what is cgm - amazon s3€¦ · the web-based dexcom clarity™ software is intended for use by...

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2:15 65% 100 200 300 400 40 1 PM 12 PM 102 mg/dL 102 mg/dL 102 mg/dL 102 mg/dL 2:15 65% 100 200 300 400 40 1 PM 12 PM 102 mg/dL mg/dL 102 102 mg/dL 400 300 250 150 200 100 350 2:15 PM 12 PM 11 AM 1 PM 1 2 3 1 2 3 A1C + 24 hours/day U P T O 2 8 8 R E A D I N G S A D A Y E V E R Y 5 M I N U T E S References 1 Dexcom G5 Mobile CGM System User Guide. 2 2015 AACE/ACE Guidelines. Endocr Pract. 2015; 21. Vol 21 (5) pg. 522-533. 3 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes, N Engl J Med. 2008: 359(14); 1464-1476. 4 Choudhary P, Ramasamy S, Green L et al. Real-Time Continuous Glucose Monitoring Significantly Reduces Severe Hypoglycemia in Hypoglycemia-Unaware Patients With Type 1 Diabetes. Diabetes Care. 2013;36(12):4160-4162. 5 Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011;34(4):795-800. BRIEF SAFETY STATEMENT: The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. CONTRAINDICATIONS: Remove the System before MRI, CT scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the System into the MR environment. Taking acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. WARNING: Do not use the System for treatment decisions. The System does not replace a blood glucose meter. The System is not approved for use in pregnant women, persons on dialysis or critically ill persons. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have infection or inflammation. Report broken sensors to Dexcom Technical Support. Sensor placement is not approved for sites other than under the skin of the belly (ages 2 years and older) or upper buttocks (ages 2-17 years). Your smart device’s internal settings override your app settings. Accessory devices (like a smart watch) might override your smart device’s alert and notification settings. The Share feature must be turned “On” with an active internet connection to communicate glucose information to a Follower. The Follower must download and install the Dexcom Follow App onto a separate smart device with an active internet connection to receive data. Contact Dexcom Toll Free at 877-339-2664 or www.dexcom.com for detailed indications for use and safety information. The web-based Dexcom CLARITY™ software is intended for use by both home users and healthcare professionals to assist people with diabetes in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities. Caution: The software should not be relied on for medical advice. Home users must consult a Healthcare Professional before making any medical interpretation and therapy adjustments from the information in these Reports. The software does not provide any medical advice and should not be used for that purpose. Healthcare professionals should use information form the software in conjunction with other clinical information available to them. ©2016 Dexcom, Inc. All rights reserved. LBL013927 Rev001 WHAT IS CGM ? Continuous Glucose Monitoring Continuous Glucose Monitoring is an FDA-approved system that displays dynamic information about glucose direction and speed, giving users additional insight to help with diabetes management. SPEED DIRECTION BGM displays a single number CGM displays a number, speed and direction of glucose NUMBER Blood Glucose Meter (BGM) vs. CGM CGM gives you more insight. With the additional information from CGM about glucose, speed and direction, a person may decide to eat a snack to avoid a hypoglycemic event †† , whereas they may not have taken action based on the BGM reading alone. Daily activities including meals and exercise, and other factors such as illness can impact glucose levels. CGM data can reveal what’s happening between fingersticks. †† Always use a BGM for treatment decisions The Simplicity of CGM Easy Patient Onboarding You prescribe CGM, and Dexcom will verify insurance coverage, and provide training, and more. Dexcom CLARITY Quickly gain clinically relevant insights through this web-based tool, including estimated A1C, historic glycemic variability, and time in range. Assess key glycemic patterns and contributing factors. Value to Your Practice • CGM usage can reduce your patients’ A1C levels, leading to improved performance metrics such as HEDIS scores. • Bill for patient training and interpretation. Insurance Coverage • CGM is covered by 98% of commercial insurance carriers. AACE/ACE CGM Guidelines The 2015 AACE/ACE Consensus Statement on CGM 2 recommends that: • All patients with type 1 diabetes should use CGM • CGM should be offered to all type 2 diabetes patients on multiple insulin injections, basal insulin, or sulfonylureas • CGM should also be used in patients at risk for hypoglycemia and/or have hypoglycemia unawareness Benefits to Patients Reduction of A1C without increasing risk for hypoglycemia 3 (JDRF landmark trial) Reduction of severe hypoglycemic incidents 4 and time spent in hypoglycemia by 50% 5 Support for nocturnal events: the built- in hypo alarm and customizable alerts can warn patients of dangerous events that may go unnoticed using BGM alone The Dexcom G5 ® Mobile Continuous Glucose Monitoring System (CGM) 1 The Dexcom G5 Mobile CGM System consists of three components: Sensor: Measures interstitial glucose levels just underneath the skin. Transmitter: Fastened on top of sensor; sends data wirelessly to a display device. The Dexcom G5 Mobile CGM System is: • Indicated for patients 2 years and older with diabetes. • An adjunctive device and does not replace a blood glucose meter. • Requires a prescription. SENSOR TRANSMITTER RECEIVER Display Device: Glucose data and trends can be displayed either on the Dexcom G5 Mobile Receiver or a compatible smart device.* Frequent Readings Data Sharing: Via the Dexcom G5 Mobile App, users can share their glucose information with up to five individuals for added support. (Requires the Dexcom Follow App*) Alerts & Alarms: Alerts including a built-in hypo alarm (55 mg/dL) warn of glucose highs and lows, allowing user to take appropriate action. FEATURES COMPATIBLE SMART DEVICE* 3 *For a list of compatible devices, visit www.dexcom.com/compatibility. Dexcom Receiver is part of the System; smart device sold separately.

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2:15 65%

100

200

300

400

401 PM 12 PM

102mg/dL

102mg/dL

102mg/dL

102mg/dL

17x22 poster

2:15 65%

100

200

300

400

401 PM 12 PM

102mg/dLmg/dL102102 mg/dL

400

300250

150200

100

350

2:15 PM12 PM11 AM 1 PM

1

2

3

12

3

A1C

+–

24hours/day

UP TO 288 READ

ING

S A DAY

EVERY 5 M

INU

TES

References1 Dexcom G5 Mobile CGM System User Guide. 2 2015 AACE/ACE Guidelines. Endocr Pract. 2015; 21. Vol 21 (5) pg. 522-533. 3 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes, N Engl J Med. 2008: 359(14); 1464-1476. 4 Choudhary P, Ramasamy S, Green L et al. Real-Time Continuous Glucose Monitoring Significantly Reduces Severe Hypoglycemia in Hypoglycemia-Unaware Patients With Type 1 Diabetes. Diabetes Care. 2013;36(12):4160-4162. 5 Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011;34(4):795-800.

BRIEF SAFETY STATEMENT: The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. CONTRAINDICATIONS: Remove the System before MRI, CT scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the System into the MR environment. Taking acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. WARNING: Do not use the System for treatment decisions. The System does not replace a blood glucose meter. The System is not approved for use in pregnant women, persons on dialysis or critically ill persons. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have infection or inflammation. Report broken sensors to Dexcom Technical Support. Sensor placement is not approved for sites other than under the skin of the belly (ages 2 years and older) or upper buttocks (ages 2-17 years). Your smart device’s internal settings override your app settings. Accessory devices (like a smart watch) might override your smart device’s alert and notification settings. The Share feature must be turned “On” with an active internet connection to communicate glucose information to a Follower. The Follower must download and install the Dexcom Follow App onto a separate smart device with an active internet connection to receive data. Contact Dexcom Toll Free at 877-339-2664 or www.dexcom.com for detailed indications for use and safety information.

The web-based Dexcom CLARITY™ software is intended for use by both home users and healthcare professionals to assist people with diabetes in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities. Caution: The software should not be relied on for medical advice. Home users must consult a Healthcare Professional before making any medical interpretation and therapy adjustments from the information in these Reports. The software does not provide any medical advice and should not be used for that purpose. Healthcare professionals should use information form the software in conjunction with other clinical information available to them.

©2016 Dexcom, Inc. All rights reserved. LBL013927 Rev001

WHAT IS CGM?Continuous Glucose Monitoring

Continuous Glucose Monitoring is an FDA-approved system that displays dynamic

information about glucose direction and speed, giving users additional insight to help with

diabetes management.

SPEED

DIRECTION

BGM displays a

single number

CGM displays a number,

speed and direction

of glucose

NUMBER

Blood Glucose Meter (BGM) vs. CGM

CGM gives you more insight. With the additional information from CGM about glucose, speed and direction, a person may decide to eat a snack to avoid a hypoglycemic event††, whereas they may not have taken action based on the BGM reading alone. Daily activities including meals and exercise, and other factors such as illness can impact glucose levels. CGM data can reveal what’s happening between fingersticks.††Always use a BGM for treatment decisions

The Simplicity of CGM Easy Patient OnboardingYou prescribe CGM, and Dexcom will verify insurance coverage, and provide training, and more.

Dexcom CLARITY™ Quickly gain clinically relevant insights through this web-based tool, including estimated A1C, historic glycemic variability, and time in range. Assess key glycemic patterns and contributing factors.

Value to Your Practice• CGM usage can reduce your patients’ A1C

levels, leading to improved performance metrics such as HEDIS scores.

• Bill for patient training and interpretation.

Insurance Coverage• CGM is covered by 98% of commercial

insurance carriers.

AACE/ACE CGM GuidelinesThe 2015 AACE/ACE Consensus Statement on CGM2 recommends that:

• All patients with type 1 diabetes should use CGM

• CGM should be offered to all type 2 diabetes patients on multiple insulin injections, basal insulin, or sulfonylureas

• CGM should also be used in patients at risk for hypoglycemia and/or have hypoglycemia unawareness

Benefits to Patients Reduction of A1C without increasing risk for hypoglycemia3 (JDRF landmark trial)

Reduction of severe hypoglycemic incidents4 and time spent in hypoglycemia by 50%5

Support for nocturnal events: the built-in hypo alarm and customizable alerts can warn patients of dangerous events that may go unnoticed using BGM alone

The Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM)1

The Dexcom G5 Mobile CGM System consists of three components:

Sensor: Measures interstitial glucose levels just underneath the skin.

Transmitter: Fastened on top of sensor; sends data wirelessly to a display device.

The Dexcom G5 Mobile CGM System is:

• Indicated for patients 2 years and older with diabetes.

• An adjunctive device and does not replace a blood glucose meter.

• Requires a prescription.SENSOR

TRANSMITTER

RECEIVER†

Display Device: Glucose data and trends can be displayed either on the Dexcom G5 Mobile Receiver or a compatible smart device.*

FrequentReadings

Data Sharing:Via the Dexcom G5 Mobile App,

users can share their glucose information with up to five

individuals for added support. (Requires the

Dexcom Follow App*)

Alerts & Alarms: Alerts including a built-in

hypo alarm (55 mg/dL)warn of glucose highs

and lows, allowing user to take appropriate

action.

FEATURES

COMPATIBLE SMART DEVICE*†

3

*For a list of compatible devices, visit www.dexcom.com/compatibility. †Dexcom Receiver is part of the System; smart device sold separately.

2:15 65%

100

200

300

400

401 PM 12 PM

102mg/dL

102mg/dL

102mg/dL

102mg/dL

17x22 poster

2:15 65%

100

200

300

400

401 PM 12 PM

102mg/dLmg/dL102102 mg/dL

400

300250

150200

100

350

2:15 PM12 PM11 AM 1 PM

1

2

3

12

3

A1C

+–

24hours/day

UP TO 288 READ

ING

S A DAY

EVERY 5 M

INU

TES

References1 Dexcom G5 Mobile CGM System User Guide. 2 2015 AACE/ACE Guidelines. Endocr Pract. 2015; 21. Vol 21 (5) pg. 522-533. 3 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes, N Engl J Med. 2008: 359(14); 1464-1476. 4 Choudhary P, Ramasamy S, Green L et al. Real-Time Continuous Glucose Monitoring Significantly Reduces Severe Hypoglycemia in Hypoglycemia-Unaware Patients With Type 1 Diabetes. Diabetes Care. 2013;36(12):4160-4162. 5 Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011;34(4):795-800.

BRIEF SAFETY STATEMENT: The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. CONTRAINDICATIONS: Remove the System before MRI, CT scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the System into the MR environment. Taking acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. WARNING: Do not use the System for treatment decisions. The System does not replace a blood glucose meter. The System is not approved for use in pregnant women, persons on dialysis or critically ill persons. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have infection or inflammation. Report broken sensors to Dexcom Technical Support. Sensor placement is not approved for sites other than under the skin of the belly (ages 2 years and older) or upper buttocks (ages 2-17 years). Your smart device’s internal settings override your app settings. Accessory devices (like a smart watch) might override your smart device’s alert and notification settings. The Share feature must be turned “On” with an active internet connection to communicate glucose information to a Follower. The Follower must download and install the Dexcom Follow App onto a separate smart device with an active internet connection to receive data. Contact Dexcom Toll Free at 877-339-2664 or www.dexcom.com for detailed indications for use and safety information.

The web-based Dexcom CLARITY™ software is intended for use by both home users and healthcare professionals to assist people with diabetes in the review, analysis, and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities. Caution: The software should not be relied on for medical advice. Home users must consult a Healthcare Professional before making any medical interpretation and therapy adjustments from the information in these Reports. The software does not provide any medical advice and should not be used for that purpose. Healthcare professionals should use information form the software in conjunction with other clinical information available to them.

©2016 Dexcom, Inc. All rights reserved. LBL013927 Rev001

WHAT IS CGM?Continuous Glucose Monitoring

Continuous Glucose Monitoring is an FDA-approved system that displays dynamic

information about glucose direction and speed, giving users additional insight to help with

diabetes management.

SPEED

DIRECTION

BGM displays a

single number

CGM displays a number,

speed and direction

of glucose

NUMBER

Blood Glucose Meter (BGM) vs. CGM

CGM gives you more insight. With the additional information from CGM about glucose, speed and direction, a person may decide to eat a snack to avoid a hypoglycemic event††, whereas they may not have taken action based on the BGM reading alone. Daily activities including meals and exercise, and other factors such as illness can impact glucose levels. CGM data can reveal what’s happening between fingersticks.††Always use a BGM for treatment decisions

The Simplicity of

Easy Patient OnboardingYou prescribe CGM, and Dexcom will verify insurance coverage, and provide training, and more.

Dexcom CLARITY™ Quickly gain clinically relevant insights through this web-based tool, including estimated A1C, historic glycemic variability, and time in range. Assess key glycemic patterns and contributing factors.

Value to Your Practice• CGM usage can reduce your patients’ A1C

levels, leading to improved performance metrics such as HEDIS scores.

• Bill for patient training and interpretation.

Insurance Coverage• CGM is covered by 98% of commercial

insurance carriers.

AACE/ACE CGM GuidelinesThe 2015 AACE/ACE Consensus Statement on CGM2 recommends that:

• All patients with type 1 diabetes should use CGM

• CGM should be offered to all type 2 diabetes patients on multiple insulin injections, basal insulin, or sulfonylureas

• CGM should also be used in patients at risk for hypoglycemia and/or have hypoglycemia unawareness

Benefits to Patients Reduction of A1C without increasing risk for hypoglycemia3 (JDRF landmark trial)

Reduction of severe hypoglycemic incidents4 and time spent in hypoglycemia by 50%5

Support for nocturnal events: the built-in hypo alarm and customizable alerts can warn patients of dangerous events that may go unnoticed using BGM alone

The Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM)1

The Dexcom G5 Mobile CGM System consists of three components:

Sensor: Measures interstitial glucose levels just underneath the skin.

Transmitter: Fastened on top of sensor; sends data wirelessly to a display device.

The Dexcom G5 Mobile CGM System is:

• Indicated for patients 2 years and older with diabetes.

• An adjunctive device and does not replace a blood glucose meter.

• Requires a prescription.SENSOR

TRANSMITTER

RECEIVER†

Display Device: Glucose data and trends can be displayed either on the Dexcom G5 Mobile Receiver or a compatible smart device.*

FrequentReadings

Data Sharing:Via the Dexcom G5 Mobile App,

users can share their glucose information with up to five

individuals for added support. (Requires the

Dexcom Follow App*)

Alerts & Alarms: Alerts including a built-in

hypo alarm (55 mg/dL)warn of glucose highs

and lows, allowing user to take appropriate

action.

FEATURES

COMPATIBLE SMART DEVICE*†

3

*For a list of compatible devices, visit www.dexcom.com/compatibility. †Dexcom Receiver is part of the System; smart device sold separately.