Dexcom, Inc. CEO Terrance H. Gregg on how continuous glucose monitoring is transforming diabetes treatment.

1. How Continuous Glucose Monitoring
is Transforming Diabetes Treatment
Terrance H. Gregg
Chief Executive Officer, Dexcom Inc.

2. 1999
Founded
San Diego
DXCM
vv
4Generations of
Continuous Glucose Monitoring
* Dexcom/Edwards Lifesciences automated glucose monitoring system not yet FDA approved.
Strategic Relationships
Dexcom Background

3. US
26.8
M
ROW
344
M
Diabetes: A Global Epidemic
IDF
Es,mate
of
WW
Incidence
371M
(20-­‐79
years
of
age)
IDF
es,mates
552M
WW
by
2030
Source:
IDF Diabetes Atlas 5th edition, © International Diabetes Federation, 2012.
1.
Kleinfeld
N.R.
NYT,
"Diabetes
and
Its
Awful
Toll
Quietly
Emerge
as
a
Crisis"
1/9/2006
2.
Economic
Costs
of
Diabetes
in
the
U.S.
in
2007,
American
Diabetes
AssociaNon
Everyday
in
the
US1:
1
in
3
children
born
will
develop
diabetes
4,100
people
will
be
diagnosed
55
people
with
diabetes
will
go
blind
230
amputa,ons
will
be
performed
120
people
will
enter
treatment
for
kidney
failure
1
in
10
health
care
dollars
is
spent
trea,ng
diabetes2

4. US Health Care Expenditures for Diabetes in 2012
Institutional: inpatient & nursing home
$91 Billion
Medications, supplies
$53 Billion
$245 Billion in Total Costs
Average medical expenditures among people with diagnosed diabetes were
2.3 X higher
than what expenditures would be in the absence of diabetes
Economic Costs of Diabetes in the US in 2012, Diabetes Care. Published online ahead of print, March 6, 2013
Staggering Costs of Poor Control
Indirect Costs
$69 Billion
Outpatient care
$32 Billion
37%28%
13%
22%

5. #CONNECT2013
Transforming Diabetes Care
With Continuous Glucose Monitoring …

6. Traditional Diabetes Self Management
BLOOD
GLUCOSE
METER
IN
PATIENT’S
POCKET
MANAGE
INSULIN
/
MEALS
/
EXERCISE
REACT
TEST
/
ACQUIRE
DATA
SELF
CARE
WITH
LIMITED
INFORMATION

7. To effectively treat diabetes,
you must know where you are going…

8. 0
70
140
210
280
350
2 4 6 8 10 12 14 16 18 20 22 24
Time (Hours)
Glucose(mg/dl)
0
SMBG 4.2 Hours after
passing 210 mg/dl
Above 210 for
4.8 Hours
Dangerous Low
for 1 Hour
Above 140 for 13.5 Hours
Target Range
Target Range
Continuous Glucose Monitoring

9. If
all
you
had
was
a
finger
sRck
number,
what
decisions
would
you
make?
CGM Provides the Speed and Direction of Glucose Change
To Better Inform Decisions
Do
Nothing
Eat
Take
Insulin

10. Real-time CGM is a Newer Addition to Diabetes Therapy
GlucoWatch
(2001)
Dexcom STS
(2006)
Medtronic Guardian Real-Time
(2005)
Abbott Navigator
(2007)

11. Early Devices Were Either Inaccurate, Difficult to Use or Both
• Patient and health care
provider reaction to early
CGM systems was “mixed”
• Potential clinical benefit of
early real-time CGM
products were not as great
as had been expected
Early generations of CGM were a
bronze medal, not a gold

12. CGM System Components: Sensor, Transmitter & Receiver
Glucose
Sensor
Receiver & Transmitter

13. What Does Continuous Glucose Sensor Data Look Like?
Three 12-hour in-clinic glucose monitoring studies over seven days of use
Sample from Dexcom G4 PLATINUM Pivotal Study
Real-time CGM Feedback
• Patients use alerts and alarms
to “stay between the lines”

14. The Role of CGM in Reducing Costs
US payer with 5 million members:
Type 1 prevalence (.4%) +
T2 prevalence = 5.8% (27% on insulin)
20,000 T1 patients
78,300 T2 insulin using
98,300 insulin patients
20 % T1 with “hypo unawareness”1
10% T2 on insulin with “hypo unaware”2
4,000 T1 patients
7,830 T2 patients
11,830 patients
2.8 episodes of severe hypoglycemia/year3 33,124 episodes
21% require hospitalization4 6,956 hospitalizations
Cost per hospitalization5 @ $17,000
Total hospital costs: T1 and T2 insulin taking hypo unaware patients $118 Million
Costs of Hypoglycemia - Hospitalizations
CGM reduces hypoglycemia by nearly 50%6
1) Geddes J, et al Diabetes Medicine, 2008: 25:501-4. 2) Schopman JE et al Diab Res Clin Pract. 2010;87:64-8. 3) Gold AE, et al Diab Care, 1994; 17(7):697-703. 4) Leese GP,
Diab Care, 2003; 26(4):1176-80. 5) Quilliam BJ, et al Am Jrnl Managed Care, 2011: 17(10) 673-680. 6) JDRF Study Group Diab Care, 2010, 33(1): 17-22.

15. Importance of CGM in Diabetes Drug Trials
• With the use of CGM in clinical trials, glycemic variability can be measured and
this may be increasingly important in addition to the traditional A1C primary endpoint
• Potential to reduce costs for large Pharma trials with opportunity to facilitate the speed
of research (“fail fast” or demonstrate positive outcomes) from richer data sets
• Positive impact throughout the entire drug development lifecycle from pre-clinical research
to post market surveillance with glycemic variability and data management solutions

16. CGM Recommended for Diabetes Drug Development
EMA Published Guidelines for the Use of CGM in Diabetes Drug Trials (2013)
• Measures of Glycemic Control: Use of CGM is “encouraged” and regarded as useful in adults and children to
describe overnight glucose profiles and postprandial hyperglycemia
• Hypoglycemia. Use of continuous glucose monitoring, providing more complete information on night profiles,
should be considered, especially in patient groupsat increased risk for hypoglycemia
• Assessment of Efficacy. CGM should be considered
• Children. A1c is the recommended primary efficacy endpoint. Glycemic variability and hypoglycemic episodes are
important secondary endpoints. Both should be documented, preferably by continuous glucose measurements
• Safety Aspects – Hypoglycemia. In order to assess nocturnal hypoglycemia, the use of continuous glucose
monitoring devices should be considered. A relevant reduction of documented episodes of hypoglycemia,
particularly severe events, if studied in appropriately controlled trials, could support a claim of superiority
Definitions: EMA = European Medicines Agency

17. CGM
GLUCOSE SENSORS
TO MEASURE
GLYCEMIC
VARIABILITY
DataDATA MANAGEMENT
FOR DRUG TRIALS
INCLUDES DIABETES
DATA AND OTHER
BIOMETRICS
WIRELESS REMOTE
MONITORING & DATA
CAPTURE
Mobil
e
Transforming Diabetes Drug Development
2net HUB ENABLES
BROADER
UTILIZATION OF
DEVICES
SUPPORTING
THE
USE
OF
DATA
TO
ADVANCE
DRUG
DEVELOPMENT

18. Partial List of Companies Using CGM in Clinical Research

19. #CONNECT2013
Consumer Health in the Cloud
Connectivity in Diabetes Care

20. Patients are
driving demand

21. The Future is All About Connected Platforms
Connectivity*
CGM
Integration*
Smartphone*
*Inves,ga,onal
Use
Only
Stand-alone
CGM

22. Integrating CGM Into Daily Life
*Inves,ga,onal
Use
Only
Connectivity: Create Action from Data

23. Stanford/University of Virginia Study at Diabetes Camps This Summer
CGM connected to UVA Android phone*
“CAUTION: Limited by Federal (or United States) law to investigational use."
Remote monitoring of nocturnal hypoglycemia*
Remote Monitoring* in Artificial Pancreas Research
University of Virginia remote monitoring software adapted from closed
loop research

24. Components of Closed Loop Artificial Pancreas System
Continuous glucose
sensors
Control algorithms
Insulin pump
Role of control algorithms
INPUT:
CGM data stream, insulin on board
COMPUTATIONS:
metabolic model, equations
OUTPUT:
commands to insulin pump
Connectivity is a “Must Have” to Enable Safe Support

25. Charlie Kimball – INDYCAR Racecar Driver with T1D
Connected CGM Platform Fueling Digital Health for Professional Race Car Driver

26. How Can CGM Data Make a Difference?

27. 2net Ecosystem for Future Remote Care Models
Historical
Data
from
CGM
Historical
Data
Transfer
to
Secure
Server
Suppor,ng
the
use
of
data
to
advance
remote
care
models
Data
Received,
Verified,
Stored,
and
Transferred
2net
Hub
at
Home
Data
Access
Report
generated
for
care
providers*
*For
invesNgaNonal
use
only

28. Future Applications: Connected Care Models
CGM
Device
Connect
to
smartphone
Data
forwarded
to
iPad
or
tablet
Could
allow
populaRon
management
CGM
Data
TransmiXed
to
server
Data
displayed
on
PC,
tablet
or
a
parent’s
phone
*Inves,ga,onal
device
use
only

29. CGM Should Be Used First in Any Treatment Approach
Newly diagnosed patients
– How does a doctor decide on insulin dosage without
understanding the glucose profile?
For all insulin taking patients
– Method of insulin is not as important as knowing when and how
much to take
For all patients undergoing treatment & medication
adjustments
– For titration of insulin, oral medications, or lifestyle

30. The Business Model(s)
Today:
HCP
Office
Clinical
Trials/Research
Future:
Payors
/HCP
• Codes
exist
for
CGM
reimbursement
• Interpreta,on
of
CGM
(non
face
to
face)
reimbursement
differs
by
payor
• Fee
for
service
• Risk
sharing
models
based
on
outcomes
• Will
align
with
new
health
care
delivery
system
models
Today:
PaRents
• CGM
covered
by
most
commercial
insurance
providers

31. $0
$10,000,000
$20,000,000
$30,000,000
$40,000,000
$50,000,000
$60,000,000
$70,000,000
$80,000,000
$90,000,000
$100,000,000
2007 2008 2009 2010 2011
$4m
$8m
$18m
$40m
$66m
$93m*
2012
Dexcom Product Revenue Performance as CGM Technology Leader

32. We can
Reduce Costs
Benefit All Patients
Save Lives

33. © 2013 Qualcomm Life. All rights reserved.
#CONNECT2013
Thank you
Terrance H. Gregg
Chief Executive Officer, Dexcom, Inc.