An in depth view of CGM and FSM technology. Focusing on product knowledge, companies finical profile, healthcare physician reimbursement, adverse events, mitigation of adverse events, and future needle free CGM technology.

1. Development of Continuous
Glucose Monitors (CGM) and
Advancement of Flash Glucose
Monitors (FGM)
David L. Loeser
Northeastern University
RGA6205 – Spring 2017

2. Table of Contents
 Electronic Glucose Monitoring Milestones……………………………………………………………………….………………………. Slide 3
 The Three Main CGM Competitors and Their First CGM FDA Approved Device………………….. Slide 4
 CGM and FMG - Technology and Functionality……………………………………………………………………………….……. Slide 5
 Understanding the Technology That Makes the Abbott Libre a Flash Device…………………………. Slide 6
 Abbott Libre Pro, Abbott Libre and Dexcom G5 Practical Usage Comparison……………………….. Slide 7
 Dexcom G5 Mobile System and Abbott Libre Technical Comparison…………………………………………. Slide 8
 CGM Patient Risk, Risk Mitigation, Recalls, Adverse Events………………………………………………………….. Slide 9
 Dexcom – Company Profile……………………………………………………………………………………………………………………………... Slide 10
 Abbott Laboratories – Company Profile………………………………………………………………………………………………………. Slide 11
 CGM Technology Bridges Patients and Healthcare Professionals Resulting in Efficient Diseases
Management and Improved Outcomes……………………………………………………………………………………………………… Slide 12
 Reimbursement and Coverage……………………………………………………………………………………………………………………… Slide 13
 Advanced Emerging Needle Free CGM Technology………………………………………………………………………….. Slide 14
 References…………………………………………………………………………………………………………………………………………………………….… Slide 15

3. Electronic Glucose Testing - Milestones
CFR 862.1345 – Glucose Test System
Device Class 2
Product Code (S) LFR, CGA, CFR, NBW
1974 Boehringer Mannheim (BM) introduces the Reflomat
Approval pathway 510(K)
510(K) Number K761148
Decision Date February 11, 1977
1984 BM introduces the Reflocheck & Glucose Test Strip System
Approval pathway 510(K)
510(K) Number K834271
Decision Date February 13, 1984
1989 Johnson & Johnson (Lifescan) introduces the One Touch II
Approval pathway 510(K)
510(K) Number K895911
Decision Date November 8, 1989

4. The Three Main CGM Competitors and Their First FDA Approved Device
CFR Unclassified
Device Class 3
Product Code MDS
First FDA approved Continuous Glucose Monitor (CGM)
1997 Medtronic introduces the MiniMed Continuous Glucose Monitoring System
Approval pathway PMA
PMA Number P980022
Decision Date June 15, 1999
Hardwired from sensor to receiver
2005 Abbott introduces the FreeStyle Navigator Continuous Glucose Monitor System
Approval pathway PMA
PMA Number P050020
Decision Date March 12, 2008
Wireless: Bluetooth
2005 Dexcom introduces the DexCom STS Continuous Glucose Monitoring System
Approval pathway PMA
PMA Number P050012
Decision Date March 24, 2006
Wireless: Bluetooth

5. CGM and FGM – Functionality and Technology
A Continuous Glucose Monitor (CGM) and Flash Glucose Monitor (FGM) are not devices that deliver insulin or can
correct blood sugar levels. They are diabetic disease management tools.
Basic Functionality of a CGM and FGM
• Reads glucose level every 5 minutes
• Can provide instant feedback allowing user to adjust and correct dietary and medical needs.
• In depth understanding of how an individuals body is utilizing the intake of carbohydrates. i.e 4 grams of
carbohydrates might raise blood sugar level 12 points
• Previously this would have required finger sticking every five minutes, a painful procedure.
• In depth understanding of how to correct glucose levels. i.e. A user might be hyperglycemic > 150 mg/dl
and can correct by taking the exact amount of insulin units to return back into normal range < > 80-150
mg/dl
• This prevents overcorrecting and entering into a hypoglycemic event < 80 mg/dl
Basic Technology of a CGM – Dexcom G5 Mobile CGM System
• A CGM is considered a device when all necessary parts are working in harmony,
each part is dependent upon the other
• Sensor - Worn on the body, a filament is inside the body, non reusable with
a lifespan of 7 – 14 days, waterproof (dependent to transmitter)
• Transmitter – Clips into the sensor and is reusable utilizing a battery with a
lifespan of 90 days, waterproof (dependent to transmitter)
• Receiver – Can be a smartphone with a proprietary application or a specific
reader developed by the manufacture, not waterproof. An iOS device can
be used as a receiver, Android application is currently under FDA review.
(dependent to both sensor and transmitter, Bluetooth BLE)
Basic Technology of a FGM – Abbott Libre and Libre Pro
• A FGM is considered a device when all necessary parts are working in harmony, however each part is not dependent with each other
• Sensor and Transmitter – Both are fused together, a filament is inside the body, non reusable with a lifespan of 14 days, waterproof
• Receiver – Can be a smartphone with a proprietary application or a specific reader developed by the manufacture, there are also
numerous mobile application that can be used allowing for even more precise measurements specific to the user (no dependence
to sensor and transmitter, Near Field Communication NFC)

6. 3 Functions of Near Field Communication - NFC
Read / Write Privileges
i.e. using an NFC enabled reader or smartphone to tap an NFC tag, reading
the instructions or data off the tag. Some NFC tags have write privileges, i.e.
program an NFC tag tap to turn on the lights to your house.
Peer to Peer
i.e. two smartphones tapping each other passing contact information or
files
Card Emulation
i.e. using a smartphone to make a payment at a grocery store register
Understanding the Technology That Makes the Abbott Libre a Flash Device
Flash technology refers to Near Field Communication (NFC)
• Allows for an instant reading from sensor to receiver
• Multiple layers of security
• Abbott Libre can only be started one time using the reader
• Abbott Libre has read privileges only, it is impossible to write new programing code to the sensor
• It is impossible to sniff data off the sensor
• Readings are only possible by “tapping” reader to sensor
• Reader and tapping are within one inch of each other, there is no data moving over the air
• ”Tapping” is possible through multiple layers of clothing
Abbott Libre NFC enabled reader
Abbott Libre NFC enabled sensor
NFC Tag
* iPhones come equipped with NFC technology locked for any other purpose other then ApplePay

7. Abbott Libre Pro, Abbott Libre and Dexcom G5 Practical Usage Comparison
Abbott Libe Pro is a ”blind” CGM
FDA approved, P150021. Currently being rolled out to physicians and diabetic educators
• Only available from a physician
• Patients can not scan the sensor
• 14 days of readings stored on the sensor
• Patients are encourage to keep daily logs for data comparison, fingersticks recordings
• Designed to assist in precision disease management and not a daily disease management tool
Abbott Libre
EU approved, CE Mark
• EU approved to replace fingersticking!
• The Libre has become very popular with parents of Type 1 children, they can take a reading without waking or
fingersticking
• UK specific; licensed auto drivers are advised to take a glucose reading two hours before and every two hours of driving
• The Libre is the most convenient way to take a glucose reading, an NFC “tapping” can be don’t without distraction to
automotive activity
• Previously drivers would have to stop all activity and fingerstick
• Only available for purchase directly from Abbott
• Abbott is not accepting new patients, popularity and demand have made it difficult fulfilling orders
• Current customer can order eight sensor per order (112 days of usage)
• This has led to a flood of sensors on eBay, and making it possible for US diabetics to acquire readers and sensors
Dexcom G5
FDA Approved, P120005
EU approved Android mobile application, under FDA review
• Not available as an over the counter product at this time
• Popular with recently diagnosed diabetics and the Do it Yourself community
• Utilizes Bluetooth technology, Dexcom allows a limit of 4 people to follow a user
• The Do it Yourself community has discovered that using 1 of the 4 followers they can develop unlimited applications
• Dexcom is a strong supporter of the DIY community, hosting hackathons, partnering with insulin pump startups to
develop artificial pancreas technology
• Improvement of product is valued by users. i.e. code name Archer is a single hand applicator designed to be less
intimidating and can fit in a pediatric users hand. Under current FDA review
• Brand new manufacturing facility in Mesa, AZ. All devices are to be manufactured in The United States

8. Dexcom G5 Mobile System and Abbott Libre Technical Comparison
Dexcom G5 Mobile CGM
System
Abbott Libre FGM Abbott Libre Pro FGM
FDA Approved Yes – P120005 Under Review Yes – P150021
FDA Device Class 3 3 3
FDA Pathway PMA PMA PMA
Pediatric Approved Yes Under Review Yes
Adult Approved Yes Under Review Yes
EU Approved Yes Yes Yes
Sensor Dimensions 1.5 x 0.9 x 0.5 inches 5mm high and 35mm diameter 5mm high and 35mm diameter
Operating Temperature 10° to 42° C 10° to 45° C 10° to 45° C
Sensor Weight 0.4 ounces 5 g 5 g
Sensor / Transmitter Battery 2 silver oxide batteries 1 silver oxide battery 1 silver oxide battery
Calibration Every 12 hours Factory Factory
Wireless Bluetooth NFC NFC
Waterproof IP28: 8 ft. up to 24 hours IP27: 3 ft. up to 30 mins IP27: 3 ft. up to 30 mins
Sensor Life 7 Days 14 Days Days
Residual Data 3 Hours 8 Hours (32 readings) 14 Days
Proprietary Mobile Application
iPhone
FDA Approved N/A N/A
Proprietary Mobile Application
Android
Under FDA Review, EU
Approved
Under FDA Review N/A
Ability to Share Data From Dexcom servers and 3rd
party mobile applications
From 3rd party mobile
applications
N/A
Ability to Utilize Data for
OpenAps
From Dexcom servers and 3rd
party mobile applications
From 3rd party mobile
applications
N/A

9. CGM Patient Risk, Risk Mitigation, Recalls, Adverse Events
Dexcom G5 safety and effectiveness list the following as a risk
• Sensor and adhesive patch
• Infection, inflation, pain or discomfort, bleeding at glucose sensor insertion site, bruising, itching, scarring, hematoma,
tape irritation, sensor or needle fracture during insertion, wear or removal
• Missed alerts
• False alerts
• False negative hypoglycemia and hyperglycemic reading
• Readings can be outside of the allowable standard deviation of + / - 20
Mitigating errors with CGM technology
• It will forever be the golden standard of a glucose reading is a fingerstick test
• Dexcom recommends calibrating every 12 hours
• If device is too far outside of standard device then do 3 calibration fingerstick tests each 15 minutes apart
• Abbott Libre is unique when it comes to reading errors, it is EU approved to replace fingerstick tests, and is under FDA review to
replace fingerstick test. However if there is any question the gold standard fingerstick test will always be recommend
Recalls
2007 – 2017 There have only been five recalls in total
• Class 1 device recall Dexcom G4/G5 Platinum Receiver – February 23, 2016
• Dexcom notified all customers by certified mail and email that “they may not receive an intended audible alarm or alert if
relying on hearing the alarm or alert. As a result customers may not detect a sever hypoglycemic or hyperglycemic event.”
• Number of devices effected: 53,106
• Class 2 device recall Freestyle Navigator CGM System – April 14, 2009
• Abbott notified all FreeStyle Navigator customers by certified main and posted on their website that there was potential
failure or inaccurate readings – the devices plastic housing near the battery compartment may crack, and allow moisture to
enter
• Number of devices effected: 5,449
Top Ranking Adverse Events
Device Problems Number of Events
Device display error message 41853
Wireless communication issue 35725
Invalid Sensing 21896
Total Device Problems (MDS) 173,337

10. Dexcom – Company Profile
CGM Product: G5 Mobile Glucose Monitor
CGM Products in Development: G5X, G6
Recent FDA Approvals: Supplement to original G5 approval of a new touchscreen receiver
Founded: 1999
Number of Employees: 1,900
Headquarter Location: San Diego, CA
Manufacturing Location: Mesa, AZ
Primary Competitors Developing Similar Technology: Abbott, Medtronic
Public company listed on Nasdaq
Symbol: DXCM
Income Statement*
Revenue 2016 2015 2014
Total Revenue 573,300 402,000 259,200
Cost of Revenue 194,900 123,600 82,900
Gross Profit 378,400 278,400 176,300
Stock Price History
Beta 0.58
52-Week Range 13.90%
S&P500 52-Week Change 16.24%
52 Week High 96.38
52 Week Low 57.68
50 Day Moving Average 77.46
200 Day Moving Average 73.80
Valuation Measures
Market Cap (intraday) 6.15B
* All numbers in thousands

11. Abbott Laboratories – Company Profile
CGM Product: Libre, Libre Pro
Founded: 1888
Number of Employees: 75,000
Headquarter Location: North Chicago, IL
Manufacturing Location: Global
Primary Competitors Developing Similar Technology: Dexcom, Medtronic
Public company listed on the NYSE
Symbol: ABT
Income Statement*
Revenue 2016 2015 2014
Total Revenue 20,853,000 20,405,000 20,247,000
Cost of Revenue 9,024,000 8,747,000 9,218,000
Gross Profit 11,829,000 11,658,000 11,029,000
Stock Price History
Beta 1.54
52-Week Range 15.14%
S&P500 52-Week Change 16.24%
52 Week High 45.84
52 Week Low 36.76
50 Day Moving Average 43.97
200 Day Moving Average 41.97
Valuation Measures
Market Cap (intraday) 76.13B
* All numbers in thousands

12. CGM Technology Bridges Patients and Healthcare Professionals
Resulting in Efficient Diseases Management and Improved Outcomes
Dexcom has a mobile and desktop application, Clarity, specifically designed to be used with healthcare
professionals
• Data can be viewed from any smartphone device and has no geographical boundaries
• Allows a healthcare physician to utilize telehealth technology
• Allows instant communication, correction and advisement between patient and healthcare
professionals
• Allows an endocrinologist to view
User Story:
If a patient is unresponsive they can include a dedicated code (dedicated emergency only) on their ID
allowing emergency and ambulance staff to view all data. Ambulance crew can quickly identify from current
Dexcom reading, Clarity data and finger stick to determine correct treatment. If patient is hypoglycemic a
Glucagon injection would be delivered pre admission. (Dexcom is currently improving Clarity to email a
patients endocrinologist that their data has been accessed by emergency personnel.)

13. Reimbursement and Coverage
• In 2017 CMS approved coverage for therapeutic CGM
• Therapeutic CGM is defined as a systems that are approved for use in making
diabetic treatment decisions without a fingerstick
• Dexcom G5 CGM is the only therapeutic CGM system covered by
Medicare
• Abbott Libre will be a therapeutic CGM system, under current FDA review
• In The United States all major insurance companies will reimburse under durable
medical equipment coverage
• Dedicated CGM technology billing codes
• Current Procedural Terminology Codes (CTP) as defined by the The
American Medical Association (AMA)
• Dedicated evaluation and management (E/M) billing codes as defined by
CMS
Codes Description Who Can Bill
E/M codes 99212-99215 Office visit for the evaluation and
management of an established
patient
Physicians, Physicians Assistants,
Nurse Practitioner
CPT Code 95250 • Sensor Placement
• Hoop-up and calibration (Libre is
factory calibrated)
• Sensor Removal and Printout of
Recording
Any qualified staff member under the
direct supervision of a physician, a
physician assistant, or a nurse
practitioner
CPT Code 92521 CGM Data Interpretation Physician, Physician Assistants,
Nurse Practitioners

14. Advanced Emerging Needle Free CGM Technology
Nemaura Medical
Number of Employees: 4
Headquarters Location: United Kingdom, Loughborough Science Park
Device Name: SugarBeat
• Worlds first needle-free, reusable CGM
• Utilizes a daily-disposable adhesive skin-patch
• Flexible
• Utilizes Bluetooth
• Applications for Android and iOS
• Separate reader can be used
Regulatory pathway: CE mark EU approved 2017
• Expected product launch in Europe, Asia and the Middle East late 2017
• Unknown if under FDA review
How SugarBeat Works
• By using positive and negative ions it draws a
glucose molecule to the senor converting the
molecule into a glucose reading
• The reading is then transmitted to an Android, iOS or
receiver

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References