ASHLEY AUSTIN HEATHER MICHAELA RYAN YOU CAN make managing diabetes easier.
Overview Insulet s vision and key milestones Why the OmniPod makes CSII adherence easier while improving control The OmniPod Insulin Management System: Key Features and Benefits Comprehensive Support and Easy Conversion Experience Clinical Studies Platform for Continuous Innovation Data Management Questions and Answers 2
Company vision Mission statement Insulet Corporation is dedicated to designing and developing products that provide superior treatment options and lifelong health benefits for people with diabetes. Clinical experience Trusted by tens of thousands of patients worldwide Leaders in innovation World s leading tubeless insulin pump Received numerous awards for innovation Clinical advancement Artificial Pancreas Project Next generation products 3
Company milestones 4
Global expansion New OmniPod positions Insulet for significant international growth LAUNCHED MARKETS 2013 FUTURE MARKETS USA NETHERLANDS AUSTRIA CHINA SAUDI ARABIA SWITZERLAND AUSTRALIA UK UAE QATAR ISRAEL ITALY NORWAY SWEDEN BELGIUM FRANCE INDIA POLAND SPAIN CANADA DENMARK GERMANY CZECH REPUBLIC RUSSIA 5
Makes adherence easier while improving control
OmniPod makes CSII adherence easier while improving glycemic control Truly continuous insulin delivery Helps safeguard against overuse of infusion sites 1 Key design features, such as tubing-free and automated insertion and priming More flexible site rotation 1 Significantly decreased A1C values 2 1. Insulin Pump Therapy: Best practices in choosing and using infusion devices. AADE whitepaper, 2011. 2. Kane M, Abelseth JM, Davis K, Hogan E, Hamilton RA. Clinical Experience with a Tubing-Free Insulin Pump System. Infusystems USA 2009;625-27. 7
Reasons for disconnecting a traditional pump Shower Sports Beach activities Water parks Hot tubs Sauna Whirlpool Heavy exercise Intimacy Downloading in the diabetes clinic Source: Insulin Pump Therapy: Best practices in choosing and using infusion devices: AADE whitepaper 2011; Table 7; p. 16. 8
Only OmniPod provides CSII that s truly continuous After reconnecting a tubed pump, blood glucose levels continued to rise 1 mg/dl for each minute insulin infusion was interrupted. With tubing-free OmniPod, there s no need to disconnect for bathing, showering, dressing, swimming or intimacy. Study completed with the OmniPod Insulin Management System, Model UST200; Zisser H. Diabetes Care. 2008;31:238-239. 9
Helps safeguard against overuse of infusion sites Patients using traditional pumps often overextend the use of their infusion set which leads to increases in BG. With the OmniPod, patients can t extend the use of the Pod beyond 72-80 hours. 1. Statistically significant increase (p<.05) from day 2 to 3. Source: Theti TK, Rao A, Kawji H, et al. Consequences of delayed pump infusion line change in patients with type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion. J Diabetes Complications. 2010;24:73-78. 10
OmniPod design features make CSII adherence easier Tubing-free design eliminates issues such as getting caught or tangled in tubing. Automated and consistent insertion alleviates potential for human error and this unique design helps ensure that the cannula is inserted at the correct angle and depth every time. Automated priming and tubing-free design ensures consistent priming with no concern with bubbles in tubing. 11
Simpler. Easier. 12
Most patients prefer OmniPod to a traditional pump 90% of patients prefer OmniPod automatic insertion over inserting with their current infusion set. 1 1. P<0.002 Zisser H. Diabetes Care. 2006;29:2175. Study completed with the OmniPod Insulin Management System, Model UST200. 13
OmniPod significantly decreased A1C values Design: patients (N=59) with type 1 diabetes (mean duration 14 years) switched from either a traditional pump (n=12) or MDI (n=47) to OmniPod. 25.5% of OmniPod patients achieved A1C<7%, compared to 5.7% of patients prior to initiation of the OmniPod. 2 1 1. P <.01 2. P<.001 MDI = Multiple daily injections Kane MP et al. Infusystems USA. 2009; 4:25-27. Study completed with the OmniPod Insulin Management System, Model UST200. 14
Safe. Small. Easy.
The OmniPod System platform Just two simple parts Fully integrated two-part design Built-in FreeStyle BG meter that automatically incorporates BG levels into suggested bolus calculations and history records Integrated infusion set, insulin reservoir, automated inserter, and batteries Automated processes Cannula insertion Priming Intuitive user interface Full text navigation Set-up wizard Easy to teach, easy to learn Waterproof Pod 16
The new OmniPod Insulin Management System
The next evolution in insulin pump therapy 18
The new Pod With the same 200 unit insulin capacity Compatible only with the new black PDM, UST400 19
The new Pod New design attaches the Pod to adhesive pad even more securely Integrated, automatic cannula insertion New pink slide insert clearly indicates when blue-tinted cannula is deployed Still waterproof, IPX8 (25 ft. for up to 60 minutes) 20
Easy by design Fully integrated design No assembly required Integrated insulin reservoir, infusion set, automated inserter, pumping mechanism and power supply Built-in BG meter and bolus calculator Automated processes Cannula insertion Priming Intuitive user interface Full text navigation Set-up wizard Reduced complexity 21
The new PDM Now uses correction and meal boluses to calculate insulin-on-board (IOB). Wireless communication range is even greater up to 5 feet New identification screen useful for determining PDM owner among multiple OmniPod users Bolus Calculator with expanded options Additional PDM options to customize alerts and reminders New sleek, black housing 22
Insulin on board PDM now uses correction and meal boluses to calculate insulin-on-board (IOB) IOB is conveniently displayed on the IOB status screen As a reminder, the IOB is determined by: Duration of insulin action Time since previous bolus The amount of the previous bolus 23
Three simple steps to start insulin delivery Fill a new Pod with insulin Apply Pod to infusion site Press Start to activate automated insertion 24
Pod placement options Pod can go anywhere a shot can be given, providing for more flexible site rotation. 25
New OmniPod System specifications Basal Programs and Segments 7 programs with up to 24 segments Programmable in 30-min increments Basal Increments and Maximum 0.05 U/h increments, up to 30 U/hr Temporary Basal Rates Percentage or U/hr adjustments Temporary Basal Duration 30 min to 12 h, in 30-min increments Bolus Increments 0.05, 0.1, 0.5, 1.0 units Integrated Reservoir Pod delivers up to 200 U U-100 rapid-acting insulin Pod Size and Weight 1.53 wide x 2.05 long x 0.57 high 25 gms without insulin PDM Size and Weight 2.5 x 4.5 x 1.0 4.4 oz (with batteries) PDM Memory 90 days of data (up to 5400 records) 26
Insulet's commitment to comprehensive support
Comprehensive training and support Our CDEs provide individual and group training to prospective patients, as well as current pumpers who want to advance their knowledge using the OmniPod. Easy-to-use interactive, online training at myomnipodtraining.com. Product Support representatives are product experts and offer assistance 24/7, 365 days per year. Product Support is available in 100 languages. Emergency product replacement. 28
Introducing myomnipodtraining.com 29
New interactive training programs Designed to meet the educational needs of all new and existing patients and HCPs Module 1 (New Patients) Getting Ready for OmniPod System Training Includes certificate of completion Accessible via myomnipodtraining.com Module 4 (New Patients) In-person Training Includes Instructor Guide for HCPs Accessible via myomnipodtraining.com and CPT Portal 30
New interactive training programs Designed to meet the educational needs of all new and existing patients and HCPs Module 2 (Converting Patients) Getting Ready to Upgrade Includes Resources and Help pages Accessible via myomnipodtraining.com and e-mail outreach based on reorder date Module 3 (All Patients and HCPs) Interactive Guide Accessible via myomnipodtraining.com 31
New interactive training programs Designed to meet the educational needs of all new and existing patients and HCPs Module 5 (HCPs) Certification program for CDEs Includes certification exam Printable certificate upon successful exam completion Accessible via CPT Portal 32
Insurance coverage and benefits investigation The OmniPod is covered by a broad range of national and regional health insurance plans. We provide hassle-free benefits investigation, working closely with your patients to interpret their benefits and complete the billing. Auto-Ship Program automatically mails a three-month supply of Pods each quarter. We offer a limited 45-day money-back guarantee subject to certain terms and conditions. 33
Easy conversion experience
Transitioning patients to the new OmniPod is as easy as 1, 2, 3 Patient will be notified by Insulet when it s time to convert. Patient is encouraged to complete an easy online conversion training available at myomnipodtraining.com. Patient automatically receives the new OmniPod System with their next reorder shipment. 35
Effective pump therapy
Pump therapy vs. MDI: Significant overall improvement The following were demonstrated in the 2010 Cochrane meta-analysis: A -0.3% (95% CI -0.4 to -0.1) improvement in A1C compared to multiple daily injections * Reduction in the dawn phenomenon Daily reduction in the use of insulin (-7 units) Data from 15 of the 23 trials suggests insulin pumps may be better than MDI for reducing the incidence of severe hypoglycemic events. ** Most studies reporting quality-of-life (QOL) measures demonstrated patients are more satisfied with an insulin pump vs. MDI. *** 1. Misso et al. Cochrane Database Syst Rev. 2010:CD005103. * Meta-analysis of 23 randomized controlled trials in over 976 patients with type 1 diabetes. ** No difference in non-severe hypoglycemia *** 15 trials reported validated QOL measures; MDI = multiple daily injections 37
Traditional pump positioning may lead to siphon effect Clothing choice and necessity means patients wear traditional pumps positioned in many different ways. A pump might be positioned in a bra, top or below the waistband. Positioning above or below the insertion site leads to a siphon effect associated with the tube-dependent delivery, which may affect accurate insulin delivery. Zisser HC. J Diabetes Sci Technol. 2010;4:98-103. Study completed with the OmniPod Insulin Management System, Model UST200. 38
OmniPod avoids the siphon effect associated with traditional pumps Pronounced differences in accuracy from 74.5% to 123.3% Variations in positioning a traditional pump affects accurate insulin delivery. This effect may be more pronounced at lower doses, e.g., in patients requiring a low basal rate. Study completed with the OmniPod Insulin Management System, Model UST200. Zisser HC. J Diabetes Sci Technol. 2010;4:98-103. 39
A platform for continuous innovation
OmniPod selected for the Artificial Pancreas Project Since 2006, OmniPod has been used in multiple closed-loop trials in 11 global sites. Zisser H. Diabetes Ther. 2010;1 (1): 10-24. 41
OmniPod selected for global, closed-loop trial OmniPod is the only pump selected and is paired with the DexCom TM SEVEN PLUS and sophisticated, computer software. 50 patients at 7 inpatient clinical centers. Sponsored by the JDRF Artificial Pancreas Project Consortium, NCT01271023. The University of Virginia School of Medicine has launched the first U.S. outpatient trial of a UVA-developed artificial pancreas that could make it easier for type 1 diabetes patients to manage their condition. JDRF = Juvenile Diabetes Research Foundation. DexCom SEVEN PLUS is a registered trademark of Dexcom Inc. Data on file. 42
Research shows greatest patient and caregiver enthusiasm 96% would recommend OmniPod to a friend. 1 1. Data on file: OmniPod customers surveyed (1,531 responses) Oct 2012. 2. Independent research conducted with the dq&a panel (N= 1039) of patients, parents, and caregivers Q3 2012 comparing OmniPod to other current pumps. All pumps include Medtronic 522, 722, Revel; Animas IR 2020, Ping; OmniPod; Accu-Check Spirit. Net Promoter Score (NPS) represents those who strongly recommend their pump minus those who advise against. 43
Continuous Glucose Management with OmniPod
CGM desired? The OmniPod + CGM provides a tubeless solution OmniPod and a CGM combine to maintain a tubeless and wireless system. Choose any CGM that s right for you and your patients. The OmniPod s built-in FreeStyle blood glucose meter makes calibrating the CGM more convenient no additional meter needed. Flexible positioning of the OmniPod makes it easier to rotate the sensor location. CGM = continuous glucose monitor. FreeStyle is a registered trademark of Abbott Laboratories. 45
Data management
Download with the OmniPod Extension HCPs and patients can download insulin, BG, and carb data from PDM Customizable reports and trending graph functionality Unique device-to-user association HCPs and patients can share data via web synchronization Works with CoPilot software available from Abbott at www.abbottdiabetescare.com New OmniPod Extension software for UST400 is available on MyOmniPod.com USB cable provided by Insulet OmniPod Extension software and USB cable available through Insulet. CoPilot is a registered trademark of Abbott Laboratories. 47
Get your patients started on OmniPod today Presenter s Name Insulet Corporation jsmith@insulet.com tel: 781.000.0000 15124-AW Rev 2 02/13 48
Appendix
CoPilot Health Management System logbook report Logbook table provides glucose, carbohydrate, and insulin values for each time period over a specified date range CoPilot is a registered trademark of Abbott Laboratories. 50
OmniPod articles and research Labenthal, Y, Patient Perceptions of Using the OmniPod System compared with Conventional Insulin Pumps in Young Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics, May 2012. Zisser, H, Novel Methodology to Determine the Accuracy of the OmniPod Insulin Pump: A Ken Component of the Artificial Pancreas System. Journal of Diabetes Science and Technology, November 2011. Lane, W, A Prospective Trial of U500 Insulin Delivered by OmniPod in Patients with Type 2 Diabetes Mellitus and Severe Insulin Resistance. Endocrine Practice, September 2010. Zisser, H, The OmniPod Insulin Management System: The Latest Innovation in Insulin Pump Therapy. Diabetes Therapy, August 2010. Sirotinin, S, Computer-Aided Learning in Insulin Pump Training. Journal of Diabetes Science and Technology, July 2010. Zisser, H, Siphon Effects on Subcutaneous Insulin Infusion Pump Delivery Performance. Journal of Diabetes Science and Technology, January 2010. Dassau, E, In Silico Evaluation Platform for Artificial Pancreatic b-cell Development- A Dynamic Simulator for Closed-Loop Control with Hardware-in-the-Loop. Diabetes Technology & Therapeutics, November 2009. 12958 R3 09/08 51
OmniPod articles and research Bruttomesso, D, Closed-Loop Artificial Pancreas Using Subcutaneous Glucose Sensing and Insulin Delivery and a Model of Predictive Control Algorithm: Preliminary Studies in Padova and Montpelier. Journal of Diabetes Science and Technology, September 2009. Zisser, H, Quantifying the Impact of a Short-Interval Interruption of Insulin Pump Infusion Sets on a Glycemic Excursion. Diabetes Care, February 2008. Kane, M, Clinical Experience with a Tubing-Free Insulin Pump System. Infusion Systems USA, 2009. Clarke, W, Closed-Loop Artificial Pancreas Using Subcutaneous Glucose Sensing and Insulin Delivery and a Model Predictive Control Algorithm: The Virginia Experience. Journal of Diabetes Science and Technology, 2009. Kovatchev, B, Brenton, M, Man, C, Cobelli, C, In Silico Preclinical Trials: A Proof of Concept in Closed-Loop Control of Type 1 Diabetes. Journal of Diabetes Science and Technology, 2009. DiIanni, S, Garibott, J, An Innovative Application of Shape Memory Alloy (SMA) Technology Yields a Novel therapeutic Approach to Diabetes Management. Technical Article, 2006. Zisser, H, Jovanovic, L, OmniPod Insulin Management System: Patient Perceptions, Preference, and Glycemic Control. Diabetes Care, September 2006. 52
Simple. Small. Easy. Easiest* pump for patients to train and learn Nothing to disconnect before changing or exercise Waterproof Pod means no worries when getting wet Integrated, hands-free, virtually pain-free cannula insertion Goes anywhere an ordinary injection can be given Unique PDM has integrated FreeStyle blood glucose meter FreeStyle is a registered trademark of Abbott Laboratories. *Study completed with the OmniPod Insulin Management System, Model UST200. 53