How Continuous Glucose Monitoring is Transforming Diabetes Treatment

Terrance H. Gregg Chief Executive Officer, Dexcom Inc.

1999Founded

San Diego

DXCM

vv

4Generations ofContinuous Glucose Monitoring

* Dexcom/Edwards Lifesciences automated glucose monitoring system not yet FDA approved.

Strategic Relationships

Dexcom Background

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  

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%

#CONNECT2013

Transforming Diabetes Care With Continuous Glucose Monitoring …

Traditional Diabetes Self Management

BLOOD  GLUCOSE  METER  IN  PATIENT’S  POCKET  MANAGE  INSULIN  /  MEALS  /  EXERCISE  

REACT  TEST  /  ACQUIRE  DATA  

SELF  CARE  WITH  LIMITED  INFORMATION  

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

0

70

140

210

280

350

2 4 6 8 10 12 14 16 18 20 22 24 Time (Hours)

Glu

co

se (

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

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  

Real-time CGM is a Newer Addition to Diabetes Therapy

GlucoWatch (2001)

Dexcom STS (2006)

Medtronic Guardian Real-Time (2005)

Abbott Navigator (2007)

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

CGM System Components: Sensor, Transmitter & Receiver

Glucose Sensor

Receiver & Transmitter

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”  

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.

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

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

CGM GLUCOSE SENSORS

TO MEASURE GLYCEMIC

VARIABILITY

Data DATA MANAGEMENT FOR DRUG TRIALS

INCLUDES DIABETES DATA AND OTHER

BIOMETRICS

WIRELESS REMOTE MONITORING & DATA

CAPTURE

Mobile

Transforming Diabetes Drug Development

2net HUB ENABLES BROADER

UTILIZATION OF DEVICES

SUPPORTING  THE  USE  OF  DATA  TO  ADVANCE  DRUG  DEVELOPMENT  

Partial List of Companies Using CGM in Clinical Research

#CONNECT2013

Consumer Health in the Cloud Connectivity in Diabetes Care

Patients are driving demand

The Future is All About Connected Platforms

Connectivity*

CGM Integration*

Smartphone*

*Inves,ga,onal  Use  Only  

Stand-alone CGM

Integrating CGM Into Daily Life

*Inves,ga,onal  Use  Only  

Connectivity: Create Action from Data

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

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

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

How Can CGM Data Make a Difference?

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  

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  

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

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  

$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

We can Reduce Costs  

Benefit All Patients  Save Lives  

© 2013 Qualcomm Life. All rights reserved.

#CONNECT2013

Thank you

Terrance H. Gregg Chief Executive Officer, Dexcom, Inc.