Personal Continuous Glucose Monitoring Protocol · 2019-06-24 · 4 Fundamental Concepts...

Personal Continuous Glucose Monitoring ProtocolA Guide to Continuous Glucose Monitoring Integrated with Insulin Pump Therapy

Includes Alert and Trend Management as well as Threshold Suspend

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1Table of Contents

Table of Contents

Overview and Definitions 3

Fundamental Concepts 4

Candidate Selection 5

CGM Initial Alert Settings and Adjustments 6

Low Alarm and Alert Settings 7

High Alert Settings 8

Threshold Suspend Feature 9

What to Expect with Threshold Suspend 10

Identifying Threshold Suspend on the CareLink® Daily Detail Report 11

Graphs and Displays 12

Using On-Screen Data to Make Therapy Adjustments 13

Using CareLink Pro Software to Make Therapy Adjustments 14

CGM Initiation Settings Form 21

References and Suggested Reading 22

2 Authors

Bruce W Bode, MD, FACEAn internationally known speaker and author on insulin pump therapy and continuous glucose monitoring, Dr Bode, a graduate of Emory University School of Medicine, is in private practice with Atlanta Diabetes Associates and is an Associate Professor of Medicine at Emory University He is active in both Georgia Diabetes Camps and the Juvenile Diabetes Research Foundation Dr Bode is also the editor of the American Diabetes Association’s Medical Management of Type 1 Diabetes

Francine R Kaufman, MDFrancine Ratner Kaufman, MD is Chief Medical Officer and VP of Global Clinical, Medical and Health affairs at Medtronic Diabetes and a Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications of the University of Southern California Dr Kaufman was president of the American Diabetes Association (2002-03), and serves on the Advisory Council of the Diabetes Branch of the National Institutes of Health

While every reasonable precaution has been taken in the preparation of this guide, the authors, sponsor and publisher assume no responsibility for errors or omissions, nor for the uses made of the materials contained herein and the decisions based on such use This document does not contain all of the information necessary for the proper care and treatment of patients with diabetes As such, no individual may rely on the information presented herein in forming a comprehensive treatment program or in treating any patient with diabetes No warranties are made, expressed or implied, with regard to the contents of this work or to its applicability to specific patients or circumstances Neither the author, sponsor, nor the publisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide

3Overview

OverviewThis guide is for healthcare providers and discusses the personal continuous glucose monitoring (CGM) initiation and adjustment process for patients who are also using insulin pump therapy In the STAR3 protocol, patients were started on pump therapy and then began CGM therapy within 7–14 days using a combination of face-to-face clinic visits, follow-up telephone calls and self-study on-line modules While timelines and visit schedules may be individualized, the sequential clinical strategy of initiation and fine-tuning glycemic control with Personal CGM is explained

Definitions1

Professional CGM devices are owned by the healthcare provider, clinic, or hospital Patients typically wear the device for several days, keeping a record of food and activity, and then return it to the office for download and interpretation During use, the data can be blinded to the patient, allowing for unbiased assessment of glucose control Professional CGM in the masked version does not have alerts to indicate hypoglycemia or hyperglycemia, and is recommended for use on an episodic basis Professional CGM can also be used in real-time on an episodic basis described below

Personal CGM, sometimes referred to as real-time CGM, is owned by the patient It provides glucose readings up to every five minutes and glucose alerts CGM systems can be downloaded by the patient and the physician for interpretation Personal CGM may be a stand-alone device, with the sole function of monitoring glucose, or a device that is integrated into an insulin pump system

* Threshold Suspend is available in the MiniMed® 530G with Enlite® See the MiniMed 530G System User Guide for complete information and instructions for use

4 Fundamental Concepts

Fundamental ConceptsDuring the past decade, continuous glucose monitoring (CGM) has evolved from being used as a research tool, to being used daily in clinical practice 1 Today, Personal CGM is successfully used by patients with type 1 diabetes, including children, adolescents, and adults, as well as by patients with type 2 diabetes

Note: MiniMed® 530G with Enlite® is labeled for use in ages 16 years and older The Paradigm® REAL-Time Revel™ System, used with Sof-sensor® glucose sensor, is indicated for ages 7 years and older A version of the product specially designed for children is indicated for patients ages 7 to 17

The following fundamental principles guide current CGM practice:

1. CGM devices measure interstitial glucose, which is related to, but not the same as capillary glucose

• CGM values will usually lag behind self-monitoring of blood glucose (SMBG) due to physiologic delay of glucose transfer between interstitial and blood compartments

• Depending on the rate of change, CGM values are generally within 15%–20% of SMBG values, with greater differences during rapid rates of change * Patient understanding that blood glucose (BG) does not equal sensor glucose (SG) helps to set realistic expectations and the importance of trends versus discrete values

2. CGM systems consist of four components:

• The glucose sensor is inserted into the subcutaneous tissue, where glucose oxidase measures the interstitial glucose

• The transmitter is connected to the glucose sensor, and communicates to the receiver or insulin pump

• The receiver or insulin pump displays the glucose values and trends It also has various alert features and download capabilities Features of the MiniMed 530G system include:

− Updated sensor glucose values every 5 minutes

− Rate of change arrows

− 3, 6, 12, and 24-hour trend graphs

− Alert settings for Low and High Glucose Limits, Predictive High and Low, and Rate of Change

− Threshold Suspend (see pages 9 and 10)

• CareLink® Personal and Pro software

3. CGM devices are indicated for use as adjunctive to SMBG2

• All treatment changes are to be based on traditional SMBG tests, not the SG values

• The CGM system is calibrated using SMBG with a glucose meter, usually 3–4 times a day for optimal results

4. The more frequently patients use CGM, the greater improvement in glucose control3,4

• Encourage patients to adopt full-time use of CGM However, patients who use CGM intermittently also benefit

• Minimizing excessive alerts upon initiation increases acceptance of the therapy

• For those patients who use CGM intermittently, focus on times when glucose management is particularly difficult

− Travel

− Illness

− Stress

− Unusual physical activity

− When glucose targets are not met

* The MARD is 13 6% when calibrating 3–4 times a day, and 14 7% when calibrating once every 12 hours during actual use with the MiniMed 530G with the Enlite sensor 5

5Candidate Selection

Candidate SelectionIndications Patients with type 1 diabetes and patients with type 2 managed on insulin with the following characteristics:

• A1C above target

• Excessive glycemic variability

• Frequent hypoglycemia or hypoglycemia unawareness

• Nocturnal hypoglycemia

• Post-prandial hyperglycemia

• Pregnancy/Pre-pregnancy*

• Trouble with glucose control during exercise or periods of stress

Patient Requirements • Willingness to be attached to a sensor and transmitter

• Willingness to perform SMBG to calibrate system and to validate SG values prior to making treatment decisions

• Willingness to work with healthcare team to analyze data and make appropriate treatment adjustments

Precautionary Areas • Skin and site irritation and infection

• Reduces available sites for insulin infusion

*Enlite is not approved for pregnant women

6 CGM Initial Alert Settings and Adjustments

CGM Initial Alert Settings and AdjustmentsLimit Alerts at InitiationIt is recommended that patients start with a limited number of alert settings at CGM initiation This strategy eases patients into their CGM experience by minimizing alerts while they are beginning to learn about their glucose trends and patterns It balances the benefits of seeing the rate and direction of glucose change, while avoiding information overload and the frustration of excessive alarms As patients gain an understanding of how food, insulin, and exercise affects their glucose levels, glucose control should begin to improve Once this occurs, additional alerts may be turned on and limits may be tightened to take full advantage of CGM capabilities

Adding and Adjusting Alerts Using CareLink® Pro Software ReportsAfter the patient has become familiar with basic functions of the CGM system and demonstrates the ability to interpret the graphs, additional alert settings can be added It is important to balance the ability of the patient to tolerate additional alerts with the value of the information obtained from the alerts In general, most patients want to be alerted only when it is necessary to take action While it may seem logical for every patient to be alerted of values over 250 mg/dL, patients who have many postprandial glucoses over 250 mg/dL will find the frequency of alerts unacceptable It is difficult to anticipate how an individual patient will respond to frequent alerts until they are actually utilizing the system 6 Timely follow-up for alert setting evaluation and adjustment is important for success

Use CareLink software to begin adjusting the settings within the first few days, and no later than 7–14 days after CGM initiation The CareLink Therapy Management Dashboard example below demonstrates how to use CareLink reports to individualize settings For this patient, setting the Threshold Suspend at 60 mg/dL, and the Low Glucose Limit at 70 mg/dL at initialization, and later setting the High Glucose Limit at 300 mg/dL may allow the patient to use CGM without receiving excessive alarms See pages 7 and 8 for recommended initial CGM settings and adjustment considerations

Therapy Management Dashboard Sensor Overlay

7

Threshold Suspend Alarm (MiniMed® 530G System only)

• Alarms with a siren and suspends all insulin delivery when the sensor glucose reaches or falls below the programmed Threshold Suspend setting

• Alarm will continue to siren until patient responds

• Patient may resume insulin delivery at any time

• Can be set from 60-90 mg/dL

60 mg/dL • Set higher for hypoglycemia unaware

• Make sure there is at least 10 mg/dL difference between Low Glucose Limit and Threshold Suspend Limit

• For those patients who need more time to treat before Threshold Suspend is activated, consider raising the Low Glucose Limit

Low Glucose Limit Alert

• Alerts when sensor glucose reaches or has fallen below the sensor glucose limit

• Can be set from 40–390 mg/dL

• May set up to 8 different time segments per day

70 mg/dL • Set higher (90 or 100 mg/dL) for hypoglycemia unaware

• If patient reports too many alerts, consider setting the limit lower, coupled with therapy adjustments

• If patient experiences hypoglycemia without alerting, set limit higher

Low Predictive Alert

• Alerts when low glucose is predicted to occur

• Used to prevent or reduce the severity of the low glucose excursion

• Can be set at OFF, or from 5–30 minutes

OFF • Consider using with experienced CGM patients who want more warning before a low occurs

• Set at 30 minutes

Fall Rate of Change Alert

• Alerts when sensor glucose has fallen at specified rate of change

• Fall rate is most important when sensor glucose is near the low limit

• Can be set from 1 1–5 0 mg/dL/minute

OFF • Set only if extreme rate of change is valuable, as this setting will increase the frequency of alerts

• Set at 4 0 mg/dL/minute

• If patient reports too many alerts, consider turning this alert OFF

Low Repeat

• Used to select the length of time before the Low Alerts and Threshold Suspend alarm repeat after they are cleared, if the condition still exists

• Is set if one or more of the Low Alert settings or Threshold Suspend is turned on

• Allows time for patient to treat hypoglycemia and for glucose to rise

• Applies to all Low Alerts and Threshold Suspend

• Can be set from 5 minutes–one hour

20 minutes • Default is set at 20 minutes

Low Alarm and Alert SettingsLow Alerts are intended to provide warning of actual or impending hypoglycemia so the patient can respond to prevent or reduce the low excursion Initial settings are intended to balance safety while minimizing nuisance alerts Settings are individualized in all cases

Low Alarm and Alert Settings

Alarm and Alerts Initial Settings Considerations and Adjustments

8

High Glucose Limit Alert

• Alerts when the sensor glucose has reached or risen above the sensor glucose limit

• Can be set from 50–400 mg/dL

• May set up to 8 different time segments per day

OFF • Set at 250 mg/dL

• Alternatively may use CareLink data to determine initial setting

• If patient reports too many alerts, consider increasing the setting, coupled with therapy adjustment

• As glucose control improves and hyperglycemia decreases, consider decreasing the setting

High Predictive Alert

• Alerts when high glucose is predicted to occur

• Used to prevent or reduce the severity of the high glucose excursion

• Can be set from 5–30 minutes

OFF • Set at 15 minutes

• Consider leaving OFF, to decrease the burden of frequent alerts with limited perceived value

Rise Rate of Change Alert

• Alerts when sensor glucose has risen at a specified rate of change

• May be used as indicator for missed boluses

• Set only if extreme rate of change is valuable

• Can be set from 1 1–5 0 mg/dL/minute

OFF • If used, consider setting at 4 0 mg/dL/minute to alert patients only of very rapid changes in glucose levels that may occur when patient misses a bolus

• If patient reports too many alerts consider turning this alert OFF

• When patient’s missed bolus behavior improves, consider turning feature OFF to prevent excessive alerts

High Repeat

• Used to select the length of time before the High Alerts repeat after they are cleared, when the condition still exists

• Can be set if one or more of the High Alert Settings is turned on

• Allows time for insulin to take effect and high glucose to decrease

• Applies to all High Alerts

• Can be set from 5 minutes–3 hours

N/A

or

Two hours

• Default is set at one hour, so will need to increase setting at initiation to minimize alerts

High Alert SettingsHigh alerts are intended to detect actual or potential hyperglycemia so the patient can respond and prevent or reduce the high excursion Initial settings are intended to balance safety while minimizing nuisance alerts Settings are individualized in all cases

High Alert Settings

* Bode, BW, Kaufman, FR Personal Continuous Glucose Monitoring Protocol: A Guide to Continuous Glucose Monitoring Integrated with Insulin Pump Therapy Northridge, CA: Medtronic, Inc Diabetes; 2012

Alerts Initial Settings Considerations and Adjustments

9Threshold Suspend Feature

Insulin infusion Insulin infusion stopped resumed Max. duration = 2 h

12 AM 3 AM

Time

180 10.0

8.9

7.8

6.7

5.6

4.4

3.3

2.2

160

140

120

100

80

60

40

Glu

cose

(mg/

dL) G

lucose (mm

ol/L)

6 AM

Threshold Suspend FeatureThreshold Suspend sirens and shuts off insulin delivery when the sensor glucose value reaches or drops below the programmed Threshold Suspend setting Patient should take a fingerstick and take measures to prevent or treat hypoglycemia The patient can resume delivery any time All insulin delivery will be suspended for two hours if the patient is unable to respond to the Threshold Suspend alarm After two hours, the basal rate automatically resumes for four hours After four hours, if the sensor glucose remains below the Threshold Suspend setting, the basal rate suspends again This cycle continues for a maximum of twelve hours (two cycles), until the calibrations run out, until the pump battery dies, etc The patient may respond at any time, clear the alarm, and resume insulin delivery

If the patient responds, clears the alarm and chooses to continue the Suspend, the pump will stay suspended until the two hour cycle has completed Once basal insulin delivery resumes, if the patient’s SG remains or falls below the programmed Threshold Suspend setting and his Low Repeat time has passed, then his pump will again suspend insulin delivery for two hours

Threshold Suspend Key Points: • Makes a siren sound and suspends all insulin delivery when the sensor glucose reaches or falls below the programmed

Threshold Suspend setting

• Sirens until the patient clears the alarm

• Patient can resume delivery at any time

• Can be set from 60 – 90 mg/dLThe Threshold Suspend Concept

Note: The Threshold Suspend feature is available in the MiniMed® 530G system only See the MiniMed 530G System User Guide for complete information and instructions for use

WARNING: The Threshold Suspend feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold Under some conditions of use the pump can suspend again resulting in very limited insulin delivery over a four hour period Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the MiniMed 530G` System User Guide

10

What to Expect with Threshold Suspend

Frequency of Threshold SuspendA Threshold Suspend event may occur every day or every other day, as some patients commonly experience glucose excursions of 60–90 mg/dL The initial setting for Threshold Suspend should be at 60–70 mg/dL, with higher settings (80–90 mg/dL) suggested in those with a history of severe hypoglycemia, renal insufficiency, or other conditions in which avoidance of lower glucose levels is desired

Duration of Threshold SuspendThe Threshold Suspend feature is designed to stop insulin delivery at a user-set threshold when the patient does not respond to a low alarm, such as during sleep CareLink data from patients using the MiniMed Paradigm® Veo™ system* indicate suspend events that last the full two-hours with no patient response account for 10–15% of all threshold suspends, with the majority of these occurring at night The data from these patients show glucose levels rising on average 10–20 mg/dL per hour for 4 hours after the suspend begins, including after the automatic resumption of basal insulin delivery at the two-hour mark 7

Threshold Suspend and Routine Treatment of Hypoglycemia Threshold Suspend should be viewed as a feature for unresponsive patients when there is no one available to help them When the patient is awake and alert, patients should respond to a Threshold Suspend event by cancelling the Suspend alarm, checking their BG by fingerstick and treating their hypoglycemia with oral glucose as directed They can resume basal insulin delivery upon treatment of the hypoglycemia Data from CareLink show that during the daytime when Threshold Suspend occurs it is most frequently right before lunch or during exercise 7

Reinforce with families and caregivers that a patient with hypoglycemia who is unresponsive should be treated with glucagon

Recognizing Threshold Suspend Events in CareLink Pro SoftwareThreshold Suspend events can be easily identified in CareLink reports A Threshold Suspend that lasts two hours and shows no patient response is bounded by an alarm symbol on both ends of the two-hour time period with the basal insulin rate going to zero A Threshold Suspend event that has an alarm symbol only at the start indicates the patient responded and cleared the alarm

What to Expect with Threshold Suspend

*The MiniMed Paradigm Veo insulin pump is not approved for use in the US and uses a slightly different threshold suspend algorithm from the MiniMed 530G insulin pump

11Identifying Threshold Suspend on the Daily Detail Report

Identifying Threshold Suspend on the CareLink Daily Detail ReportThe Daily Detail reports below each show a Threshold Suspend event Threshold Suspend events are indicated by the basal rate drop to 0 0 units/hour as well as a color change from green to red, in the line depicting the basal rate A patient-initiated suspend is depicted by a basal rate drop to 0 0 units/hour in green

Patient unresponsive. Basal suspended for two hours, then

automatically resumed.

Patient cleared Threshold Suspend alarm and kept the basal rate suspended. After approximately one

hour, the patient resumed basal delivery.

Patient cleared the alarm, tested BG, and resumed insulin delivery immediately.

12 Graphs and Displays

Graphs and DisplaysThere are 3, 6, 12, and 24-hour graphs available for display on the MiniMed 530G system The graphs show High and Low Glucose Limit lines, the sensor glucose (SG) tracing, and the most recent SG value (or the reason why there is no value shown), as well as the time the SG value was updated Historical data up to 24 hours can be viewed by scrolling back through the graphs

If the SG rises or falls faster than a certain rate, trend arrows automatically appear in the graphs next to the SG measurement

SG has been falling at a rate of 1 0 to 2 0 mg/dL per minute

SG has been falling at a rate of 2 0 mg/dL or more per minute

SG has been rising at a rate of 1 0 to 2 0 mg/dL per minute

SG has been rising at a rate of 2 0 mg/dL or more per minute

Trend Arrows

Below is an example of a 24-hour graph Please see the MiniMed 530G System User Guide for further information about graphs and pump displays

Sensor glucose tracing

High alert limit

Low alert limit

Time of day

Shaded area is the 12 hours from 6 pm to 6 am

Time of sensor glucose value update

Sensor glucose value

Trend arrow

13Using On-Screen Data to Make Therapy Adjustments

Using On-Screen Data to Make Therapy AdjustmentsThe protocol for the Juvenile Diabetes Research Foundation (JDRF) CGM study provided recommendations for insulin dose adjustments based on trend arrows 8 The guidelines below are adapted from these recommendations

Trend ArrowsAfter a patient has become comfortable responding to alarms and alerts and interpreting glucose trends, you may want to consider adding trend arrows to the insulin dose adjustments Patients should use the Bolus Wizard® calculator using fingerstick BG values to determine the bolus insulin recommendation, and then can be instructed to consider making dose adjustments to the Bolus Wizard estimate based on the on-screen trend arrows

If fingerstick BG is low before bed, or anytime a low alert occurs

• Correct the low with glucose tablets

• Check to see if there are trend arrows on the pump screen

• Consider taking more glucose if down arrows are present

− For example, if 15 grams is normally used to treat a low, consider adding 5 grams glucose for one arrow and 10 grams for 2 arrows

If fingerstick BG is low before food intake

• Do not bolus while glucose is low

• Treat the hypoglycemia

• After treating the hypoglycemia and the glucose is within target, calculate the bolus to cover the meal, check for trend arrows on the pump, and adjust based on the arrows using the guidelines below

If fingerstick BG is at or above target before a meal or whenever a high alert occurs

• Check to see if there are trend arrows on the pump screen

• Calculate your meal bolus and/or correction dose and adjust based on the trend arrows using the guidelines below

Adjustments can also be made for trend arrows when the BG is within target range This should be initiated after the patient has experience with adjusting doses for high and low BGs using trend arrows When BG is within target range, use the arrows to give minor correction doses and small amounts of glucose as appropriate

As always, individual patient history should be considered with all recommended dosage adjustments

No arrows

Decrease dose by 10%

Decrease dose by 20%

No change in dose

Increase dose by 10%

Increase dose by 20%

Bolus Adjustment Guidelines Using Trend Arrows

14

Using CareLink Pro Software to Make Therapy Adjustments

The data provided by CareLink should be reviewed in a systematic format Start by looking at the Therapy Management Dashboard for a sense of overall control or areas of concern

First, look at the overnight period and make any necessary changes Next, evaluate the pre-meal time periods and adjust basal rates as needed Then evaluate the post-meal time periods and adjust carbohydrate ratios or timing of insulin delivery as needed Identify any behavioral issues that might be impacting the patient’s management and counsel or educate as needed Generally, 1 to 2 therapy changes and 1 to 2 behavioral changes at a time with a follow-up evaluation is appropriate

1 Sensor Overlay*Evaluate for a sense of overall control or areas of concern

2 Insulin Profile GraphEvaluate insulin profiles How many basal rates? Are they appropriate? Is variance appropriate? Evaluate average active bolus insulin Note active insulin in overnight time period before adjusting overnight basal rate

3 Sensitivity and Carb RatioEvaluate insulin sensitivity and carb ratios Are they appropriate? Consider checking carb ratio against 450 rule (450 divided by TDD) and insulin sensitivity against 1700 or 2000 rule (1700 or 2000 divided by TDD)

4 Bedtime to Wake-up Sensor Overlay*Evaluate sensor glucose from bedtime to wake-up Is patient within target during this time period?

5 Meal Sensor Overlay*Evaluate glucose values around meal times when patient uses the Bolus Wizard Is pre-meal value within target? Is post-meal rise within 30–60 mg/dL?

6 Action PlanUse this section to record notes for patient records, to provide comments and recommendations for patient therapy, and/or to record documentation for health insurance providers

Therapy Management Software

12/4/2011 - 12/17/2011Therapy Management Dashboard

Avg Food Bolus: 4.1 ± 2.2U Avg Carbs: 28 ± 14g Post-meal SG Avg: 136 ± 29mg/dL Pre-meal SG Avg: 137 ± 42mg/dL Dinner: 4:00 PM - 10:00 PM (19)

Avg Food Bolus: 6.7 ± 2.2U Avg Carbs: 40 ± 13g Post-meal SG Avg: 130 ± 31mg/dL Pre-meal SG Avg: 119 ± 53mg/dL Lunch: 11:00 AM - 3:00 PM (16)

Avg Food Bolus: 8.9 ± 1.9U Avg Carbs: 44 ± 9g Post-meal SG Avg: 135 ± 30mg/dL Pre-meal SG Avg: 109 ± 34mg/dL Breakfast: 6:00 AM - 10:00 AM (14)

Wake-up: 5:00 AM - 9:00 AMBedtime: 8:00 PM - 12:00 AM

Bedtime to Wake-up

5.1 per dayHigh SG Alarms

20.5 per dayLow SG Alarms

6d 20h per weekWear Duration

127 ± 45 mg/dLAvg SG

Sensor Use

Every 4.7 / 3.5 daysRes./Site Change1h 14m per day Time2.3 per dayThreshold Events1h 22m per daySuspend Duration

-1.4U (0.3 boluses) Override (-)0.2U (0.1 boluses) Override (+)4.3U (3.9 boluses) Correction23.8U (3.9 boluses) Food25.7U (4.6 boluses) Bolus Wizard0.0U (0.0 boluses) Manual Boluses42 / 58Basal/Bolus Ratio44.0 ± 4.2UInsulin TDDPer DayPump Use

5:00 PM-6:15 PM

8:40 AM-10:35 AMTime Period

11:00 PM-1:35 AM

Hyperglycemic Patterns (3)

8:39 PM-10:22 PM (2)

12:47 PM-4:39 PM (7)Time Period

1:34 AM-7:44 AM (9)

Hypoglycemic Patterns (6)**

140 ± 26g per dayCarbs Entered

6.4 per dayBG Readings

138 ± 53mg/dLAvg BG

Statistics

Bol

us In

sulin

(U, a

ctiv

e 4

hr)

Basal Rate Bolus Insulin

** Only highest priority shown.

24-Hour Analysis – Sensor, Insulin, & Settings

Action Plan

Reviewed By

Date Time

5

1

2

3

4

6

15

7 Statistics TableEvaluate average BG and standard deviation (SD) Mean glucose values between 150–160 mg/dL are generally acceptable to meet A1C target An SD of less than half the mean glucose is generally acceptable Are there an appropriate number of BG readings/day? Are the carbs per day appropriate?

8 Hypo- and Hyperglycemic Patterns Tables*Evaluate hypo-and hyperglycemic patterns Are there areas of concern? Are there extreme excursions of hypo- or hyperglycemia?

9 Pump Use TableEvaluate total daily dose of insulin Is it appropriate based on weight and age? Evaluate basal to bolus ratio Is it appropriate for age and type of diabetes? Bolus is generally ≥ 50% Evaluate pump features being used, e g Bolus Wizard, amount of correction, number and type of overrides Are reservoir and site changes occurring appropriately?

10 Suspend Duration***Evaluate suspend duration Are there lengthy periods of suspends? Are there frequent Threshold Suspend events?

11 Sensor Use TableEvaluate average SG and SD Evaluate amount of sensor wear Evaluate number of alarms per day

Therapy Management Dashboard

Example of Therapy Management Dashboard†

Use this report to review the big picture as well as specific behaviors

* Targets determined by provider during report setup †To obtain the Therapy Management Dashboard, a minimum of five days (1440 data points) of pump and sensor data are required in the reporting period *** Threshold Suspend Events and Time will be displayed if device supports this feature






Bedtime to Wake-up





Sensor Use



5:00 PM-6:15 PM


11:00 PM-1:35 AM


8:39 PM-10:22 PM (2)


1:34 AM-7:44 AM (9)





Statistics

Bol

us In

sulin

(U, a

ctiv

e 4

hr)




Action Plan

Reviewed By

Date Time

7

8

9

10

11






Bedtime to Wake-up





Sensor Use



5:00 PM-6:15 PM


11:00 PM-1:35 AM


8:39 PM-10:22 PM (2)


1:34 AM-7:44 AM (9)





Statistics

Bol

us In

sulin

(U, a

ctiv

e 4

hr)




Action Plan

Reviewed By

Date Time

16 Episode Summary

Example of Episode Summary†

Use this report to evaluate events that precede hypoglycemic and hyperglycemic episodes You may also use this as a “conversation map” to develop questions you may want to discuss with the patient in order to make therapy changes or provide additional education

1 Hypoglycemic/Hyperglycemic Episode Charts (22 different algorithms)*Use this to assist in identifying and ranking events that precede hypo- and hyperglycemic episodes There can be more than one event preceding an episode and it is possible that no events precede an episode You may want to obtain more information from the patient about these events

2 Most Common Event Types Pie Charts (for top 3 preceding events)Evaluate the hypo- and hyperglycemic episodes in relation to the total number of occurrences for each event during the reporting period If < 10%, may not require evaluation

3 Event Type Descriptions TableConsider possible therapy adjustments or education related to hypo- and hyperglycemic episodes

4 Other Observations Table (6 algorithms)Identify possible behavior changes related to pump, CGM, and/or meter usage

12/4/2011 - 12/17/2011Episode Summary

21 Hypoglycemic Episodes, by preceding Event Type - Threshold: ≤70 mg/dL

Most Common Event Types preceding Hypoglycemia

Consider assessing the Bolus Wizard settings, counseling your patienton accurate carbohydrate counting, and/or the timing of insulin deliverywith respect to carbohydrate intake.

43Bolus Wizard FoodBolus

Consider assessing your patient’s insulin sensitivity factors.Considercounseling your patient on the management of hyperglycemia.

48HyperglycemiaPrecedingHypoglycemia

Consider counseling your patient to take action to avoid hypoglycemia.48Rapid FallingSensor Rate OfChange

Description%Event Types

Event Type Descriptions

Consider counseling your patient on bolus use with meals and/orcorrecting rapid glucose excursions.

31Rising Sensor Rateof Change WithoutBolus

Consider counseling your patient on the management of hypoglycemia.33Overcorrection ofHypoglycemia

Consider assessing the Bolus Wizard settings, counseling your patienton accurate carbohydrate counting, and/or the timing of insulin deliverywith respect to carbohydrate intake.

39Bolus Wizard FoodBolus

Description%Event Types

Event Type Descriptions

Most Common Event Types preceding Hyperglycemia

54 Hyperglycemic Episodes, by preceding Event Type - Threshold: ≥140 mg/dL

No overall issues observed.Other Observations

3

4

*Targets determined by provider during report setup †To obtain the Episode Summary, a minimum of five days (1440 data points) of pump and sensor data are required

2

1

17

SuspendDuration(h:mm)

TubingAmount (U)

TubingFills

CannulaAmount (U)

CannulaFillsRewindOverridden

WithCorrection

WithFood

BolusWizardEvents

ManualBoluses

SensorDuration(h:mm)

BGReadings

Fill EventsBolus EventsGlucose Measurements

Adherence (1 of 1)12/4/2011 - 12/17/2011

22223:454Sunday12/4/2011

2:0033324:005Monday12/5/2011

20:5415.610.31154522:507Tuesday

12/6/2011

2:0045524:008Wednesday12/7/2011

43:36144424:005Thursday

12/8/2011

21:20276720:509Friday

12/9/2011

1:0312.310.92134424:008Saturday12/10/2011

22324:004Sunday12/11/2011

1:2333424:005Monday12/12/2011

33523:306Tuesday12/13/2011

31:1711.610.31123321:055Wednesday

12/14/2011

43:3855724:008Thursday

12/15/2011

41:1566724:0010Friday

12/16/2011

0:48255524:005Saturday12/17/2011

19h 14m13.2U/fill30.4U/fill

437.8%84.4%85.9%4.6/day0.0/day13d 16h 00m6.4/daySummary

Partial day Note: Partial days will not be included in summary averages. Days on which a time change occurred are considered to be partial days.Low Suspends

SuspendDuration(h:mm)

TubingAmount (U)

TubingFills

CannulaAmount (U)

CannulaFillsRewindOverridden

WithCorrection

WithFood

BolusWizardEvents

ManualBoluses

SensorDuration(h:mm)

BGReadings

Fill EventsBolus EventsGlucose Measurements

Adherence (1 of 1)12/4/2011 - 12/17/2011

22223:454Sunday12/4/2011

2:0033324:005Monday12/5/2011

20:5415.610.31154522:507Tuesday

12/6/2011

2:0045524:008Wednesday12/7/2011

43:36144424:005Thursday

12/8/2011

21:20276720:509Friday

12/9/2011

1:0312.310.92134424:008Saturday12/10/2011

22324:004Sunday12/11/2011

1:2333424:005Monday12/12/2011

33523:306Tuesday12/13/2011

31:1711.610.31123321:055Wednesday

12/14/2011

43:3855724:008Thursday

12/15/2011

41:1566724:0010Friday

12/16/2011

0:48255524:005Saturday12/17/2011

19h 14m13.2U/fill30.4U/fill

437.8%84.4%85.9%4.6/day0.0/day13d 16h 00m6.4/daySummary

Partial day Note: Partial days will not be included in summary averages. Days on which a time change occurred are considered to be partial days.Low Suspends

1 Sensor Duration Evaluate the amount of time per day the sensor is worn

2 Suspend Duration Evaluate the total time the pump is suspended per day (includes Threshold Suspend and manual suspend events)

3 Threshold Suspend EventsEvaluate the number of Threshold Suspend events per day The number of total Threshold Suspend events precedes the icon No number in front of the icon signifies one event

4 Manual SuspendManual suspends do not have an icon indicator If there is no Threshold Suspend icon, all of the suspend duration is from one or more manual suspends

3

4

2

Example of Adherence Report

Use this report to analyze patient behaviors

1

Adherence Report

18

Sensor & Meter Overview (3 of 3)12/4/2011 - 12/17/2011

Basal Bolus Suspend Time changeSensor trace

Interrupted

BG reading

Temp basalOff chart Injected insulin (U)Threshold Suspend

Exercise

Other

Daily Snapshots

1 Glucose Section*Evaluate meter and sensor glucose

2 Carbs SectionEvaluate carbohydrate intake Is it appropriate for patient? Is there insulin given for all carbohydrate entries?

3 Insulin SectionEvaluate insulin delivery Are there multiple boluses? Are there frequent Threshold Suspend events? Are suspend time periods appropriate? Is the temp basal feature being used?

*Targets determined by provider during report setup

Sensor & Meter Overview (3 of 3)12/4/2011 - 12/17/2011

Basal Bolus Suspend Time changeSensor trace

Interrupted

BG reading

Temp basalOff chart Injected insulin (U)Threshold Suspend

Exercise

Other

Thursday 12/15/2011Daily Detail (12 of 14)

----4.500.4002.20----Active Insulin (U)

2.701.402.60--2.20--2.00Correction Bolus (U)

37 37 37 35 35 35 35Insulin Sensitivity Setting(mg/dL per U)

100 - 120 100 - 120 100 - 120 100 - 120 100 - 120 100 - 120 110 - 120BG Target Setting (mg/dL)

220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)

7.07.06.06.05.05.05.0Carb Ratio Setting (g/U)

17413039--41--Carbs (g)

--------------Difference (U)

5.107.205.006.50--8.202.00Recommended Bolus (U)

--------------+ Square Portion (U, h:mm)

5.107.205.006.50--8.202.00Delivered Bolus Norm (U)

NormalNormalNormalNormal--NormalNormalBolus Type

11:32 PM7:15 PM12:06 PM10:43 AM9:26 AM6:51 AM12:35 AMTime

7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)

± 4.244.050.6Total Daily Insulin (U)

5.44.9Carbs/Bolus Insulin (g/U)

± 26140168Daily Carbs (g)

13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)

2%20%--Readings Below Target

48%4362%5Readings Above Target

6.4/day898BG Readings

± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert

Injected insulin (U)Pump rewind Threshold Suspend

Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other

Example of Sensor & Meter Overview Report: Daily Snapshots

Use this report to analyze glucose levels, carbohydrate intake, and insulin delivery to assist in identifying trends

For more details of each day, see the Daily Detail Report

1

2

3

19Daily Detail Report


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other


----4.500.4002.20----Active Insulin (U)




220 174 218 122 198 108 191BG (mg/dL)

2.405.805.006.50--8.20--Food Bolus (U)


17413039--41--Carbs (g)

--------------Difference (U)






7654321Bolus Event

Bolus Events

41.0U7----Fills

58%25.767%34.0Daily Bolus (U)

42%18.333%16.6Daily Basal (U)




13d 16h 1.11d 0h 3.4Avg AUC < 70 (mg/dL)

13d 16h 13.31d 0h 21.9Avg AUC > 140 (mg/dL)

± 45 127± 59 135Sensor Avg (mg/dL)




± 53 138 167Avg BG (mg/dL)

- 12/1712/412/15Statistics

Time changeSuspend

Temp basal

Basal

Off chart

BG reading

Interrupted

Sensor trace Bolus

Alarm

Linked BG

Calibration BG

Glucose alert


Exercise

Other

Meter BG ReadingGlucose Alert Carbohydrate Gram Entries

Patient checked BG, calibrated, entered carbohydrates and bolused simultaneously

Basal Rate Change Bolus Delivery

Example of Daily Detail Report

Use this report to look at more specific details (time, amount, type) of each bolus given as well as suspend and temp basal events

2

3

1 Threshold Suspend event that was not responded to Auto resume of basal insulin after 2 hours of suspend shown

2 Threshold Suspend event that was responded to before auto resume of basal

3 Calibration BG

4 Exercise entered via Capture Events feature

5 User initiated Suspend

6 An example of multiple repeated alerts set at narrow ranges

1

4

6

5

20

Example of Device Settings Report

Use this report to evaluate insulin pump and sensor settings

1 Basal SettingsEvaluate basal settings Is the number of basal rates appropriate? Is variance between rates appropriate?

2 Bolus SettingsEvaluate bolus settings Are they appropriate? You may want to check the carb ratio against the 450 rule and the sensitivity against the 1700 rule Are the Bolus Wizard glucose targets appropriate? Is the Active Insulin time appropriate? Overall, do the settings make sense?

3 Sensor SettingsEvaluate sensor settings Are they appropriate? Are alerts set appropriately?

4 UtilitiesEvaluate alert type, Threshold Suspend value (if pump is enabled with this feature), and low reservoir warning Are they appropriate?

5 NotesUse this section to record notes for patient records, to provide comments and recommendations for patient therapy Provide a copy of this page to the patient for documentation of doses and settings

Device Settings Report

Sunday 12/18/2011 10:59 AMDevice Settings Snapshot

OnBlood Glucose Reminder

OnDual/Square (Variable)

25.0 UMaximum Bolus

--Insulin Concentration

4:00Active Insulin Time(h:mm)

g, mg/dLUnits

OnBolus Wizard

Bolus

19.425 U24-HourTotal 20.775 U24-Hour

Total --24-HourTotal

0.77520:00

0.77517:00

0.85013:00

0.75010:00

0.8758:00

0.8756:00

0.8504:00

0.7752:00

0.8000:00

U/hrTIME

7.017:00

6.010:30

5.00:00

RatioTIME

3712:00

350:00

SensitivityTIME

120 1005:00

120 1100:00

HighLowTIME

mg/dLBG Units

Transmitter ID

OnSensor

0:02Graph Timeout (h:mm)

0:30Missed Data/Weak Signal(h:mm)

180 70AUC Limit: Low | High

(mg/dL)

0:30Calibration (Alert) Repeat(h:mm)

1:00Calibration Reminder(h:mm)

OffAuto Calibration

Pattern A Pattern B

Utilities

Sensor

Blood GlucoseTarget (mg/dL)

Insulin Sensitivity(mg/dL per U)

Carbohydrate Ratio(g/U)

0.875

0.800

0.925

0.950

0.825

0.925

0.800

0:00

2:00

4:00

6:00

10:00

13:00

17:00

U/hrTIME

----

U/hrTIME

20 UAmount

Insulin UnitsLow Reservoir Warning

60Threshold Suspend (mg/dL)

Beep MediumAlert Type

0.10 UEntry (Step)

OffEasy (Audio) Bolus

Percent of BasalTemp Basal Type

2.00 U/hrMaximum Basal Rate

Basal

Standard (active)

----

End(h:mm)

Start(h:mm)

Off

MissedBolus

Reminder

OffOffRate Alert: Fall | Rise

(mg/dL/min)

OffOffLow | High (mins)

OffPredictive Alert

2:000:20Alert Repeat

250 700:00

High(mg/dL)

Low(mg/dL)TIME

OnGlucose

Alerts

Notes

1 2 3

54

Threshold Suspend Alarm (MiniMed® 530G system only)

On _____________ mg/dL (60–90 mg/dL)

Off

Low Repeat

_____________ minutes (5 min–1 hour)Low Repeat is turned on to the default of 20 minuteswhen any Low Alert setting is programmed

High Repeat

_____________ minutes (5 min–3 hours)Default is set at 1 hour May need to increase to2 hours to minimize alerts

Low Glucose Alert

Start on ______________________(date)

On

Time Units

12 a m ________ mg/dL

__________ ________ mg/dL

__________ ________ mg/dL

__________ ________ mg/dL

Base settings on CareLink® data

Off

Low Predictive Alert

On __________ minutes (5–30 min)

Off

Fall Rate Alert

On __________ mg/dL/minute (1 1–5 0)

Off

High Glucose Alert

Start on _________________________(date)

On

Time Units

12 a m ________ mg/dL

__________ ________ mg/dL

__________ ________ mg/dL

__________ ________ mg/dL

Base settings on CareLink® data

Off

High Predictive Alert

On __________ minutes (5–30 min)

Off

Rise Rate Alert

On __________ mg/dL/minute (1 1–5 0)

Off

Fax to:

Patient Name: Date:

DOB:

Continuous Glucose Monitoring Initiation SettingsPRESCRIBER’S INSTRUCTIONS TO PATIENT

Yes, patient may adjust settings as necessary after initial use No, it is preferred that the patient not adjust settings without consulting prescriber

If patient cannot use abdomen*, I authorize use of alternate site(s) as medically necessary

Alternate site(s): __________________________________________________________________________________

Prescriber Name: __________________________________________________________________________________________

Prescriber Signature: ____________________________________________________ Date: ______________________________

Notes (optional):

*The clinical trials of sensor accuracy have been based on sensors inserted in the abdominal area. Sensor performance may differ when other insertion sites are used.

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22 References and Suggested Reading

References and Suggested Readings

References1 American Association of Clinical Endocrinologists Consensus Panel AACE Consensus Statement on Continuous Glucose

Monitoring Endocrine Practice 2010;(16)5:732-745

2 Hirsch, IB, Armstrong, D, Bergenstal, RM, et al Clinical Application of Emerging Sensor Technologies in Diabetes Management: Consensus Guidelines for Continuous Glucose Monitoring (CGM) Diabetes Technol Ther 2008;10(4)232-244

3 The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group Diabetes Care 2009;32(11)1947-1953

4 Bergenstal, RM, Tamborlane, WV, Ahmann, A Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes N Engl J Med 2010;363(4)311-320

5 Medtronic MiniMed MiniMed 530G System User Guide Northridge, CA; 2012

6 Mastrototaro, J, Welsh, JB, Lee, S Practical Considerations in the Use of Real-Time Continuous Glucose Monitoring Alerts J of Diabetes Sci and Technol 2010;4(3)733-739

7 Data on file Medtronic, Inc Diabetes, 18000 Devonshire Street, Northridge, CA

8 JDRF Study Group JDRF Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes: Research Design and Methods Diabetes Technol Ther 2008;10(4)310-320

Suggested Reading American Association of Clinical Endocrinologists Consensus Panel AACE Consensus Statement on Continuous Glucose Monitoring Endocrine Practice 2010;(16)5:732-745

American Diabetes Association Position Statement on Standards of Medical Care in Diabetes 2012 Diabetes Care 2012;35(suppl 1)S11-S63

Agrawal, P, Welsh, JB, Kannadr, B, Askari, S, Yang, Q, Kaufman, FR Usage and Effectiveness of the Low Glucose Suspend Feature of the Medtronic Paradigm Veo Insulin Pump J Diabetes Sci Technol 2011;5(5)1137-1141

Bode, BW, Kyllo, J, Kaufman, FR Pumping Protocol: A Guide to Insulin Pump Therapy Initiation Northridge, CA: Medtronic, Inc Diabetes; 2012

Buckingham, B, Wilson, DM, Lecher, T, Hanas, R, Kaiserman, K, Cameron, F Duration of Nocturnal Hypoglycemia Before Seizures Diabetes Care 2008;31(11)2110-2112

Choudhary, P, Shin, J, Yongyin, W, et al Insulin Pump Therapy with Automated Insulin Suspension in Response to Hypoglycemia Diabetes Care 2011;34;2023-2025

Danne, T, Kordonouri, O, Holder, M, et al Prevention of Hypoglycemia by using Low Glucose Suspend Function in Sensor-Augmented Pump Therapy Diabetes Tech Ther 2011;13(11)1129-2025

Garg, S, Brazg, RL, Bailey, TS, et al Reduction in Duration of Hypoglycemia by Automatic Suspension of Insulin Delivery: The In Clinic ASPIRE Study Diabetes Technol Ther 2012;14(3)205-209

Hirsch, IB Realistic Expectations and Practical Use of Continuous Glucose Monitoring for the Endocrinologist J Clin Endocrinol Metab 2009;94(7)2232-2238

The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Tamborlane, WV, Beck, RW, Bode, BW, et al Continuous Glucose Monitoring and intensive Treatment of Type 1 Diabetes N Engl J Med 2008;359(14)1464-1476

Kaufman, FR Insulin Pumps and Continuous Glucose Monitoring: A User’s Guide to Effective Diabetes Management Alexandria, VA American Diabetes Association 2012

Mastrototaro, J, Welsh, JB, Lee, S Practical Considerations in the Use of Real-Time Continuous Glucose Monitoring Alerts J of Diabetes Sci Tech 2010;4(3)733-739

Phillip, M, Danne, T, Schlomt S, et al for the Consensus Form Participants ISPAD Consensus Statement on Use of Continuous Glucose Monitoring in Children and Adolescents Pediatric Diabetes 2012;13:215-228

23Notes

Notes

24 Notes

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Medtronic, Inc. | Diabetes 18000 Devonshire Street Northridge, CA 91325 USATel: 1.800.646.4633

www.MedtronicDiabetes.com

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