Dexcom Current and Future Technology Innovations. Jorge Valdes Chief Technical Officer

Transcription

1 Dexcom Current and Future Technology Innovations 2015 Jorge Valdes Chief Technical Officer

2 G5 App Sensor (Same as G4) Indicated for adults and children down to Age 2 years Tiny insertion needle (26Ga) Seven day sensor life Transmitter No recharging required 6-Meter (20-foot) transmission range Built in BLE for direct transmission of CGM data to receiver and mobile device mmol/l System Receiver Alternative device to view data Slim modern profile with colors Customizable alerts +For a listing of compatible devices, visit

3 11.2 mmol/l

4 Discrete Glucose Alerts

5 Simplified Mobile Interface 11.2 mmol/l 2.8 mmol/l 8.3 mmol/l HIGH LOW GOOD TO GO

6 11.2 mmol/l + *For a listing of compatible devices, visit

7 G5 Mobile includes latest algorithm G4 PLATINUM and G5 Mobile System Accuracy versus YSI by In- Clinic Day over the Glucose Range mg/dl ( mmol/l) Day 1 Days 1-7 Study N MARD %20/20 N MARD %20/20 G4 PLATINUM OUS G5 Mobile G4 PLATINUM G5 Mobile System Accuracy versus YSI by In-Clinic Day over the Glucose Range mg/dl ( mmol/l) Study Day 1 Days 1-7 N MAD %20/20 N MAD %20/20 G4 PLATINUM OUS G5 Mobile Bailey et al. Clinical Accuracy of a Continuous Glucose Monitoring System with an Advanced Algorithm J Diabetes Sci Technol November 3, 2014

8 G5 Mobile- Accuracy is similar between pediatric and adult subjects G5 Accuracy versus YSI over the Glucose Range mg/dl ( mmol/l) Study Days 1-7 N MARD G5 Mobile Adults G5 Mobile Pediatrics During the youth s participation in the clinic session, the Dexcom CGM detected 91% (225/247) of low ( 80 mg/dl/4.4 mmol/l) YSI readings within 15 mins 97% (1038/1070) of high ( 200 mg/dl/11.1 mmol/l) YSI readings within15 mins Laffel et al. Performance of a New Continuous Glucose Monitoring System (CGM) in Youth ATTD 2015

9 Dexcom G5 Mobile CGM: Now for Decision Making!

10 Dexcom G5 Mobile CGM New CE Marked Indications for Use Indicated For The Management Of Diabetes In Persons Age 2 Years And Older. Designed To Replace Fingerstick Blood Glucose Testing For Diabetes Treatment Decisions. Interpretation of CGM Results Should Be Based On The Glucose Trends And Several Sequential Readings Over Time. Aids In The Detection Of Episodes Of Hyperglycemia And Hypoglycemia, Facilitating Both Acute And Long-term Therapy Adjustments.

11 Modifications to Safety Statements Diabetes Treatment Decisions If your Dexcom G5 does not display a sensor glucose reading or if you are getting inconsistent readings, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Do Not Ignore Low/High Symptoms Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do not match your symptoms or expectations, you should obtain a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions or seek immediate medical attention. Treatment Decisions Make diabetes treatment decisions based on the combination of the sensor glucose reading, trend arrow, trend graph, and/or actionable alerts generated by the Dexcom G5.

12 Using CGM Enables Better Decisions It is time for CGM based decision making

13 CGM is the Only Solution that Provides The Full Glucose Picture 4.4 mmol/l 4.3 mmol/l Meter test reflects in-control glucose Speed and direction plus alerts warn of a rapid decline enabling the patient to course correct to avoid an extreme low

14 Mean A1c CGM Use is Associated With Lower A1C Across All Ages of Type 1 Diabetes Patients 9.0% 8.9% 8.5% 8.4% 8.1% 8.0% 7.5% 7.8% 7.7% 7.3% Non CGM User CGM User 7.0% <13 (n = 3,050) (n = 6,855) >25 (n = 4,077) Age (years) Presented at T1D Exchange Meeting in April 2015 & drawn from Diabetes Care 2015; 38:

15 Mean A1C CGM is Associated with Lower A1C Regardless of Insulin Delivery Method 9.5% 9.3% Injection only 9.0% 8.5% 8.0% 8.7% 8.3% 7.9% 7.8% 8.6% 8.1% 8.0% 7.8% Pump only Injection + CGM Pump + CGM 7.5% 7.6% 7.2% 7.2% 7.0% <13 (n=3,050) (n=6,855) >25 (n=4,077) Age (years) 1) Presented at T1D Exchange Meeting in April 2015 & drawn from Diabetes Care 2015; 38:

16 Dexcom s Next Generation Sensor Reduced calibrations leading to factory calibration Maintain high level of accuracy No signal response to Acetaminophen "CAUTION--Investigational device. Limited by law to investigational use only."

17 Our world is changing Accelerating pace of innovation in the consumer world Empowerment of patients and parents, the diabetes online community and user innovation The increasing need to address costeffectiveness of solutions, and reduce societal cost

18 Dexcom ecosystem vision Amplify the value and utility of CGM data See the big picture Reflect together Support choice in diabetes management Pursue interoperability Facilitate customer experience Engage the innovation community Enable lead users

19 G5 Mobile Enables the Ecosystem 10.4 mmol/l

20 Amplify the value & utility of CGM data Reflect Food: together MealMemory from Databetes Exercise: TrainingPeaks from Peaksware

21 Amplify the value & utility of CGM data Stanford Connected Health Project Patient wearing CGM Provider communicates with patient securely via Epic MyChart CGM data passively sent to Apple Health App Data are visualized and assessed by provider Data passively conveyed to Epic MyChart app Data passively populates patient EHR for analytics and review Electronic Medical Records

22 Support choice in diabetes management Pursue interoperability with other medical devices Insulin pump partners with (mobile) computing platforms ios (HealthKit), Android; Mac, Windows Facilitate customer experience Compatibility with lifestyle and goals Wearables and more

23 Develop a simple, low-cost, disposable body-worn sensor system integrated into an advanced data analytics platform to drive entry into Type 2 market and to expand CGM use in Type1 market Partnership Objectives

24 Dexcom Clarity Patients see reports at home: Automatically from G5 Mobile Streaming App Via direct upload from G5, G4, and G4 Share receivers Clinicians see patient reports in their office: Anonymously via receiver upload With patient permission via a code SweetSpot Confidential 24

25 Overview Report Clinical relevance in a single page: User-chosen date range Statistics bar Estimated A1C Average glucose Hypoglycemia risk Time in range (selectable range) Average daily CGM calibrations Most important glucose patterns Nighttime lows Daytime lows Nighttime highs Daytime highs Includes best day SweetSpot Confidential 25

26 Patterns Report User-chosen date range One report for each identified pattern from the Overview: Nighttime lows Daytime lows Nighttime highs Daytime highs Includes best day Graphical examples of data that made up each pattern SweetSpot Confidential 26

27 Trends Report Clinical relevance in a graphical, modal day format, showing glucose trends at different times of day: User-chosen date range Filters allow more user selection for which kinds of data shown Color shading indicates clinically significant hyper- or hypoglycemia Most-significant areas are brighter Daytime & nighttime target glucose ranges, settable by users SweetSpot Confidential 27

28 Compare Report Compare glucose data from 2 userchosen date ranges to help identify improvement over time Modal day for each date range Statistics comparison section Arrows indicate change SweetSpot Confidential 28

29 Our Mission Best-in-class CGM experience Simple, welcoming out-of-box experience Reliable, usable, and helpful CGM Automated, friendly troubleshooting and support An ecosystem of tools for patients to make life simple and improve outcomes Integration with insulin systems, meal and activity tracking Retrospective patterns and insights Decision support