User manual | the Accu-Chek Bolus Advisor Instruction Guide

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
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