7 Delivering a Bolus with the SmartBolus Calculator 17.2. Entering Meal Information To enter carbohydrates, or "carbs," for your meal: 1. On the Home screen, tap the Bolus button ( ). Note: The Bolus screen is only valid for 5 minutes. After 5 minutes, if bolus delivery has not started, you must refresh and reenter new values. 2. Tap the Carbs field. Enter the grams of carbs and tap Done. Note: Consult your healthcare provider about how to calculate the grams of carbs. 3.
Delivering a Bolus with the SmartBolus Calculator 17 To enter a blood glucose reading: 1. Tap the Glucose field. If you have manually entered a blood glucose reading from a meter within the past 10 minutes, that value automatically appears in the Glucose field. If you want the SmartBolus Calculator to use that value, skip the next step. 2. Tap the box in the circle and enter the blood glucose reading. Alternatively, slide the indicator along the circle to enter the blood glucose reading.
17 Delivering a Bolus with the SmartBolus Calculator If the current CGM value is below the defined Minimum Glucose for Calculations setting, you will see a message that the SmartBolus Calculator is disabled. If the CGM value displays "HIGH", the SmartBolus Calculator is temporarily disabled. Note: If your Omnipod 5 System does not have a valid CGM value or trend at the time you open the SmartBolus Calculator, the USE CGM option is disabled.
Delivering a Bolus with the SmartBolus Calculator 17 17.5. Adjustments to Your Calculation A suggested meal bolus that is calculated using your Insulin to Carb (IC) Ratio may be further adjusted for other values entered into and used by the SmartBolus Calculator, including: blood glucose readings, CGM value and trend, and/or IOB.
17 Delivering a Bolus with the SmartBolus Calculator 6. Review the bolus details on the Confirm Bolus screen. Grams of carbs Blood glucose or CGM value The total bolus includes any IOB adjustments and any adjustments you made to the calculated bolus. Adjusted for IOB of x U means the SmartBolus Calculator took IOB into account. 7. Tap START to begin the bolus. The Home screen tracks the delivery of an immediate or extended bolus (see "16.3. Tracking the Progress of a Bolus" on page 234). 17.7.
Delivering a Bolus with the SmartBolus Calculator 17 CLOSE when done. See "SmartBolus Calculator Equations" on page 263 for details. 3. Tap EXTEND BOLUS. 4. Tap the Now field and enter the percentage of the bolus to be delivered immediately. Alternatively, tap the Extended field and enter the percentage to be extended. The number of units to be delivered now and over the extended period appear below the percentage (%). Note: You can extend only the meal portion of the bolus.
17 Delivering a Bolus with the SmartBolus Calculator 17.8. Bolus Settings Warning: DO NOT start to use your system or change your settings without adequate training and guidance from your healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.
Delivering a Bolus with the SmartBolus Calculator 17 Omnipod 5 Setting and How to Enter the Range Setting Maximum Bolus Enter in Omnipod 5 App Settings or during 0.05 – 30 U First Time Setup (0.05 U increments) Extended Bolus Enter in Omnipod 5 (Manual Mode only) App Settings or during First Time Setup ON/OFF Impacts to Suggested Bolus Calculations Limits amount of single bolus dose. Target Glucose & Correct Above Increase in setting value decreases amount of suggested bolus dose.
17 Delivering a Bolus with the SmartBolus Calculator Omnipod 5 Setting and Range Duration of Insulin Action 2 – 6 hours How to Enter the Setting Enter in Omnipod 5 App Settings or during First Time Setup (0.5 hour increments) Impacts to Suggested Bolus Calculations Increase in setting value may decrease amount of suggested bolus dose for longer periods. Note: The Extended Bolus feature can only be used in Manual Mode. All other therapy settings are used similarly in both Manual and Automated Modes.
Delivering a Bolus with the SmartBolus Calculator 17 calculates a correction bolus if your glucose is above your Correct Above setting. In Automated Mode, the Omnipod 5 System will adjust your automated insulin delivery with the goal of bringing you to your Target Glucose. To edit Target Glucose or Correct Above values: 1. Navigate to: Menu button ( Correct Above. ) > Settings > Bolus > Target Glucose & 2. Tap NEXT. 3. To edit a segment, tap the row containing the segment you want to edit. a.
17 Delivering a Bolus with the SmartBolus Calculator 4. Repeat the previous step as needed for the remaining segments. 5. After confirming that all segments are correct, tap SAVE. Note: You can add and delete segments by editing the existing segments. Correction Factor The SmartBolus Calculator uses your Correction Factor to calculate a correction bolus when your glucose is above your Correct Above setting. See "Target Glucose and Correct Above" on page 250. To edit this value: 1.
CHAPTER 18 Understanding SmartBolus Calculator Calculations Contents 18.1. The SmartBolus Calculator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254 SmartBolus Calculator Boluses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254 Extended boluses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 Understanding SmartBolus Calculator Calculations 18.1. The SmartBolus Calculator Your Omnipod 5 System's SmartBolus Calculator can do a lot of the work of calculating a bolus for you. The SmartBolus Calculator uses your personal settings and also takes into account any insulin that remains (referred to as insulin on board or IOB) from automated insulin delivery and from recent boluses.
Understanding SmartBolus Calculator Calculations 18 When the SmartBolus Calculator Does Not Work The SmartBolus Calculator does not work when it is disabled or when there is no Pod communication. Being "disabled" means that the SmartBolus Calculator is temporarily unable to calculate a suggested bolus. Your Omnipod 5 System may disable the SmartBolus Calculator in a few situations.
18 Understanding SmartBolus Calculator Calculations • Reverse Correction, if it is enabled. Note: In both Automated and Manual Mode, if using a CGM values and trend in the Calculator, the SmartBolus Calculator may reduce the suggested insulin dose, even if your reverse correction setting is OFF.
Understanding SmartBolus Calculator Calculations 18 Reverse Correction If the Reverse Correction setting is turned ON and your glucose is below your Target Glucose, the SmartBolus Calculator reduces the meal bolus. This allows part of the meal to be used to raise the glucose towards the Target Glucose. If the Reverse Correction setting is turned OFF, the SmartBolus Calculator suggests the full meal bolus even if your glucose is below your Target Glucose.
18 Understanding SmartBolus Calculator Calculations Insulin to Carb Ratio 1-150 grams To calculate total bolus volume. Duration of Insulin Action 2-6 hours To calculate total bolus volume. Meal IOB Portion 0-X Units To calculate total bolus volume. Target Glucose 110-150 mg/dL To calculate total bolus volume. Target Glucose 110-150 mg/dL To calculate total bolus volume. Correction IOB Portion 0-X Units To calculate total bolus volume. 40-400 mg/dL To calculate total bolus volume.
Understanding SmartBolus Calculator Calculations 18 Boundaries of the SmartBolus Calculator suggestions The following figure shows the boundaries between the types of calculations performed by the SmartBolus Calculator depending on your glucose.
18 Understanding SmartBolus Calculator Calculations Considerations about SmartBolus Calculator Recommendations Keep the following in mind when using the SmartBolus Calculator and reviewing its recommendations: • The SmartBolus Calculator uses your SmartBolus Calculator settings for the time you are requesting a bolus (See "SmartBolus Calculator Settings" on page 250). • The SmartBolus Calculator refreshes values every 5 minutes.
Understanding SmartBolus Calculator Calculations 18 SmartBolus Calculator Time Out Time Zones The SmartBolus Calculator considers the values you input for a given bolus calculation valid for up to 5 minutes from initial entry of the value into the SmartBolus Calculator. If 5 minutes or more have elapsed, you will be notified that you must refresh the SmartBolus Calculator and input the values again.
18 Understanding SmartBolus Calculator Calculations In the Omnipod 5 System, the correction IOB can also change depending on the SmartAdjust technology calculations. It can increase or decrease automatically. Insulin on board (IOB) calculations Duration of Insulin Action – time since previous bolus x previous bolus Duration of Insulin Action IOB from a previous correction bolus is called a “correction IOB.” IOB from a previous meal bolus is called a “meal IOB.
Understanding SmartBolus Calculator Calculations 18 SmartBolus Calculator Equations The SmartBolus Calculator first calculates a preliminary correction and meal bolus. It adjusts these values for IOB, if necessary. It then suggests a final total bolus that includes the adjusted correction bolus and meal bolus. Note: Your adjustments from the CGM trend can add or subtract insulin from the correction and/or the meal portion.
18 Understanding SmartBolus Calculator Calculations SmartBolus Calculator Rules The SmartBolus Calculator applies the following rules to the suggested bolus doses: Rule Rounding Factors that influence the size of your bolus Detail Boluses will always be rounded down to the nearest 0.05 U and will never be below 0 U. IOB will always be rounded up to the nearest 0.05 U and will never be below 0 U.
Understanding SmartBolus Calculator Calculations 18 Overview of the Bolus Calculations Screen You can tap VIEW BOLUS CALCULATIONS from the Insulin & BG history screen or tap CALCULATIONS from the SmartBolus Calculator screen if you want to view bolus calculation details. When a CGM value and trend are used for a bolus, the SmartBolus Calculator will not only consider the value but may also adjust the bolus amount for the trend. You will see these adjustments labeled in the Bolus Calculations Screen.
18 Understanding SmartBolus Calculator Calculations 18.2. SmartBolus Calculator Examples Example 1 Eating 50 g carbs, and 0.6 U meal IOB and 0.5 U correction IOB from previous meal and correction boluses. CGM is not available and a blood glucose reading is not entered. Correction Bolus -- U BG = N/A, Target Glucose = N/A Correction Factor = N/A Meal IOB adjustment Meal IOB = 0.
Understanding SmartBolus Calculator Calculations 18 Example 2 Eating 30 g carbs, no meal or correction IOB. Used CGM value of 180 mg/dL, with a rising trend. Correction Bolus 1.2 U CGM = 180, Target Glucose = 130 Correction Factor = 50 (180-130) / 50 = 1 U Your glucose is 180 mg/dL which is 50 mg/ dL over your target. Because your correction factor is 50, the initial correction bolus is 1 U.
18 Understanding SmartBolus Calculator Calculations Example 3 No carbs entered, used CGM of 180 mg/dL with decreasing trend. There is 0.8 U meal IOB and 0.5 U correction IOB from the previous meal and correction boluses. Correction Bolus 0U CGM = 180, Target Glucose = 130 Correction Factor = 50 (180 -130) / 50 = 1 U Your glucose is 180 mg/dL, which is 50 mg/dL over target. Because your correction factor is 50, the initial correction bolus is 1 U. Meal IOB adjustment Meal IOB = 0.8 U 1 U - 0.8 U = 0.
USING A CGM WITH OMNIPOD 5 CGM Important Safety Information 19 About the Dexcom G6 20 Connecting Dexcom G6 CGM to the Pod
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CGM Important Safety Information CGM Warnings 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.
Important Safety Information of the procedure room. Exposure to X-ray, MRI, or CT, treatment can damage these components. Check with your healthcare provider on Pod removal guidelines. Warning: DO NOT use Omnipod 5 System if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. Your Dexcom G6 CGM values may be falsely elevated and result in over-delivery of insulin that can result in severe hypoglycemia.
CHAPTER 19 About the Dexcom G6 Contents 19.1. CGM Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274 19.2. CGM Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275 Adult placement examples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275 Pediatric placement examples. . . . . . . . . . . . . . .
19 About the Dexcom G6 19.1. CGM Overview 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.
About the Dexcom G6 19 Note: The Omnipod 5 System also alerts you when your CGM values are at or below 55 mg/dL. • Always ensure the transmitter serial number entered in the Dexcom G6 and Omnipod 5 Apps match the transmitter on your body. 19.2. CGM Placement The Bluetooth connection between the CGM and the Pod is optimal when the signal does not pass through the body. Keeping both devices at least 3 inches (7.62 cm) apart and within line of sight allows for consistent CGM communication with the Pod.
19 About the Dexcom G6 Pediatric placement examples Pod Pod CGM CGM Note: Consult the Dexcom G6 CGM System User Guide for more information on approved CGM placement locations. 19.3. Using the Dexcom G6 with Omnipod 5 When using Omnipod 5 System with the Dexcom G6 CGM System, you need to use the Dexcom G6 app to control your CGM. Caution: You cannot use the Dexcom G6 receiver with the Omnipod 5 System because the Omnipod 5 System is compatible only with the G6 app on a smartphone.
About the Dexcom G6 19 19.4. CGM Values CGM values are displayed on the DASHBOARD. The DASHBOARD also displays a CGM trend arrow to indicate whether CGM values are trending up, down, or holding steady. In Automated Mode, the system takes your CGM trend into account every 5 minutes when making automated insulin delivery decisions. In Manual Mode and Automated Mode, the CGM value and trend can be used in the SmartBolus Calculator.
19 About the Dexcom G6 Note: This Alarm will occur again if another CGM value of 55 mg/dL or lower is received after the initial Advisory Alarm was acknowledged. Note: This Advisory Alarm will only stop repeating after a glucose value of 56 mg/ dL or greater is received. You may silence this Advisory Alarm for 30 minutes by acknowledging the on-screen message. Note: Use a BG meter to confirm your glucose. Treat low glucose as needed.
About the Dexcom G6 19 19.6. Communication Messages The DASHBOARD displays the following communication messages: • CONNECTING TRANSMITTER: Occurs after you have entered a transmitter serial number and the Pod is attempting to connect with the transmitter. • WAITING FOR DEXCOM SETUP: When the transmitter is connected but CGM values are unavailable because the Dexcom G6 is in sensor warm-up or requires calibration. See the Dexcom G6 app for details. No action is required within the Omnipod 5 App.
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CHAPTER 20 Connecting Dexcom G6 CGM to the Pod Contents 20.1. About Connecting Dexcom G6 to the Pod . . . . . . . . . . . . . . . . . . . . . . . 282 20.2. Connecting the Dexcom G6 during Initial Pod Setup . . . . . . . . . . . . 282 20.3. Connecting the Dexcom G6 Transmitter. . . . . . . . . . . . . . . . . . . . . . . . . 283 20.4. Disconnecting the CGM from the Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . .
20 Connecting Dexcom G6 CGM to the Pod 20.1. About Connecting Dexcom G6 to the Pod The Omnipod 5 System is designed to work with the Dexcom G6 CGM. To use the Dexcom G6 CGM with the Omnipod 5 System, you will need to obtain the Dexcom G6 sensor and transmitter, Dexcom G6 User Guide, and download the Dexcom G6 app on your personal smartphone. Before you can view and use CGM values in the in the Omnipod 5 System, you must first set up the Omnipod 5 System to allow the Pod to communicate with the CGM.
Connecting Dexcom G6 CGM to the Pod 20 20.3. Connecting the Dexcom G6 Transmitter Warning: ALWAYS confirm the Dexcom G6 Transmitter serial number you save in the Omnipod 5 App matches the one you are wearing. In cases where more than one person in the household uses the Dexcom G6 CGM, mismatching transmitter serial numbers could result in over-delivery or underdelivery of insulin, which can lead to hypoglycemia and hyperglycemia.
20 Connecting Dexcom G6 CGM to the Pod If you do not have an active Pod or you are changing your Pod, the transmitter serial number will be saved and sent to the next Pod that is activated. 20.4. Disconnecting the CGM from the Pod To stop the Pod from communicating with the CGM, delete the serial number. If you delete the serial number, you will no longer be able to enter Automated Mode until a new transmitter serial number is added. To delete the serial number: 1.
AUTOMATED MODE 21 About Automated Mode 22 Switching Between Manual Mode and Automated Mode 23 Activity Feature 24 Automated Mode Alarms 25 Omnipod 5 System Clinical Studies
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Automated Mode Important Safety Information Automated Mode Important Safety Information Automated Mode Warnings Warning: SmartAdjust technology should NOT be used by anyone under the age of 6 years old. SmartAdjust technology should also NOT be used in people who require less than 6 units of insulin per day as the safety of the technology has not been evaluated in this population. Warning: DO NOT use SmartAdjust technology in pregnant women, critically ill patients, and those on dialysis.
Important Safety Information can lead to seizure, loss of consciousness or death. Warning: Do NOT use Omnipod 5 System if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. Your Dexcom G6 CGM readings could be falsely elevated and could result in over-delivery of insulin which can lead to severe hypoglycemia.
CHAPTER 21 About Automated Mode Contents 21.1. About Automated Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290 How insulin is calculated and delivered during Automated Mode. 290 Automated insulin delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292 21.2. About the Dexcom G6 in Automated Mode. . . . . . . . . . . . . . . . . . . . . . 293 21.3. Bolus Settings and Importance of a Bolus . . . . . . . . . . . . . . . . . . . .
21 About Automated Mode 21.1. About Automated Mode Warning: AVOID administering insulin, such as by injection or inhalation, while wearing an active Pod as this could result in hypoglycemia. The Omnipod 5 System cannot track insulin that is administered outside of the system. Consult your healthcare provider about how long to wait after manually administering insulin before you start Automated Mode.
About Automated Mode 21 The System can automatically increase, decrease, or pause insulin delivery. The System can pause automated insulin delivery at any time to protect against hypoglycemia and will always pause when your glucose is below 60 mg/dL. The System can increase insulin delivery by delivering a series of microboluses to respond to elevated glucose.
