JDRF Type One Nation Research Summit Diabetes Technology: A Bridge to a Cure

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1 JDRF Type One Nation Research Summit Diabetes Technology: A Bridge to a Cure Kelly L. Close, president, Close Concerns editor-in-chief, diatribe March 1, 2014 closeconcerns.com Slide 1

2 We thank many researchers, scientists + funders

3 Outline About Us A snapshot of new and upcoming diabetes technology The artificial pancreas UVA s overnight closed-loop system The future of diabetes technology Slide 3

4 Outline About Us A snapshot of new and upcoming diabetes technology The artificial pancreas MGH / BU UVA s overnight closed-loop system The future of diabetes technology

5 About Us Close Concerns: founded in 2002 as a healthcare information company focused exclusively on diabetes Our mission: to improve patient outcomes by making everyone smarter about diabetes and obesity Providing a platform for young healthcare leaders is also incredibly important to us.

6

7 About Us diatribe: founded in 2006, a website for patient education. Our mission is to help people with diabetes become healthier and happier through education. diatribe is a non-profit supported by the Helmsley Charitable Trust and many others. Over 100,000 readers have visited the diatribe website over the last 18 months (www.diatribe.org)

8 Slide 8

9 About Us dq&a dq&a: founded in 2009, a market research company focused on diabetes and obesity. The mission is to help the diabetes industry understand the true voice of the patient and their healthcare team. dq&a works with a panel of 12,000 patients, interviewing them quarterly (now for 18 straight quarters). Also works with panels of educators and physicians, and provides custom research.

10 Outline About Us A snapshot of new and upcoming diabetes technology The artificial pancreas UVa s overnight closed-loop system The future of diabetes technology

11 Living with diabetes can and should provide you with the opportunity to celebrate a full, active, and wonderful life. The tools and resources available for you to care for your diabetes in the midst of a busy, productive and fulfilling life are better today than at any time in the modern history of diabetes care. -Dr. David Kendall, Eli Lilly, Indianapolis, IN

12 A1c necessary but not sufficient A seven-center, 21-day CGM study found that: People with type 1 diabetes were found to be in the optimal ADA glycemic zone only 28% of the time, on average spending over 2 hours/day in hypoglycemia Source: Dr. Bruce Bode, Diabetes Care, 2005 Glycemic Characteristics in Continuously Monitored Patients with Type 1 and Type 2 Diabetes

13 Why A1c does not tell the full story... An A1c of 7% = average of 154 mg/dl Range Example 1 < 70 mg/dl 8% mg/dl 63% > 180 mg/dl 29% Approximate A1c 7.0% Example 2 24% 18% 58% 7.0% Example 3-100% - 7.0% But time in range and thus quality of A1c can be drastically different! Source: the diatribe Foundation

14 Example 1 A1c of 7%

15 Example 2 A1c of 7%

16 Example 3 A1c of 7%

17 Medtronic MiniMed 530G (Enlite/Veo) FDA approved in late September 2013

18 Insulet s New OmniPod Launched in % smaller, 16% slimmer vs. old OmniPod New LifeScan Verio BGM handheld just submitted to FDA Working on combined pod/cgm integration

19 Telcare cellular-enabled blood glucose meter Wireless blood glucose monitor that automatically uploads results online Source: Close Concerns, Inc.

20 LifeScan OneTouch Verio Sync App and meter just launched in January. Wireless (Bluetooth) Source: Close Concerns, Inc.

21 Glooko MeterSync Cable/Web Platform Available for iphone and Android; compatible with 29 meters Working on Bluetooth version Source: Close Concerns, Inc.

22 Dexcom Share (remote monitoring) Under FDA review; potential 2014 launch Wireless Dexcom G4 Receiver + Docking Station CGM data sent to up to five followers smartphones Source: Close Concerns, Inc.

23 Animas Vibe with Dexcom G4 Platinum integration Under FDA review; potential launch in late 2014 Source: Close Concerns, Inc.

24 Tandem t:slim with Dexcom G4 Platinum integration Potential launch in late 2014/2015. Not yet submitted to FDA. Dual-chamber pump in development. Source: Close Concerns, Inc.

25 Medtronic MiniMed 640G (predictive suspend) European launch by October 31, 2014; no US timeline Predictive low glucose suspend much more effective than threshold suspend New pump platform and user interface New Enlite 2 CGM sensor Source: Close Concerns, Inc.

26 Outline About Us A snapshot of new and upcoming diabetes technology The bionic pancreas UVa s overnight closed-loop system The future of diabetes technology

27 A control algorithm running on an iphone

28 Two Tandem pumps + Dexcom G4 CGM

29 Dr. Ed Damiano (Boston University) Beacon Hill Study (amazing) 5 days of wear in 3 square-mile area Eat and exercise as wanted Average BG: 133 mg/dl, <1.5% <60 mg/dl Dr. Damiano s Timeline 2013: Beacon Hill, summer camp 2014: 12-day multi-center study 2014: Pre-adolescent summer camp ~2015/16: Pivotal study ~2017: Commercial launch Source: Close Concerns, Inc.

30 Amazing glucose control

31 I felt like a whole new Kelly

32 Outline About Us A snapshot of new and upcoming diabetes technology The artificial pancreas UVa s overnight closed-loop system The future of diabetes technology

33 UVa s Overnight Closed-Loop System Five nights in a research house. Dexcom CGM, smartphone controller, Roche pump

34 UVa s Overnight Closed-Loop System CLOSED-LOOP ON The control algorithm adjusts insulin delivery from 11pm-7am to target 120 mg/dl

35 Some of my learnings Overnight closed-loop worked WAY better than I can do on my own, and was much safer My insulin requirements vary A LOT from night to night Diabetes disrupts sleep OFTEN! Great nighttime glucose control even improved my blood sugars the next day starting every morning at 120 mg/dl is pretty powerful.

36 Where Are We Right Now with the Closed Loop? 70%+ time in target during day Excellent overnight control (often 90%+) Outpatient trials Strong algorithms, constant improvement Remote monitoring and portable systems

37 A successful system looms large, but challenges aren t for the faint of heart Optimal device development/ communication Faster insulin / Stable glucagon (chronic use) Reimbursement Regulatory (FDA/EU) requirements/commerci alization

38 Artificial Pancreas: Fully Closed Loop/Dual Hormone Upside Guaranteed <7% A1c Huge patient demand Better reimbursement? Entry barriers Disruptive technology (opportunity to take market share) Roadblocks Unpredictable regulatory environment Speed of insulin (meals) Other hormones/ dual-chamber pump Reliability/safety of CGM Portability Slide 38

39 Other Artificial Pancreas systems: Hybrid Closed Loop Predictive low glucose suspend Predictive CGM trend forecasting Treat-to-range control Automated basal control (bolus at mealtime) Impact (primarily on type 1) More focus on time in zone Improvement in time in zone and likely A1c A decline in hypoglycemia and severe hypoglycemia Pumps/CGMs increasingly becoming standard of care in newly diagnosed type 1s Achievable meaningful increased quality of life Slide 39

40 Outline About Us A snapshot of new and upcoming diabetes technology The artificial pancreas UVa s overnight closed-loop system The future of diabetes technology

41 I look forward to a future where devices are more integrated into my daily life hypoglycemia and hyperglycemia are much less frequent better management doesn t mean more burden an d hassle I don t have to think about diabetes as much!

42 I look forward to a future where Devices are more integrated into my daily life Hypoglycemia and hyperglycemia are less frequent Better management doesn t mean more burden/hassle I don t have to think about diabetes as much! Slide 42

43 Slide 43

44 Sign up for our free patient newsletter at Write to give views to academia/industry THANK YOU JDRF GREATER C&P! Slide 44

45 THANK Slide 45

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