Accu-ChekT Bolus Advisor: Clinician Instruction Guide for Setup and Use Table of Contents Introduction and definitions of key terms......................................................................................................3 Section 1: Basic setup..........................................................................................................................................7 This section shows you how to set up the Bolus Advisor for the first time in order to receive basic bolus advice. It then provides step-by-step instructions for calculating a bolus. Introduction Alternative scenarios......................................................................................................................................... 11 Recording bolus insulin delivered without using bolus advice Bolus advice without entering blood glucose value Bolus advice with a hypo blood glucose Bolus advice with low blood glucose Section 2: Additional Bolus Advisor settings...................................................................................... 13 This section covers other settings that can be used to customize the Bolus Advisor, then provides stepby-step instructions for calculating a bolus using some of those settings. Alternative scenarios......................................................................................................................................... 23 How to handle combined adjustments to bolus advice Traveling to a new time zone Appendix.................................................................................................................................................................... 24 Advice Options – Meal Rise, Acting Time, Offset Time and Snack Size 2 Intended Use of the Accu-Chek Bolus Advisor Be sure to complete the Accu-ChekT Bolus Advisor Protocol sheet, which includes required and optional settings for customizing bolus advice for each patient. The Accu-Chek Connect diabetes management app is intended as an aid in the treatment of diabetes. The Accu-Chek Connect diabetes management app provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. ℞ Activation code: 000-0000-000 Accu-ChekT Bolus Advisor Protocol Patient’s name Date of birth Please provide the following settings for your patient. Settings (1–5) are required in the basic setup in order to use the Accu-Chek Bolus Advisor. Additional settings can be adjusted in the Settings/Advisor menu. Space for additional time blocks and other settings is provided on the back of this form. Basic settings 1. Target Range* Default 2. Meal Rise* 70 mg/dL 3. Carb Ratio* 1 U: ________ g** 4. Insulin Sensitivity* 5. Max Bolus* Changes/Comments 70 – 110 mg/dL 1 U: ________ mg/dL 25 U Additional settings 6. Snack Size* 7. Bolus Insulin Name In some countries, before its use, a physician or healthcare professional must prescribe the Accu-Chek Bolus Advisor and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the Accu-Chek Bolus Advisor. 0 g** Generic Bolus (Rapid-acting) 8. Offset Time* 1 hour 9. Acting Time* 4 hours 10. Insulin Increment* The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect diabetes management app, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The Accu-Chek Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Introduction Before you get started: 1U Related settings (go to Settings/Blood Glucose Settings) 11. Hypo Warning Limit* 70 mg/dL† *Definitions: Target Range: Acceptable upper and lower blood glucose level when fasting or before a meal. Meal Rise: Expected rise in glucose levels in response to a meal. Carb Ratio: The amount of insulin necessary to account for a specified amount of carbohydrates. Insulin Sensitivity (Correction factor): The amount of insulin necessary to lower your blood glucose by a specified amount. Max Bolus: The maximum amount of insulin to be delivered at one time. This serves as a safety measure against unintended large boluses by asking user for added confirmation. Snack Size: Eating more than this amount of carbohydrates will trigger a Meal Rise. Offset Time: Length of time after a bolus until a reduction in blood glucose begins. Acting Time: Total length of time the insulin is expected to be effective at lowering blood glucose. Insulin Increment: 0.5 or 1 unit of insulin, depending on the increment of the insulin pen/syringe being used by the patient. Hypo Warning Limit: The setting below which the blood glucose level is considered hypoglycemic. The user is prompted with a recommendation to eat an appropriate amount of carbohydrates. **The default setting for carbs is grams (g). If desired, this can be changed under the Settings/units menu to one of eight other options. † The Hypo Warning Limit default is 70 mg/dL. To change, go to the Settings/Blood Glucose Settings menu. Healthcare provider name (please print) Telephone # Healthcare provider signature Date 3 The mathematical basis for bolus calculations Introduction Below is a list of the most important formulas and principles that bolus advice uses to calculate your bolus. It is difficult to accurately calculate a bolus yourself using these formulas (remembering to include the Acting Time and Offset Time of your most recent boluses). This is why bolus advice is so useful. It will save you a lot of time and avoids the risk of mistakes in your calculations. Meal bolus Carbohydrate intake Insulin Carbohydrate from Carb Ratio (see Definitions) Correction bolus Current blood glucose Currently allowed blood glucose* Insulin Blood glucose** Generally, a correction bolus is calculated only if your current blood glucose value is above the hypo blood glucose warning limit and outside of the Target Range. Additionally, it must be above the currently allowed blood glucose value. Only correction boluses greater than 0 will trigger an Acting Time. 4 *Currently Allowed Blood Glucose Value = The blood glucose value used in the calculation of a correction bolus, taking into account time block settings (Target Range mean value), currently active meals (Meal Rise) and currently acting correction boluses (Active Insulin). **Δ Blood glucose = change in blood glucose as part of insulin sensitivity (correction factor). Term Definition Allowable Range Target Range Acceptable upper and lower blood glucose level when fasting or before a meal. Upper: 100 – 270 mg/dL Lower: 50 – 140 mg/dL Meal Rise Expected rise in glucose levels in response to a meal. 30 – 200 mg/dL Carb Ratio The amount of insulin necessary to account for a specified amount of carbohydrates. 1U:1g – 1U:150g Insulin Sensitivity (Correction factor) The amount of insulin necessary to lower your blood glucose by a specified amount. 1U:5 mg/dL – 1U:400 mg/dL Max Bolus The maximum amount of insulin to be delivered at one time. This serves as a safety measure against unintended large boluses by asking user for added confirmation. 0 – 50 U Snack Size Eating more than this amount of carbohydrates will trigger a Meal Rise. Introduction Definitions for important settings referred to in this instruction guide: 0 to 24 grams 5 Definitions for important settings referred to in this instruction guide: Introduction Term 6 Definition Allowable Range Offset Time Length of time after a bolus until a reduction in blood glucose begins. 0:45 - 8:00 hours Acting Time Total length of time the insulin is expected to be effective at lowering blood glucose. 1:30 - 8:00 hours Insulin Increment 0.5 or 1 unit of insulin, depending on the increment of the insulin pen/syringe being used by the patient. Hypo The setting below which the blood glucose level is considered hypoglycemic. The user is prompted with a recommendation to eat an appropriate amount of carbohydrates. Active Insulin Insulin that remains in a user’s body from a previous bolus. 0.5 or 1 unit 50 – 90 mg/dL N/A 1 Basic setup 2 3 Basic setup 1 Launch the Accu-Chek Connect app and select the Advisor icon ( ). Tap the blue line to activate the keyboard. Enter the activation code from the Accu-Chek Connect Bolus Advisor Protocol sheet provided by an Accu-Chek sales representative.* Default settings for Target Range and Meal Rise appear. Adjust these settings if desired. Select Next. *Activation code varies by country 7 1 Basic setup 5 6 Basic setup 4 Enter values for Carb Ratio, Insulin Sensitivity and Max Bolus. (Max Bolus has default of 25, which can be adjusted.) Review the settings and select the confirmation check box. Select Finish. 8 Setup is complete. Select Close to return to the Advisor. Select Back to exit the Advisor and return to the home screen. 1 Using Bolus Advisor with a current blood glucose reading 2 3 Basic setup 1 To get bolus advice, start by performing a blood glucose test with the Accu-Chek Aviva Connect meter. Select the Advisor icon in the Accu-Chek Connect app. Press OK to add a comment, then press or to highlight the desired comment and OK to select it. Press OK to send. Note: You have 10 minutes to get bolus advice for this blood glucose value. A countdown timer (upper right) helps you monitor this deadline. It will turn red after time remaining is less than 1 minute, at which time the countdown units also change from minutes to seconds. Note: If the meter and smartphone are not already paired, perform the steps required for pairing the devices, as listed in the Quick Connect Guide. Select the Carbs field to enter the estimated amount of carbs in the meal. If desired, select Add meal photo to include a photo of the meal with this record. You can take a photo of your meal using the smartphone camera. 9 1 Basic setup Using Bolus Advisor with a current blood glucose reading 4 5 3 units are recommended to help return you to the center of your target range (e.g., 90 mg/dL if the target range is 70 – 110 mg/dL). Basic setup 3 units are recommended to compensate for the 60 g of carbs to be consumed. To administer an amount different from the recommendation, tap in the bottom field and enter the actual amount. Bolus recommendation is displayed. Select Save to confirm amount of insulin taken. Note: If desired, you can also add and save additional details about this record. 10 Home screen appears with a summary of the bolus advice details. From the Home screen, you can select an entry to see all the details of a specific bolus recommendation. 1 Alternative scenarios Recording bolus insulin delivered without using bolus advice #2 Bolus advice without entering blood glucose value Basic setup #1 Use the Add button on the Home screen to enter a record for additional insulin. If desired, you can receive bolus advice without entering a current blood glucose value. Important note: Because the Accu-Check Bolus Advisor factors active insulin* into all calculations, users should enter ALL boluses into the Accu-Chek Connect app whether or not they use the Accu-Chek Bolus Advisor. Note: A reliable recommendation is best obtained with your current blood glucose value. *Active insulin describes insulin that remains in a user’s body from a previous bolus. The recommended bolus amount will reflect only the insulin required for the carbs you will consume. 11 1 Basic setup Alternative scenarios Bolus advice with a hypo blood glucose #4 Bolus advice with low blood glucose Basic setup #3 If your blood glucose is below the hypo limit (the default setting of 70 mg/dL can be modified under blood glucose settings), no bolus advice will be provided. Instead, you will receive a recommended amount of carbs to eat in order to raise your blood sugar into your target range. Record the amount of carbs you will actually consume. 12 If your pre-meal blood glucose is low but is not below your hypo limit, the Accu-Chek Bolus Advisor may calculate a negative (correction) bolus amount that will reduce the total recommended bolus for the carbs you are about to consume. 2 Additional Bolus Advisor settings To begin, launch the Accu-Chek Connect app as you did in Section 1. 1 2 Select (upper right) or (menu button—usually lower left) to access Settings. From Settings, select Bolus Insulin Advisor. 3 From the Advisor Settings menu, select Insulin Details. 4 Additional Bolus Advisor settings Then follow these steps to program additional settings—or to adjust current settings—for bolus advice based on multiple factors, including customized time block settings, current blood glucose, carbs, exercise and health events such as stress or illness. Select the dropdown menu tab to enter settings for the specific type of Bolus Insulin used. 13 2 Additional Bolus Advisor settings Additional Bolus Advisor settings 5 6 Select the appropriate description of the bolus insulin you use. If desired, select the Max Bolus field to adjust the amount. Note: Whenever you change insulin, be sure to adjust all other insulin-related settings (e.g., Offset Time, Acting Time) as necessary. Follow the same procedure to change the default settings for the Offset Time, Acting Time and Insulin Increment, which should reflect the increment of the insulin pen/ syringe used. Select Save. 14 7 To adjust current bolus advice settings, select Time Blocks, Target Ranges, Carb Ratios, and Insulin Sensitivities. Note: This screen shows when settings were last entered/changed. 2 9 10 You can program up to 8 time blocks to cover a 24-hour period. The new time block will default to the current settings for the existing time block. You can customize Target Range, Carb Ratio and/or Insulin Sensitivity settings for each time block. Time Blocks allow for different settings at different times of day. To create a new time block, select + (upper right) and enter new settings for that time period. Enter start time for the new time block. Each time block ends when the next one begins. Select Set. If only one time block is set, it will cover a 24-hour period. Important note: Instruct patients to always consult with you about actions they should take (if any) when using multiple time blocks and traveling to a different time zone. The Accu-Chek Connect app will not automatically reset the patient’s time blocks to match a new time zone. See p. 23 for details. Additional Bolus Advisor settings 8 15 2 Additional Bolus Advisor settings Additional Bolus Advisor settings 11 16 From the Advisor Settings menu, select Meal Rise and Snack Size. 12 If desired, adjust the Meal Rise. You can also add a setting for Snack Size. Select Save. 13 From the Advisor Settings menu, select Exercises. 2 You can adjust the % by which different types of exercise may affect the amount of insulin needed. Select the field to change the setting. If desired, select + Add Exercise to add a different type of exercise. You can include up to 10 exercise settings. 15 To add an exercise, select the Name field to enter a name (e.g., Tennis). Then enter the % Increase or Decrease for this exercise. The default setting is a decrease. Select Set. 16 From the Advisor Settings menu, select Health Events. Additional Bolus Advisor settings 14 When you are finished with settings for Exercise, select Save. 17 2 Additional Bolus Advisor settings Additional Bolus Advisor settings 17 18 You can adjust the % by which different health events may affect the amount of insulin needed. Select the field to change the setting. If desired, select + Add Health Event to add a different type of event. You can include up to 10 health event settings. 18 19 To add a health event, select the Name field to enter a name. Then enter the % Increase or Decrease for this event. The default setting is an increase. Select Set. When you are finished with settings for Health Events, select Save. Select Back to return to the home screen. 2 Using Bolus Advisor with a current blood glucose reading 2 To get bolus advice, start by performing a blood glucose test with the Accu-Chek Aviva Connect meter. Select the Advisor icon in the Accu-Chek Connect app. Press OK to add a comment, then press or to highlight the desired comment and OK to select it. Press OK to send. 3 Select the Carbs field to enter the estimated amount of carbs in the meal. If desired, select Add meal photo to include a photo of the meal with this record. Additional Bolus Advisor settings 1 19 2 Additional Bolus Advisor settings Additional Bolus Advisor settings Using Bolus Advisor with a current blood glucose reading 20 4 5 If desired, you could select an activity from the Exercise field. For now, select None. Select Health Events. 6 Select one or more Health Events. Select Done. 2 7 8 Optional Select Next. Additional Bolus Advisor settings Upon receiving a recommendation, you have the option to Save and log additional details. Bolus recommendation is displayed. To administer an amount different from the recommendation, select the bottom field and enter the actual amount. Select Save to confirm amount of insulin taken. After you are finished entering additional details, select Save. You cannot edit any key details that were previously entered (e.g., bolus or carb amounts). 21 2 Additional Bolus Advisor settings Additional Bolus Advisor settings 9 22 Home screen appears with a summary of the bolus advice details. From the Home screen, you can select an entry to see all the details of a specific bolus recommendation. 10 Select Close to return to the Home screen. 2 Alternative scenarios #2 Combined adjustments to bolus advice If your bolus calculation includes more than one exercise/health event, you must set the adjustment % for the combined events. Appropriate adjustments can vary from person to person, so you should discuss this with your doctor, who can help you determine the correct % to use. Choose Increase by or Decrease by and swipe the spinner to select the % setting. Select Set. Traveling to a new time zone Multiple time block designations—and their assigned settings for Target Range, Carb Ratio and Insulin Sensitivity—do not automatically change when the user enters a new time zone. For this reason, users should always consult their healthcare provider about actions to take (if any) when using multiple time blocks and traveling to a different time zone. In the example to the left, the Insulin Sensitivity setting for the last time block differs from the previous time block. Only the user’s healthcare provider can determine if this difference is clinically important so as to require the user to adjust time block settings while traveling. Additional Bolus Advisor settings #1 23 3 Appendix Advice Options – Meal Rise, Acting Time, Offset Time and Snack Size Advice Options help to make sure that Bolus Advice does not recommend a second bolus for a blood sugar event, such as a meal or a high bG level, that has already been covered by a previous bolus. After a meal, bG levels usually increase by a noticeable amount, even in people without diabetes. Depending on the type of meal, your bG can reach a maximum about an hour after your meal and return to its original level after another one to two hours. This is a normal process, so Bolus Advice takes this into account using Meal Rise. Acting Time bG level hyper Offset Time Meal Rise Appendix Meal Rise Target Value Target Range hypo Current bG value 24 Meal Time Bolus Bolus not required Currently allowed bG value: Meal Rise The dotted line shows how your bG level typically changes after a meal bolus. Bolus Advice tolerates an increased bG level within the Meal Rise range (green) without calculating an extra correction bolus. Each time you tell Bolus Advice that you have consumed more carbohydrates than the Snack Size, the Meal Rise entry is added to the bG target value. How long the Meal Rise lasts (the width of the green area) is determined by the Offset Time and the Acting Time. The currently allowed bG value considers the following factors: • The upper limit of the Target Range for your current Time Block • bG values that were tolerated as a Meal Rise and which have had a meal bolus that is still active (Acting Time) • The expected reduction of your bG level due to the effect of insulin during the Acting Time (the decrease between the end of Offset Time and end of Acting Time) • Excursions beyond the Target Value that have had a correction bolus that is still active (Acting Time) Appendix 3 25 3 Appendix Acting Time Acting Time bG level hyper The Acting Time is the time for which the insulin delivered as a bolus is still effective. It is the whole time for which an increase in bG after a meal bolus or a correction bolus is taken into account. Bolus Advice will not recommend a correction bolus for this time if your current bG level is less than the bG level covered by the previous bolus (Meal Rise or a corrected high bG). Offset Time Corrected bG Appendix Target Value Target Range hypo Current bG values 26 Time Bolus Bolus not required Currently allowed bG value: Corrected bG 3 You can program the Acting Time from 1½ to 8 hours. The Offset Time is the time taken for the bolus to take effect. After the Offset Time, your bG level should decrease because of the insulin, and at the end of the Acting Time it should return to the target level. The Offset Time must be at least 45 minutes, and the maximum value will be limited by the Acting Time that you choose. Snack Size The Snack Size defines a certain amount of carbohydrates for which a meal bolus is calculated, but no Meal Rise is triggered. No bG level above the Target Range or currently allowed bG is tolerated for this amount of carbohydrates, so Bolus Advice will calculate a correction bolus for any increase in bG after a snack. Correction bolus only Bolus Advice always compares your bG result with the currently allowed bG value, and not just with the target value for the current Time Block. The diagram to the left shows an example: The first correction bolus at 12 o’clock remains active during the Acting Time (the width of the blue area). If a measured value at 2 o’clock falls within the currently allowed bG value (height of the blue area), no new correction bolus is calculated. Appendix To choose the correct value for the Acting Time, you and your healthcare professional should think about the following: • Whether you use rapid-acting insulin analogue or fast-acting regular human insulin (the Acting Time should be longer for regular insulin) • Your average bolus amount (the larger your average bolus amount, the longer the Acting Time should be) Offset Time 27 www.accu-chek.com Roche Diagnostics GmbH Sandhofer Straβe 116 D - 68305 Mannheim ACCU-CHEK, ACCU-CHEK AVIVA CONNECT and ACCU-CHEK CONNECT are trademarks of Roche. All other product names and trademarks are property of their respective owners. © 2014 Roche Diagnostics.