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Qualcomm Life Connect 2013 - Terrance H. Gregg
 

Qualcomm Life Connect 2013 - Terrance H. Gregg

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

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

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    Qualcomm Life Connect 2013 - Terrance H. Gregg Qualcomm Life Connect 2013 - Terrance H. Gregg Presentation Transcript

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