Animas Vibe System World-class insulin pumping meets world-class CGM*

Transcription

1 Animas Vibe System World-class insulin pumping meets world-class CGM* Fully integrated with Dexcom G4 PLATINUM CGM* *Continuous glucose monitoring.

2 My Animas pump has really put me in the driver s seat and made controlling my diabetes that much easier. Iain Animas pumper since 2008 Animas Vibe System Best-in-class insulin pump accuracy The first insulin pump with Dexcom G4 PLATINUM CGM

3 Discover performance that s simply advanced In-pump food database Precise bolus calculator with Jump-to-Value bolus populator First CGM-enabled insulin pump with a high-contrast color screen Color-coded trend arrows and lines show the direction and rate of glucose change, and glucose levels Continuous glucose data shown in 1-, 3-, 6-, 12-, and 24-hour increments Small, water-resistant CGM transmitter* CGM screen shortcut button CGM sensor approved for up to 7 days of wear Animas patented drive technology optimizes pump performance Proven waterproof at 12 feet for up to 24 hours * * The Dexcom G4 PLATINUM Sensor and Transmitter are water-resistant up to 8 feet for 24 hours. CGM readings may not be transmitted from the CGM to the pump while in water. 3

4 Animas Vibe System Performance pumping fueled by Animas patented drive technology Fine-tuning The pump system reviews basal dosing every 3 minutes and adjusts insulin delivery as needed to minimize variability. Speed The high-speed pump motor helps to accelerate bolus delivery. Precise bolus calculator The patented bolus calculator is designed to bring blood glucose values to the target midpoint. Accuracy The pump s high gear ratio helps to drive more accurate basal delivery. 4

5 Superior dosing accuracy 1-3 Animas Vibe pump demonstrates significantly better accuracy per basal delivery vs Medtronic MiniMed 530G,* Insulet OmniPod and Tandem t:slim Dose-to-dose variability comparison of typical pump performance % Error in Dose Volume Animas Vibe vs Medtronic MiniMed 530G 1 * Animas Vibe Medtronic MiniMed 530G Test Duration (hr) 86% Animas Vibe 73% Medtronic MiniMed 530G* P=.0009 In 3 separate studies comparing dose-to-dose accuracy, all pumps were programmed to deliver a basal rate of U/hr over 20 hours. Animas Vibe pump and Medtronic MiniMed 530G* delivered U at 3-minute intervals; Insulet OmniPod delivered U at 6-minute intervals; and Tandem t:slim delivered approximately U at 5-minute intervals. Thirty data sets, per pump, were assessed. In total, doses, doses, 5977 doses, and 7200 doses were delivered for Animas Vibe pump, Medtronic MiniMed 530G,* Insulet OmniPod, and Tandem t:slim pumps, respectively. Results (%) represent cumulative doses within ±10% accuracy threshold for all 30 data sets Animas Vibe vs Insulet OmniPod 1 Animas Vibe vs Tandem t:slim 2 % Error in Dose Volume Animas Vibe Insulet OmniPod % Error in Dose Volume Animas Vibe Tandem t:slim Test Duration (hr) Test Duration (hr) 86% Animas Vibe 23% Insulet OmniPod P< % Animas Vibe 51% Tandem t:slim P<.0001 The clinical advantage of basal accuracy has not been established. * A combination of 2 Medtronic MiniMed Paradigm Revel TM and 4 Veo TM pumps were assessed. The Paradigm Veo TM pump is available for sale in select markets outside the US. The Medtronic MiniMed 530G pump is unchanged from the Paradigm Revel TM pump, with the exception of the added Threshold Suspension tool and some minor software differences. Testing was conducted with OneTouch Ping, which has the identical insulin delivery mechanism functionality as Animas Vibe. For each manufacturer, typical pump performance is the data set with the median standard deviation in percentage dose error. 5

6 Superior bolus delivery speed 2,3 Animas Vibe pump was significantly faster than Medtronic MiniMed 530G and Insulet OmniPod 3* 5 U 15x faster than Medtronic MiniMed 530G 15x faster than Insulet OmniPod 10 U 11x faster than Medtronic MiniMed 530G 15x faster than Insulet OmniPod A short bolus delivery duration may result in faster insulin absorption. Faster insulin absorption may provide better control of meal-related glucose excursions. 4\ 25 U 4.5x faster than Medtronic MiniMed 530G 15x faster than Insulet OmniPod Time (minutes) (P<.0001) Animas Vibe Medtronic MiniMed 530G Insulet OmniPod To compare the bolus delivery speed of 3 insulin pump models, a study measured the time to reach the lower threshold within 95% of the required bolus volume. Pumps were manually programmed to deliver distinct bolus amounts at 5 U, 10 U, and 25 U. Four Animas Vibe pumps, 2 Medtronic MiniMed Paradigm Revel and 1 Veo, and 7 Insulet OmniPod produced at least 7 data sets each. Animas Vibe pump was also significantly faster than Tandem t:slim 2 5 U 7.5x faster than Tandem t:slim 10 U 7.4x faster than Tandem t:slim 25 U 7.6x faster than Tandem t:slim Time (minutes) (P<.0001) Animas Vibe pump Tandem t:slim To compare the bolus delivery speed of 2 insulin pump models, a study measured the time to reach the lower threshold within 95% of the required bolus volume. Pumps were manually programmed to deliver distinct bolus amounts at 5 U, 10 U, and 25 U. 5 Animas Vibe pumps and 5 Tandem t:slim pumps produced 10 data sets each (2 runs each on 5 different pumps per bolus dose). * A combination of 2 Medtronic MiniMed Paradigm Revel TM and 4 Veo pumps were assessed. The Paradigm Veo TM pump is available for sale in select markets outside the US. The Medtronic MiniMed 530G pump is unchanged from the Paradigm Revel TM pump, with the exception of the added Threshold Suspension tool and some minor software differences. Testing was conducted with OneTouch Ping, which has the identical insulin delivery mechanism functionality as Animas Vibe. Twenty type 1 diabetic subjects were studied on 2 occasions, separated by at least 7 days, using the euglycemic clamp procedure. Following an overnight fast, subjects were given, in random order, a subcutaneous insulin bolus either over 30 seconds (short bolus) or over 10 minutes (long bolus). \ Testing was conducted with OneTouch Ping, which has the identical insulin delivery mechanism functionality as Animas Vibe. 6

7 Fine-tuned basal dosing Animas Vibe pump is the only CGM-integrated pump to deliver a low, U/hr increment across all basal rates (0.025 U/hr to 25 U/hr). Precise bolus calculator 5 Differences in bolus calculator technologies may impact recommended amounts of insulin for both mealtime bolusing and correction doses 5 The Animas Vibe System s bolus calculator is designed to bring blood glucose levels closer to the target value by correcting to the midpoint of the programmed blood glucose target range. The Medtronic MiniMed 530G bolus calculator corrects to the upper or lower limit of the range.* Correcting only to the limits of the target range impacts the amount of insulin recommended and whether or not a correction is recommended. 5 Animas Vibe System bolus calculator algorithm corrects to the midpoint of the target blood glucose range HYPERGLYCEMIA Medtronic MiniMed 530G corrects to upper limit of target range 4 * BLOOD GLUCOSE (mg/dl) UPPER LIMIT OF TARGET TARGET MIDPOINT LOWER LIMIT OF TARGET Animas Vibe corrects to midpoint of target range Animas Vibe corrects to midpoint of target range HYPOGLYCEMIA Medtronic MiniMed 530G corrects to lower limit of target range* * The bolus calculator in the Medtronic MiniMed 530G pump is unchanged from the bolus calculator in the Paradigm Revel pump. Medtronic Bolus Wizard feature information from Medtronic MiniMed Paradigm Revel and Medtronic MiniMed 530G User Guides. 7

8 Animas Vibe System CGM* excellence defined by superior accuracy and precision Dexcom G4 PLATINUM CGM* delivers on clinical performance and simplicity Excellent overall accuracy The sensor s geometry, membrane technology, and algorithm set it apart 13% overall mean absolute relative difference (MARD) signifies exceptional performance and accuracy 6 Longest sensor wear Animas Vibe System is the first CGM-enabled pump with a sensor approved for up to 7 days of wear Reveals glucose trends at a glance Color-coded trend lines Blue, red, or green trend lines indicate that glucose levels are low, high, or within the target range relative to the low and high alerts set in the pump Smallest introducer needle The Dexcom G4 PLATINUM introducer needle is smaller than the Medtronic Enlite introducer needle Patients can view their insulin on board right on the CGM data screen Dexcom G4 PLATINUM introducer needle Medtronic Enlite introducer needle Tiny, flexible sensor wire * Continuous glucose monitoring. From a study of 60 patients using the Dexcom G4 Sensor with a hand-held receiver first calibrated at 1 hour and then approximately every 12 hours following. Similar overall performance has been seen with 1-hour and 2-hour initial calibration. The transmitter and receiver used in the Dexcom G4 Sensor clinical trial were different than those used with the Animas Vibe System, but the Dexcom G4 Transmitter and Animas Vibe pump function similarly to the transmitter and receiver used in the trial but with a 2-hour initial calibration. Based on manufacturers user guides: Data on file; Medtronic MiniMed Paradigm REAL-Time Veo, Measured as the cross-sectional area of the introducer needle. 8

9 CGM* accuracy and precision Demonstrated clinical performance of Dexcom G4 PLATINUM CGM 6* ACCURACY 6 Mean ARD % (MARD) 40 mg/dl 400 mg/dl HYPO ACCURACY 6 Within 20 mg/dl of YSI 40 mg/dl 80 mg/dl LONGEVITY 6 Sensor life up to indicated use 13 % Exceptional performance and accuracy for reliable results you can count on Outstanding accuracy in the hypoglycemia zone where it 83 % really matters 94 % Longest-wear 7-day sensor with 94% lasting up to indicated use for added value and user convenience Greater CGM* accuracy and precision demonstrated by Dexcom G4 PLATINUM vs Medtronic Enlite in a comparative study 7 Venous plasma glucose measurements taken at 15-minute intervals were paired with corresponding CGM measurements for 48 hours (n=4,294). Dexcom G4 10.8% PLATINUM CGM* sensor accuracy and precision were measured using mean absolute relative difference (MARD). 17.9% Medtronic Enlite MARD measures the average disparity between a CGM sensor and a reference value. Lower MARD indicates greater accuracy. * Continuous glucose monitoring. Dexcom G4 PLATINUM User Guide, Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. Data presented at the 73rd ADA Scientific Sessions; June 21-25, 2013; Chicago, IL. 9

10 B:9.5 T:9 Software solutions An extra dimension of diabetes control View customized patient reports and streamline Animas pump patient management Web-based system transmits and stores blood glucose, insulin pump, and Dexcom G4 PLATINUM Sensor data. The data is automatically organized into charts and graphs that you and your patients can view. T:12 A range of standard clinical reports A 360 view of patient behavior More informative appointments To Contact Us regarding this Job, Scan this QR Code. For best results, please have the Job Number and/or Project Manager name available. Johnson & Johnson JJYANAM52380 Animas Adult Detail Aid Inside Pages 100% 9.5 x x x 11.5 J. Hutchinson J. Elsesser J. Elsesser : Filexchange-ClientJobs:Volumes:Filexchange-ClientJobs:Animas:Current:Jobs:32611_Animas_AdultDetailAid:32611_Animas_AdultDetailAid_InsidePages_p14.indd 32611_Animas_AdultDetailAid_InsidePages_p14.indd Indesign CS6 8.0 Beata Molska :29 PM :31 PM :31 PM :30 PM 100% CMYK day by day overview[1].jpg (444 ppi) Helvetica Rounded LT Std (OpenType), Avenir LT Std (OpenType) CMYK B:12.5 Efficient data downloading and navigation ease

11 Animas A range of performance pump options for your patients Animas Vibe System World-class Animas pump technology integrated with Dexcom CGM technology. OneTouch Ping Combines world-class Animas pump technology with the convenience of a wireless meter-remote. 11

12 B:26.25 T:25.75 NO INK FS:0.625 F1 S:25.25 Animas Animas Count on 24/7 support A range of performance pump options for your patients > TEACHING Live and online classes for patients World-class Animas pump technology integrated with Dexcom CGM technology. > AVAILABLE AROUND THE CLOCK 24/7 support hotline with healthcare professionals available FS:11.75 Learn more at animas.com Animas Corporation A Johnson & Johnson Company 965 Chesterbrook Boulevard Wayne, PA Phone: YES-PUMP ( ) comments@animas.com OneTouch Ping WARNINGS Connecting to the pump before receiving the necessary training could result in serious injury or death. Younger children may inadvertently press the pump buttons and deliver insulin, which can lead to hypoglycemic events. Caregivers are responsible for helping to ensure safe and effective delivery of insulin to people in their care, including using the safety features on the Animas Vibe System to help prevent injury. CGM glucose readings are not to be used to make treatment decisions. The sensor and transmitter do not replace a blood glucose meter. The sensor and transmitter are not to be used during pregnancy or while on dialysis. Sensor placement is only approved for sites under the skin of the belly (abdomen) in adults and the belly or upper buttocks for ages 2 to 17 (pediatrics). Patients should seek professional medical help if a sensor breaks and no portion of it is visible above the skin, or if there is infection or inflammation. Any broken sensors or adverse events should be reported to Customer Service. Contact Customer Service at or visit for detailed indications for use and safety information. Combines world-class Animas pump technology with the convenience of a wireless meter-remote. Animas has earned The Joint Commission s Gold Seal of Approval. Animas has received ISO 13485:2003 (International Organization for Standardization) certification. By meeting these most rigorous standards, Animas is committed to superior quality and safety for its customers. Fully integrated with Dexcom G4 PLATINUM CGM* REFERENCES: 1. Jahn LG, Capurro JJ, Levy BL. Comparative dose accuracy of durable and patch insulin infusion pumps. J Diabetes Sci Technol. 2013;7(4): Capurro JJ, Levy BL, Venugopalan R. Precision, Accuracy, and Delivery Speed of Durable and Patch Insulin Infusion Pumps. Abstract and poster presented at: 9th International Conference on Advanced Technologies and Treatments for Diabetes; February 18-21, 2015; Paris, France. 3. Capurro J, Jahn L. Quantitative analysis of bolus delivery speed amongst insulin infusion pumps. Abstract and poster presented at: 4th International Conference on Advanced Technologies and Treatments for Diabetes; February 16-19, 2011; London, UK. 4. Regittnig W, Urschitz M, Lehki B, et al. Absorption kinetics of insulin following subcutaneous bolus administration with different bolus durations. Paper presented at: 73rd American Diabetes Association Scientific Sessions; June 21-25, 2013; Chicago, IL. 5. Zisser H, Wagner R, Pleus S, et al. Clinical performance of three bolus calculators in subjects with type 1 diabetes mellitus: a head-to-head-to-head comparison. Diabetes Technol Ther. 2010;12(12): Dexcom G4 PLATINUM User Guide, Damiano ER, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. Data presented at the 73rd ADA Scientific Sessions; June 21-25, 2013; Chicago, IL. All product names and trademarks are the property of their respective owners Animas Corporation 2016/03 Rx Only ANM D. *Continuous glucose monitoring. F1 FS: NO INK FS:7.375 FS:8.75 F7.75 FS:8.625 F To Contact Us regarding this Job, Scan this QR Code. For best results, please have the Job Number and/or Project Manager name available. Johnson & Johnson JJYANAM52380 Animas Adult Detail Aid Cover Die Line F9 J. Hutchinson 100% x x x 13.5 J. Elsesser J. Elsesser : Filexchange-ClientJobs:Volumes:Filexchange-ClientJobs:Animas:Current:Jobs:32611_Animas_AdultDetailAid:32611_Animas_AdultDetailAid_CoverDieLine_p9.indd 32611_Animas_AdultDetailAid_CoverDieLine_p9.indd Indesign CS6 8.0 Beata Molska :43 PM :44 PM :44 PM :19 PM 60% CMYK CMYK, PMS 390 C, Dieline Vibe_AngSyst_BlkBkgrd_24HrTrendScrn_4C_HR_LrgExtended_3_r2.psd (376 Avenir LT Std (OpenType), Helvetica ppi, 373 ppi), Animas_EMEA_NoOrtho_logo_KO.ai, P47051_Vibe_Colors_BlkB- Rounded LT Std (OpenType), Univers LT kgrd_family_4c_hr_r3.psd (456 ppi), 07_Goldseal_4C.ai, Vibe_AngSyst_24Hr- Std (OpenType), Myriad Pro (OpenType) TrendScrn_4C_HR.psd (353 ppi), PingCombo_Slvr_Backlit-2012_4C_HR_r2.psd (457 ppi) B:14.5 CONTRAINDICATIONS Insulin pump therapy is not recommended for people unwilling or unable to test their blood glucose four to six times per day, unwilling or unable to see their healthcare professional regularly, or whose vision or hearing does not allow recognition of pump alerts, warnings, and alarms. The Animas Vibe Insulin Pump must be removed before MRI or CT scan, and the Dexcom G4 PLATINUM Sensor and Transmitter must be removed before MRI, CT scan, or diathermy treatment. Taking acetaminophen-containing medications while wearing the sensor may falsely raise sensor glucose readings. T:14 IMPORTANT SAFETY INFORMATION The Animas Vibe Insulin Pump and CGM System is intended for the delivery of insulin and for continuous glucose monitoring (CGM) for the management of insulin-requiring diabetes. The Animas Vibe System s CGM, which includes the Dexcom G4 PLATINUM Sensor and Transmitter, is indicated for detecting trends and tracking patterns in persons age 2 and older. The system is intended for single patient use and requires a prescription. S:13.5 F12 Prescribe performance > TRAINING Programs and technology updates for you Animas Vibe System Animas Vibe System World-class insulin pumping meets world-class CGM*