Bionic Pancreas System User Guide | Technical Information...
Page 134: Electromagnetic Compatibility
Explanation of Symbols 10. Electromagnetic Compatibility The information contained in this section is specific to the iLet Bionic Pancreas System. This section provides reasonable assurance of normal operation. However, it does not guarantee such outcomes under all conditions. If your iLet System must be used near other electrical equipment, it should be observed in this environment to verify normal operation.
Page 135: Electromagnetic Emissions
Electromagnetic Emissions 10.1 Electromagnetic Emissions The iLet System is intended for use in the electromagnetic environment specified below. Always make sure that the iLet System is used in such an environment. Emissions Test Compliance Electromagnetic Environment–Guidance The iLet System uses RF energy only for its internal RF Emissions, function.
Page 136: Electromagnetic Immunity
Electromagnetic Immunity 10.2 Electromagnetic Immunity The iLet System is intended for use in the electromagnetic environment specified below. Always make sure that the iLet System is used in such an environment. Electromagnetic Environment– Immunity Test IEC 60601 Test Level Compliance Level...
Page 137 5240 MHz, 5500 the following symbol: 5240 MHz, 5500 MHz, 5785 MHz: MHz, 5785 MHz: 9 9 V/m @ 217 Hz V/m @ 217 Hz Pulse Pulse modulation modulation iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility...
Page 138 RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the System. iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility...
Page 139: Quality Of Wireless Service And Data Security
10.3 Quality of Wireless Service and Data Security The manufacturer defines the wireless quality of service for the iLet System as the percentage of readings successfully received by the iLet Device, where the iLet Device and the CGM transmitter attempt to communicate every 5 minutes. One of the iLet System essential performance requirement states that the iLet System will not discontinue reporting data or information from the CGM transmitter to the user without notification.
Page 140: Fcc Notice Concerning Interference
For information about when your CGM is offline and related alerts see section 4.3 When Your CGM Sensor is Offline. The iLet Device is expected to receive at least 90% of CGM readings sent by the transmitter while the iLet Device and transmitter are located within 20 feet of each other. Wireless communication is assured unless there is wireless interference caused by other devices in the 2.4GHz band.
Page 141 FCC/IC RF exposure limits for general population. Replacement of POWER SUPPLY CORDS and other parts Call Beta Bionics if any component or accessory of the iLet System needs replacement. iLet Bionic Pancreas System User Guide | Electromagnetic Compatibility...
Page 142: Warranty
“Instructions”) and against defects in materials and workmanship, under normal use. The sole remedy for this warranty is that Beta Bionics will, at its sole discretion, repair the or replace the iLet Bionic Pancreas Device with a new or refurbished iLet Bionic Pancreas Device. Repair or replacement of an iLet Bionic Pancreas Device will not extend the original four (4) year warranty, which will continue to apply.
Page 143: Ilet Cartridge Warranty
This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the iLet Bionic Pancreas Device covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the iLet Bionic Pancreas Device and does not apply to other products, accessories, to any third party pre-filled insulin cartridges, or CGM sensors or transmitters.
Page 144: Ilet Infusion Set Warranty
This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the Beta Bionics Cartridge covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the Beta Bionics Cartridge and does not apply to other products, accessories, any third party pre-filled insulin cartridges, or CGM sensors or transmitters.
Page 145: Ilet Connect Warranty
This warranty is valid only in the United States. Beta Bionics, Inc. (“Beta Bionics”) warrants that the Beta Bionics’ Luer adapters for one (1) use during the period of three (3) days after the individual Luer adapter sterile package has been opened, not to exceed beyond the expiration date of the Luer adapter, to the initial purchaser (“original end use purchaser”) shall meet the...
Page 146 Luer adapter by any person or entity other than Beta Bionics; damage is caused by use of the Luer adapter with any non-Beta Bionics insulin cartridge; damage results from an event or accident beyond the control of Beta Bionics; or damage results from negligence or improper use, including but not limited to improper storage or physical abuse such as dropping or otherwise.
Page 147: Returned Goods Warranty
Connect Warranty For product returns, please reference https://www.betabionics.com/support/. iLet Bionic Pancreas System User Guide | Warranty...
Page 148 Connect Warranty Page intentionally left blank iLet Bionic Pancreas System User Guide | Warranty...
Page 149 Connect Warranty Page intentionally left blank iLet Bionic Pancreas System User Guide | Warranty 14 3...
Page 150 Beta Bionics. © 2023 Beta Bionics, Inc. Beta Bionics® and iLet® are registered trademarks of Beta Bionics, Inc. Bionic Pancreas™ and iLet Bionic Pancreas™ are common law trademarks of Beta Bionics, Inc. All rights reserved. All other trademarks are the property of their respective owners.

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