This presentation was delivered at the 2017 JDRF TypeOneNation Summit in Tulsa, OK on 1/28/2017. It is a summary of insulin pumps, CGMs, data display and management software, and other aspects of technology related to type 1 diabetes.

1. 2017 TYPE ONE NATION SUMMIT
TECHNOLOGY UPDATE
CLAYTON MCCOOK, DVM
T1D PARENT

2. INTRODUCTION
• Personal Information/Background
• Our family/our Lily
• Personal introduction to diabetes technology
• Disclaimer/Financial Conflicts of Interest

3. SOURCES/ACKNOWLEDGEMENT
• Company websites
• diaTribe (www.diatribe.org)
• DiabetesMine (www.healthline.com/diabetesmine)
• Diabettech (www.diabettech.com)
• Nightscout (www.nightscout.info, www.nightscoutfoundation.org)
• OpenAPS (www.openAPS.org, www.diyps.org)
• Gottabemobile.com

4. OVERVIEW
• Pump technology
• CGM technology
• Smart meters and pens
• Data management platforms
• Diabetes management apps
• Future “AP” products
• DIY technology
• Nightscout
• Smart watches
• DIY “loop” systems

5. PUMP TECHNOLOGY
•Animas
•Insulet
•Medtronic
•Tandem

6. ANIMAS VIBE
• Integrated with Dexcom G4 CGM
• Approved for children as young as 2
• Basal rate increments as low as 0.025 U/h (range: 0.025-25 U/h)
• Bolus rate increments as low as 0.05 U (range: 0.05-35 U)
• Completely waterproof/submergible up to 12 feet for 24 hours

7. ANIMAS ONETOUCH PING
• Approved for patients 18 and older
• Basal rate range 0.025-25 U/h
• Completely waterproof/submergible up to 12 feet for 24 hrs.
• Bolus calculator installed
• Calorie King database of over 500 foods
• Remote bolus feature via One Touch meter

8. ANIMAS ONETOUCH VIBE PLUS
• FDA approval 12/20/2016
• First insulin pump integrated with Dexcom G5
• Approved for patients age 2 and older
• Approved by Health Canada on same day
• Similar specs as OneTouch Vibe

9. ANIMAS FUTURE PLANNED TECH
• Hybrid “closed-loop” technology
• Built-in hyper- and hypoglycemia minimizer
• Animas pump/Dexcom CGM
• Pivotal trial in 2016, hope to launch in 2017
• Note
• 1/23/17 earnings call
• “exploring everything from selling these divisions off, to shutting them down
completely, to creating ‘operating partnerships’ or strategic alliances to keep
them afloat.”
• source: www.healthline.com/diabetesmine/jnj-diabetes-evaluating-business

10. INSULET
• Omnipod system: pod + PDM
• Only tubeless pump on market
• Waterproof/submergable
• Hands-free insertion (cannula)
• Approved for all ages
• Basal range 0.05-30 U/h
• Bolus range 0.05-30 U (increments of 0.05/0.1/0.5/1 U)

11. INSULET FUTURE PLANS
• Next-generation mobile pod
• Bluetooth-enabled PDM and mobile app
• Able to see IOB, bolus, and Dexcom G5 data on app
• Expected to debut in 2017 at ADA Scientific Sessions
• Omnipod Horizon Automated Glucose Control System
• Algorithm integrated into pod
• Hybrid closed loop
• Investigational study on algorithm in adults completed
• Expected launch in 2019

12. MEDTRONIC MINIMED PARADIGM
• Stand-alone pump (not compatible with CGM)
• 2 models available:
• 523: 180 U reservoir
• 723: 300 U reservoir
• Remote control capabilities/linking meter
• Basal rate increments as low as 0.025 U/h (range: 0.025-35 U/h)
• Bolus rate increments as low as 0.025 U (range: 0.025-25 U)
• Bolus Wizard to help avoid “stacking”
• Not waterproof (must disconnect to swim/bathe)

13. MEDTRONIC MINIMED 530G
• Compatible with Enlite Sensor (built-in CGM)
• 2 models available: 180 U reservoir/300 U reservoir
• Basal rate increments as low as 0.025 U/h (range: 0.025-35 U/h)
• Bolus rate increments as low as 0.025 U (range: 0.025-25 U)
• Not waterproof (must disconnect to swim/bathe)
• Approved for ages 16 and up
• Bolus Wizard to help avoid “stacking”
• Linking meter
• Threshold Suspend capability with predictive alerts
• Stops insulin delivery for up to 2 hrs. if CGM reads below set value
• Notifies you before sensor reads high or low

14. MEDTRONIC MINIMED 630G
• Compatible with Enlite Sensor (built-in CGM)
• Color screen with automatic light adjustment
• Basal rate increments as low as 0.025 U/h (range: 0.025-35 U/h)
• Bolus rate increments as low as 0.025 U (range: 0.025-25 U)
• Waterproof up to 12 feet for up to 24 hrs.
• Approved for ages 16 and up
• SmartGuard technology with predictive alerts
• Stops insulin delivery for up to 2 hrs. if CGM reads below set value
• Notifies you before sensor reads high or low

15. MEDTRONIC MINIMED 670G
• FDA approval granted Sept. 2016, will ship in 2017
• Approved for ages 14 and up (pediatric study underway)
• Compatible with Guardian Sensor 3
• Utilizes SmartGuard HCL (hybrid closed loop) technology
• Performs automatic adjustments to basal rates
• User must still bolus for meals/blood sugar correction
• Similar specifications/appearance as 630g

16. TANDEM T-SLIM G4
• Integrated with Dexcom G4 CGM
• Approved for ages 6 and older
• Micro-Delivery® technology
• Basal rate increments as low as 0.001 U/h (range: 0.001-35 U/h)
• Bolus as low as 0.05 U minimum bolus, 25 U maximum bolus
• Smallest CGM-enabled pump on market
• Full color touchscreen display, watertight
• 300 U capacity

17. TANDEM T:SLIM X2
• Smallest insulin pump on market
• Approved for ages 6 and older
• Micro-Delivery® technology
• Basal rate increments as low as 0.001 U/h (range: 0.001-35
U/h)
• Bolus as low as 0.05 U minimum bolus, 25 U maximum bolus
• Full color touchscreen display, watertight
• Bluetooth-enabled (remote software updating capability)
• 300 U capacity

18. TANDEM T:FLEX
• Designed for people w/insulin needs >80 U/day (480 U capacity)
• Approved for ages 12 and older
• Micro-Delivery® technology
• Basal rate increments as low as 0.05 U/h (range: 0.05-35 U/h)
• Bolus as low as 0.05 U minimum bolus, 60 U maximum bolus
• Full color touchscreen display, watertight

19. TANDEM FUTURE PLANS
• Dexcom G5-enabled t:slim X2: mid-2017
• Automated Insulin Delivery system: end of 2017
• 1st generation: Predictive Low Glucose Suspend
• Feasibility trial finished in August 2016, pivotal trial early 2017
• Second-generation Tandem system: 2018
• Utilization of Dexcom G6 sensor & TypeZero Technologies algorithm
• University of Virginia (more later)

20. CGM TECHNOLOGY
• Dexcom
• Medtronic
• Abbott Freestyle Libre

21. DEXCOM
• Dexcom G4 Platinum with Share
• Requires use of receiver
• Receiver paired with iPhone  data to cloud
• Range: 40-60 feet
• Approved for ages 2 and older
• Labeled for 7 day wear, average error 9% †
• Dexcom G5
• Receiver not required
• BT-enabled transmitter (larger)
• Direct pairing with iPhone  data to cloud
• Range: 15-20 feet
• Approved for ages 2 and older
• Labeled for 7 day wear, avg. error 9% †
†Source: https://diatribe.org/fda-approval-medtronic-minimed-670g-hybrid-closed-loop-system

22. DEXCOM SHARE FOLLOWERS
• Use of Follow app (iOS or Android)
• PWD can have up to 5 “followers”
• Can follow up to 5 PWD
• G4 with Share or G5
• Can customize alerts
• Can get readings on Apple Watch, Pebble, Android Wear

23. DEXCOM FDA FINGERSTICK REPLACEMENT
• Granted on 12/20/2016
• Allows users to replace finger stick for dosing decisions
• First CGMS allowed to be used to make decisions
• Approval for patients age 2 and older
• Still requires twice a day calibration
• Potential ramification: CMS (Medicare)

24. • Dexcom G5x: 50% smaller transmitter than G5
• Dexcom G6 sensor
• 10-14 day wear, single calibration per day
• Pivotal trial started, hope to launch in 2018
• Next-generation receiver: touchscreen display
• Next-generation inserter: push-button
• Google Tech: collaboration with Verily for small sensor: 2018-
2020
DEXCOM FUTURE PLANS

25. MEDTRONIC CGM
• Enlite sensor
• Compatible with 530g and 630g pumps
• Medtronic claims “manufacturing updates” to improve performance
• One-touch inserter now available
• Labeled for 6 day wear, average error 14% †
• Guardian Sensor 3
• FDA approval 2016, launch later this year
• Compatible with 670g pump
• Labeled for 7 day wear, average error 10.6% †
†Source: https://diatribe.org/fda-approval-medtronic-minimed-670g-hybrid-closed-loop-system

26. MINIMED CONNECT
• Uploader communicates w/pump via RF
• Uploader uses BLE to send data to mobile app
• Data can be remotely monitored and downloaded
• iOS or Android
• Displays CGM and pump data
• CGM: current sensor reading (3,6,12, 24-hr. graphs available)
• Pump: active insulin, insulin in reservoir, pump battery level

27. FREESTYLE LIBRE CGM
• Libre Pro approved in U.S.
• Small sensor worn on arm (about quarter size)
• 2 week wear, no calibration
• Scanned for data at office visit(s)
• Unlike Freesyle Libre (Europe), no reader device

28. SMART METERS
• One Drop Chrome
• FDA approval 12/6/16
• Subscription based platform
• Meter sends data to cloud via Android or iOS
• Dario All-In-One BGM system
• Integrated meter, strips, lancets, mobile app, and web portal
• Turns smartphone into BG meter (Android or iOS)
• Subscription based platform
• Other “smart” meters (BLE): Roche’s Accu-Chek Connect, LifeScan’s
OneTouch VerioSync, Livongo for Diabetes, Telcare, the iHealth
meter, Sanofi’s iBGStar

29. SMART INSULIN PENS
• InPen (Companion Medical)
• FDA approval 2016, launch expected 2017
• Dosage calculator, logbook, temp. monitor, last dose, IOB
• Tracking & reporting to HCP
• Novolog + Humalog
• ESYSTA Pen (Emperra Digital Diabetes)
• Launched in Germany, submitted to FDA
• Works with Lilly, NovoNordisk, Sanofi insulin
• Has countdown and insulin dosing calculator, sends data to cloud/app

30. DATA MANAGEMENT: PUMP/CGM SPECIFIC
• Medtronic: CareLink
• Dexcom: Clarity
• Animas: DiaSend
• Insulet: Abbott CoPilot
• Tandem: t:connect

31. DATA MANAGEMENT:
CROSS PLATFORM
• Tidepool: nonprofit, open source
• Dexcom, Insulet, Medtronic, Tandem, Animas, Bayer, Abbott, OneTouch
• Blip/Blip Notes: see data from multiple sources in one place
• Nutshell (in beta): historical meal analysis
• Glooko: subscription based
• Sync BG, CGM, physical activity, etc.
• Mobile app (Android or iOS)
• Carb count database
• Send data to cloud/provider
• Personal/clinical advisor available

32. DATA MANAGEMENT: SIMULATION
• Perceptus.org: Free, open source
• Input-driven data analysis
• Can integrate with mLab data
• Basal/bolus optimization
• Mixed meals input
• Exercise input

33. DIABETES APPS:
• Dexcom Share/Follow
• CalorieKing
• Carb Counting with Lenny
• MySugr Diabetes
• MyFitness Pal
• BG Monitor Diabetes
Source: www.gottabemobile.com/best-diabetes-
apps

34. “ARTIFICIAL PANCREAS:” BIGFOOT
BIOMEDICAL
• Founders: Jeffrey Brewer, Lane Desborough, Bryan Mazlish, Jon Brilliant
• Founded in 2014, Acquired Asante Snap assets 2015
• “Smartloop” system: Snap-like pump + Dexcom CGM
• Feasibility study begun August 2016
• Pivotal trial 2017, hope to submit to FDA in 2017 & launch in 2018
• JDRF funding announced 1/26/17
• equity investment through JDRF T1D Fund, a “strategic venture philanthropy fund”
• www.bigfootbiomedical.com/jdrf-t1d-fund/

35. OTHER “ARTIFICIAL PANCREAS” SYSTEMS
• Beta Bionics
• Dr. Ed Damiano (Boston University)
• Bihormonal (insulin + glucagon) + insulin-only systems
• Lancet study released 12/2016: 11 day study of adults, average BG 141 mg/dL
• Future studies include integrated device (iLet), pivotal studies of both types of
devices
• Hope to launch in 2018
• TypeZero Technologies
• University of Virginia
• inControl: smartphone-based AP system
• 28 clinical trials involving 475 patients
• Licensing agreement with Tandem signed in 2016

36. NIGHTSCOUT
• Created in 2013 by Lane Desborough, John Costik, many others
• First remote monitoring software available
• Free, open source, volunteer driven
• CGM in the Cloud FB page: 30,000+ worldwide members
• Supports Dexcom, Medtronic, Libre
• xDrip, Parakeet, Pebble integration
• Nightscout Foundation (go see James and family!!!)

37. NIGHTSCOUT

38. SMART WATCHES
• Pebble (R.I.P.)
• Acquired by FitBit in 2016, immediately shut down (potentially good news though)
• All models supported, large variety of watchfaces available
• Data from Dexcom Share, xDrip, or Nightscout site
• Apple Watch
• myBG, Nightscouter: display data from Nightscout site (App Store); Nightguard: data
from Nightscout site (Github)
• Dexcom Share2, Dexcom Follow, Dexcom G5 Mobile (App Store)
• Garmin
• CGM Loop, CGM Hike/Run/Watch/Edge (Andreas May), G-Force/Look No
Hands/Nightscout Watch (Phimby)
• AndroidWear
• Nightwatch: collects data from Dexcom Share servers, xDrip, or Nightscout site
• Scrollable/zoomable BG graph, customizable levels, 4 watchfaces

39. OPENAPS
• Created by Ben West, Dana Lewis, Scott Leibrand
• Android-based DIY “closed loop” system
• Utilizes open source oref0 algorithm
• Requires Nightscout for monitoring
• Requires older Medtronic pump (Ben West)
• Uses CareLink USB/Raspberry Pi or Intel Edison
• Automatically adjusts basal rate based on CGM reading
• “Meal Assist” feature, Autotune

40. LOOP
• Open source iOS based DIY “closed loop” system
• Created by Nate Racklyeft, maintained by Pete Schwamb, others
• Requires older Medtronic pump
• Uses “RileyLink” as interface between pump/iPhone
• Automatically adjusts basal rate based on CGM readings
• Remote bolus through iPhone app, Apple Watch

41. QUESTIONS?