21 About Automated Mode Automated insulin delivery Automated insulin delivery changes as your CGM value and trend change. The table below describes how CGM trend affects your automated insulin delivery in Automated Mode: Automated insulin delivery depends on your baseline adaptive basal rate. This rate is based on your past insulin usage and adapts with each Pod change. The System works to keep CGM values at your specified Target Glucose (110-150 mg/dL).
About Automated Mode 21 Consult with your healthcare provider before making any changes in your Target Glucose. See "Omnipod 5 Clinical Studies" on page 309 for clinical study information at each Target Glucose. SmartBolus Calculator settings can also be adjusted including Insulin-toCarbohydrate ratio, Correction Factor, Correct Above, Reverse Correction and Duration of Insulin Action. These all affect the bolus amounts you deliver during both Manual Mode and Automated Mode.
21 About Automated Mode 21.3. Bolus Settings and Importance of a Bolus In Automated Mode, the Omnipod 5 System automatically delivers insulin every 5 minutes. However, you still need to deliver a bolus dose for meals. For information on how to deliver a bolus, see "Section 3: SmartBolus Calculator" on page 225. When delivering a bolus, it is recommended to: • Tap USE CGM to use your CGM value in the SmartBolus Calculator.
About Automated Mode 21 21.5. About Automated Mode: Limited Warning: ALWAYS be aware of your current CGM value, trust how your body feels, and do not ignore symptoms of high and low glucose. Even though insulin delivery adjusts automatically in Automated Mode with the goal of bringing your glucose level to your defined Target Glucose, severe hypoglycemia or hyperglycemia may still occur.
21 About Automated Mode Note: Automated Mode: Limited state can occur due to a loss of communication between the CGM and Pod. It is possible that your Dexcom G6 app is still receiving CGM values. Open your Dexcom G6 app to check.
CHAPTER 22 Switching Between Manual Mode and Automated Mode Contents 22.1. Switching from Manual Mode to Automated Mode. . . . . . . . . . . . . . 298 Before you begin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 298 To switch to Automated Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 299 22.2.
22 Switching Between Manual Mode and Automated Mode 22.1. Switching from Manual Mode to Automated Mode Warning: ALWAYS be aware of your current CGM value, trust how your body feels, and do not ignore symptoms of high and low glucose. Even though insulin delivery adjusts automatically in Automated Mode with the goal of bringing your glucose level to your defined Target Glucose, severe hypoglycemia or hyperglycemia may still occur.
Switching Between Manual Mode and Automated Mode 22 To switch to Automated Mode To switch from Manual Mode to Automated Mode: 1. From the Home screen, tap Menu button ( ) > Switch Mode. Note: If the screen displays a red circle with an exclamation point and SWITCH TO AUTOMATED is disabled (grayed out), take the corrective action described on the screen before you try again. 2. Tap SWITCH .
22 Switching Between Manual Mode and Automated Mode 22.2. Switching from Automated Mode to Manual Mode When you switch from using Automated Mode to using Manual Mode, basal insulin will be delivered based on the Basal Program scheduled for the current time. If the CGM System is connected, you will still be able to view these values and use them in the SmartBolus Calculator while in Manual Mode. Before you begin, do the following: ¾ Cancel the Activity feature, if it is enabled. See "23.3.
CHAPTER 23 Activity Feature Contents 23.1. About the Activity Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302 23.2. Starting the Activity Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303 23.3. Canceling the Activity Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23 Activity Feature 23.1. About the Activity Feature Warning: ALWAYS monitor for symptoms of hypoglycemia while the Activity feature is enabled. Hypoglycemia can still occur when using the Activity feature. Follow your healthcare provider’s advice on hypoglycemia avoidance and treatment. If untreated, hypoglycemia can lead to seizure, loss of consciousness or death. While in Automated Mode, you cannot start a temp basal or manually pause insulin delivery.
Activity Feature 23 23.2. Starting the Activity Feature Before you begin, do the following: ¾ Switch to Automated Mode if currently using Manual Mode. See "22.1. Switching from Manual Mode to Automated Mode" on page 298. To enable Activity: 1. Navigate to: Menu button ( ) > Activity 2. Tap the Duration field and select the Activity feature duration. 3. Tap CONFIRM. 4. From the Confirmation screen, tap START. The INSULIN tab changes to a green ACTIVITY tab when the Activity feature is enabled. 23.3.
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CHAPTER 24 Automated Mode Alarms Contents 24.1. Advisory Alarm List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306 Automated Delivery Restriction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 306 Missing CGM Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24 Automated Mode Alarms 24.1. Advisory Alarm List Advisory alarms inform you of a situation that needs your attention in the near future. Automated Delivery Restriction Only occurs in Automated Mode. Omnipod 5 App Screens: Lock Screen: Cause Tone (Pod) Vibration/Tone (Controller or smartphone) 306 Insulin was either paused for too long or at maximum delivery for too long while the Omnipod 5 System was in Automated Mode.
Automated Mode Alarms 24 What to do 1. Tap NEXT to see the next screen. 2. Use a BG meter to confirm your blood glucose. • If low confirmed, consider treatment. • If high confirmed, check infusion (Pod) site and ketones. • If your CGM value is not what you expected, you may need to calibrate or replace your Dexcom G6 sensor. 3. Tap NEXT after you confirm your blood glucose. 4. Tap SWITCH TO MANUAL MODE, then stay in Manual Mode for at least five minutes.
24 Automated Mode Alarms Missing CGM Values Only occurs in Automated Mode. Screen Alert Omnipod 5 App: Description Why it occurs: The Pod has not received CGM values for more than one hour. The system will continue to operate in Automated Mode: Limited state until CGM values are received or until you switch to Manual Mode.
CHAPTER 25 Omnipod 5 Clinical Studies The goal of the pivotal study of the Omnipod 5 System was to assess the safety and efficacy of the system. This single-arm, multicenter, prospective study enrolled 112 children (6 to 13.9 years) and 128 adolescents and adults (14 to 70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of the Omnipod 5 System use in Automated Mode. The primary analysis consisted of A1C and sensor glucose time in range (70-180 mg/dL) results.
25 Overview of Omnipod 5 System Pivotal Clinical Study Demographics Baseline characteristics including demographics of the subjects at the start of the 3-month Omnipod 5 treatment phase are provided in the table below. Baseline Characteristics at Omnipod 5 Treatment Phase Start (N=240) Children Adolescents & Adults (6 to 13.9 years) (14 to 70 years) 112 128 Age (years) ± SD 10.3 ± 2.2 36.9 ± 13.9 Duration of diabetes (years) 4.7 ± 2.6 17.9 ± 11.6 7.67% ± 0.95% 7.16% ± 0.86% 0.85 ± 0.24 0.
Overview of Omnipod 5 System Pivotal Clinical Study 25 Glycemic Results The tables below include information on the primary and secondary glycemic results from the standard therapy phase compared to the 3-month Omnipod 5 System treatment phase. The primary results of the study included change in average A1C% and % time in range (70-180mg/dL). Adolescents, adults, and children experienced improvements in overall A1C and time in range after 3 months of Omnipod 5 System use.
25 Overview of Omnipod 5 System Pivotal Clinical Study Glycemic Results Overall (24 hours) Children (6 to 13.9 years) (n=112) Adolescents & Adults (14 to 70 years) (n=128) Characteristic Standard Therapy Omnipod 5 Change Standard Therapy Omnipod 5 Change Avg A1C% (std dev) 7.67% (0.95%) 6.99% (0.63%) -0.71%* 7.16% (0.86%) 6.78% (0.68%) -0.38%* Avg % time 70-180mg/dL 52.5% (std dev) (15.6%) 68.0% (8.1%) 15.6%* 64.7% (16.6%) 73.9% (11.0%) 9.
Overview of Omnipod 5 System Pivotal Clinical Study 25 Glycemic Results Overnight (12:00AM to 6:00AM) Children (6 to 13.9 years) (n=112) Adolescents & Adults (14 to 70 years) (n=128) Standard Therapy Omnipod 5 Change Standard Therapy Omnipod 5 Change Avg % time 70180mg/dL (std dev) 55.3% (19.0%) 78.1% (10.8%) 22.9%* 64.3% (19.5%) 78.1% (13.9%) 13.
25 Overview of Omnipod 5 System Pivotal Clinical Study Change in A1C Analyzed by Baseline A1C The table below provides information on the average change in A1C% from baseline to the end of the 3-month Omnipod 5 System treatment phase analyzed by baseline A1C% in children (6 to 13.9 years) and adolescents and adults (14 to 70 years). Adolescents, adults, and children experienced a reduction in A1C after 3 months of Omnipod 5 System use regardless of baseline A1C < 8% or ≥ 8% category.
Overview of Omnipod 5 System Pivotal Clinical Study 25 Glycemic Results by Baseline Treatment The table below provides information on the average glycemic results at baseline (or during standard therapy phase) and the 3-month Omnipod 5 System treatment phase analyzed by baseline treatment (standard therapy). Standard therapy consisted of multiple daily insulin injections (MDI) or insulin pump use.
Overview of Omnipod 5 System Pivotal Clinical Study Insulin Requirements The table below provides information on the average insulin requirements during the standard therapy phase and the 3-month Omnipod 5 System phase. Total daily insulin requirements increased in children and decreased slightly in adolescents and adults. Characteristic Avg total daily insulin, U/kg (std dev) Avg total daily basal insulin, U/kg (std dev) Children (6 to 13.
Overview of Omnipod 5 System Pivotal Clinical Study 25 Omnipod 5 System Use The table below provides information on the average % of time study subjects used the Omnipod 5 System in Automated Mode. Percent Time Spent in Automated Mode % Time in Automated Mode (std dev) Children (6 to 13.9 years) n=112 Adolescents & Adults (14 to 70 years) n=128 95.2% (4.0%) 94.8% (6.
25 Overview of Omnipod 5 System Pivotal Clinical Study Glycemic Results at Target Glucose Settings in Pivotal Study The tables below provide information on the glycemic results at various selfselected Target Glucose settings during the 3-month Omnipod 5 System phase of the pivotal study. Of the customizable Glucose targets, the most selected was 110 mg/dL. Overall (24 hours) Glycemic Results at Target Glucose Settings in Children (6 to 13.
Overview of Omnipod 5 System Pivotal Clinical Study 25 Overall (24 hours) Glycemic Results at Target Glucose Settings in Adolescents and Adults (14 to 70 years) from Pivotal Study Characteristic 110 mg/dL Target Glucose (n=121) 120 mg/dL Target Glucose (n=54) 130 mg/dL Target Glucose* (n=9) Avg % time 70-180 mg/dL (std dev) 75.6% (9.9%) 73.4% (12.1%) 63.6% (25.9%) Avg sensor glucose, mg/dL (std dev) 151 (15) 156 (18) 172 (33) Median % <54 mg/dL (Q1, Q3) 0.16% (0.05, 0.26) 0.11% (0.00, 0.
25 Overview of Omnipod 5 System Pivotal Clinical Study Omnipod 5 System Pre-Pivotal Glycemic Results at Target Glucose Settings Glycemic Results at Target Glucose Settings in Pre-Pivotal Study The goal of the pre-pivotal study of the Omnipod 5 System was to assess the safety and efficacy of the system. This single-arm, multicenter, prospective study enrolled 18 children (6 to 13.9 years) and 18 adults (14 to 70 years) with type 1 diabetes.
Overview of Omnipod 5 System Pivotal Clinical Study 25 Overall (24 hours) Glycemic Results at Target Glucose Settings in Adolescents and Adults (14 to 70 years) from Pre-Pivotal Study Characteristic 110mg/dL 120mg/dL 130mg/dL 140mg/dL 150mg/dL Target Target Target Target Target Glucose Glucose Glucose Glucose Glucose (n=12) (n=7) (n=18)a (n=18) (n=18)b Avg % time 70-180 mg/dL (std dev) 72.5% (9.4%) 70.9% (11.3%) 75.1% (11.6%) 67.6% (9.2%) 63.7% (7.8%) Avg sensor glucose, mg/dL (std dev) 153.8 (14.
25 Overview of Omnipod 5 System Pivotal Clinical Study CGM-Informed SmartBolus Calculator Clinical Study A study was conducted on 25 participants with type 1 diabetes aged 6-70 years to assess the Omnipod 5 CGM-informed SmartBolus Calculator. During Phase 1, participants used the Omnipod 5 system in Manual Mode for the first 7 days without a connected CGM (standard SmartBolus Calculator).
ADDITIONAL INFORMATION 26 Frequently Asked Questions and Troubleshooting Appendix
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CHAPTER 26 Frequently Asked Questions and Troubleshooting .Contents 26.1. Omnipod 5 Pump FAQs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326 Pod Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326 Finding Out How Much Insulin Was Delivered. . . . . . . . . . . . . . . . . . . . . . . . . .
26 Frequently Asked Questions and Troubleshooting 26.1. Omnipod 5 Pump FAQs The following topics have been frequently asked during the use of Omnipod 5, and the main causes and recommended actions are listed below. Pod Issues Issue Possible Cause During Pod activation, did not hear the 2 beep confirmation after filling the Pod with insulin The adhesive around the Pod keeps lifting from the skin Pod not filled with at Make sure the Pod is filled with least 85 units of insulin.
Frequently Asked Questions and Troubleshooting 26 Finding Out How Much Insulin Was Delivered Issue What you can do Where to see how much insulin is delivered while in Automated Mode The CGM graph will show you the latest CGM value received by the Pod and what mode of insulin delivery the system is in. (To see the graph, tap VIEW from the lower right part of the Home screen.) The graph will also show when your last boluses were delivered.
26 Frequently Asked Questions and Troubleshooting Controller Issues Issue Possible Cause What you can do Controller unable to power on or screen is unreadable Device error Try restarting the Controller by holding down the Power button for 10 seconds. The Controller should restart and regain communication successfully. If the issue does not resolve, call Insulet Customer Care at 1-800-591-3455. Screen turns black Screen Time-Out (times out) too setting needs soon adjustment.
Frequently Asked Questions and Troubleshooting 26 Caution: DO NOT reset the Omnipod 5 App or clear the app data before checking with your healthcare provider. This will erase all of your settings, Adaptive Basal Rate, and history, and require you to change your active Pod. Before resetting or clearing app data, make sure you have a current record of your settings and a new Pod with supplies to use when restarting the app.
26 Frequently Asked Questions and Troubleshooting Issue Possible Cause What you can do Received an “Omnipod 5 failed to start” message when opening the Omnipod 5 App Not receiving important updates about insulin therapy Your Omnipod 5 App encountered into a problem starting up. 1. Close the Omnipod 5 App and reopen the App You force stopped the Omnipod 5 App. Force stopping is not the same as locking your screen or putting your App to sleep. It means stopping the App from running in the background.
Frequently Asked Questions and Troubleshooting 26 Issue Possible Cause What you can do Opening the Omnipod 5 App restarts the setup process You cleared App data for the Omnipod 5 App. This causes you to lose all your settings and insulin history. If you clear data for the Omnipod 5 App, your current Pod will still be delivering insulin, but you won't be able to manage it with your Omnipod 5 App. 1. Remove the current Pod in order to stop receiving insulin. 2.
26 Frequently Asked Questions and Troubleshooting 26.2. SmartBolus Calculator FAQs Issue Possible Cause What you can do With carbs entered and CGM value available, the SmartBolus Calculator recommends no bolus or 0 insulin. You have already received a lot of insulin (your IOB is high), and your CGM trend is falling. You can remove the CGM value so that the calculator only suggests a bolus amount for the carbs entered.
Frequently Asked Questions and Troubleshooting 26 26.3. CGM FAQs Issue Possible Cause What you can do Activated a Pod and cannot see CGM values in the Omnipod 5 App Problem with the CGM. Check your Dexcom G6 app and if you do not see CGM values, then follow instructions there. CGM transmitter serial number is not entered into the Omnipod 5 App. 1. Go to: Menu button ( ) > Settings > CGM Transmitter. You are using the Dexcom G6 receiver. 1. Use the Dexcom G6 app on your smartphone.
26 Frequently Asked Questions and Troubleshooting Issue Possible Cause What you can do CGM values no longer show up in the Omnipod 5 App. Instead, there are dashed lines. The Dexcom G6 app does not show a problem. The most likely reason for this to happen is an interruption in communication between the CGM and the Pod. To minimize the risk of interruption, make sure your CGM and Pod are worn on the same side of the body. Wireless communications do not travel well through the body.
Frequently Asked Questions and Troubleshooting 26 High Glucose Issues Issue Possible Cause What you can do After using the system for a couple of weeks, CGM values are running high after breakfast. The Insulin-to-Carb ratio is the same. One of the benefits of automated insulin delivery is the greater ability to stay closer to your Target Glucose overnight. What this often means is that prior to breakfast, there is less insulin in your body compared to Manual Mode.
26 Frequently Asked Questions and Troubleshooting Issue Possible Cause What you can do After using the system in Automated Mode for a few weeks, CGM values have been running high. Your Target Glucose may need to be adjusted. In Automated Mode, Target Glucose is the main setting that you can control to adjust automated insulin delivery. Check your Target Glucose here: Other SmartBolus Calculator settings may need to be adjusted.
Frequently Asked Questions and Troubleshooting 26 Issue Possible Cause What you can do CGM values have been running high over several days. Although the system is able to automate insulin delivery, your body’s insulin needs can change daily. This means that every day with diabetes is different. Think about diet, exercise, Pod insertion site, and change in your body’s needs and how they are affecting your glucose.
26 Frequently Asked Questions and Troubleshooting Following afternoon exercise, CGM values are going low. During exercise, your To reduce the risk of this body is often prone to low low, you can use the Activity glucose. feature. With this feature, the system delivers less insulin and also drives insulin delivery to a target of 150 mg/ dL. It is recommended that you turn this setting ON at least 30-60 minutes before exercise. Exercise with diabetes requires trial and error.
Frequently Asked Questions and Troubleshooting 26 Screen shows Automated Mode: Limited Interruption in communication between the CGM and the Pod. Problem with the CGM Automated Mode may have reached the limits of insulin delivery, either the maximum or the minimum. To minimize the risk of interruption, make sure your Pod and CGM are worn on the same side of the body. Wireless communications do not travel well through the body.
26 Frequently Asked Questions and Troubleshooting Error when sending insulin instructions to the Pod A communication error may occur when the Omnipod 5 App attempts to send insulin delivery instructions to the Pod. If a communication error occurs when the Omnipod 5 App attempts to send an insulin delivery instruction, the Omnipod 5 App offers you different options.
Frequently Asked Questions and Troubleshooting 26 • DEACTIVATE POD: This should not be your first choice. Select this option to deactivate the Pod when CHECK STATUS is unsuccessful. Error when activating a Pod If a communication error occurs during Pod activation, the following options become available: • DISCARD POD: This should not be your first choice. Select this option to stop attempting to use this Pod. • TRY AGAIN: Select this option to attempt to re-establish communication.