T1D and Technology talk delivered by Clayton McCook, DVM at the 2019 TypeOne Nation Summit on 2/23/2019 in Tulsa, OK.

1. 2019 TYPE ONE NATION SUMMIT
TULSA, OKLAHOMA
2/23/2019
TECHNOLOGY & T1D
CLAYTON MCCOOK, DVM
T1D PARENT

2. INTRODUCTION
• Personal information/background
• Our family/our Lily
• Personal introduction to diabetes technology
• Disclaimer/financial conflicts of interest
• YDMV disclaimer
• Slideshare: https://www.slideshare.net/cdmccook/2019-type-one-nation-
tech-presentation

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)
• A Sweet Life blog (www.asweetlife.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
• JDRF Open Protocol Initiative
• Tidepool Loop

5. PUMP TECHNOLOGY
• Insulet
• Medtronic
• Tandem

6. 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)

7. INSULET FUTURE PLANS
• Omnipod Dash Touchscreen
• Bluetooth- and WiFi-enabled PDM/mobile app
• Able to see IOB, set bolus/basal
• Data sent to user/caregiver phone
• FDA approved, launch this year
• Omnipod Horizon Automated Glucose Control System
• Algorithm integrated into pod
• Hybrid closed loop
• Investigational study on algorithm in adults completed
• Expected launch in 2020

8. 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

9. MEDTRONIC MINIMED 670G
• FDA approval granted Sept. 2016
• Approved for ages 7 and up
• 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

10. MEDTRONIC FUTURE PLANS
• MiniMed 780G automated insulin delivery system
• Automated correction boluses for hyperglycemia
• Bluetooth connectivity
• Remote monitoring for caregivers
• Software updates
• Expected upgrade of Guardian Sensor 3 CGM (no fingersticks)
• Hope to launch by April 2020

11. TANDEM T:SLIM X2 W/BASAL-IQ
• Smallest insulin pump on market, 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)
• Integration with Dexcom G6
• PLGS (predictive low glucose suspend)
• 300 U capacity

12. TANDEM T:SLIM X2 W/BASAL-IQ SUCCESS

13. 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

14. TANDEM FUTURE PLANS
• Second-generation Tandem system (“hybrid closed loop”)
• Control-IQ
• Utilization of Dexcom G6 sensor & TypeZero Technologies algorithm
• University of Virginia (more later)
• Data generated from ongoing trial, hope to launch summer 2019
• Pilot trial data: patients in range (70-180 mg/dl) 87% w/1.1% hypoglycemia

15. TANDEM FUTURE PLANS
• t-Slim X2 mobile app: t-Slim Connect
• Mobile display smartphone app
• Connects to pump via Bluetooth
• Displays pump status and alerts
• Uploads to t-Connect automatically

16. TANDEM FUTURE PLANS
• t:sport insulin “patch” pump
• Screenless design, controlled via smartphone
• Half the size of X2 (holds 200U of insulin)
• Integration with Control-IQ
• Bolus button on pump

17. TANDEM ACE DESIGNATION
• Announced 2/14/19 by FDA
• ACE = “alternate controller enabled”
• Allows integration with:
• CGM systems, algorithms, blood glucose meters, software platforms
• Doesn’t require lengthy FDA approval process
• Will allow for integration of new/improved CGMs, etc.

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

19. 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, touchscreen available
• 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

20. 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

21. • 10 day wear (can be restarted w/DIY instructions)
• No fingerstick calibration required
• No receiver necessary (smartphone)
• Smaller, slimmer transmitter design
• 90 day transmitter life
• Next-generation inserter: push-button
DEXCOM G6

22. 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

23. • Dexcom G7 (collaboration with Verily)
• Thinner, less expensive, fully disposable
• 14-15 day wear
• No fingersticks required
• Data straight to smartphone (similar to G6)
• Available to type 1 and type 2 patients
DEXCOM FUTURE PLANS

24. • Insulin dosing advice for PWD on injections
• CGM-based mealtime (bolus) calculator
• Forward-looking hypoglycemia prediction
• Sleep and exercise advice
• Based on TypeZero algorithm (acquired by Dexcom)
DEXCOM FUTURE PLANS

25. MEDTRONIC CGM
• Guardian Sensor 3
• FDA approval 2016, launched in 2017
• 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
• FDA approval 10/2017
• Small sensor worn on arm (about quarter size)
• 2 week wear, no fingerstick calibration
• Approved for dosing insulin
• Scanned for data with handheld reader
• 1 hour warm-up time
• Remote monitoring available
• Bluecon by Ambrosia Systems: https://www.ambrosiasys.com/
• Nightscout/Glimp: http://www.nightscout.info/wiki/welcome/nightscout-
for-libre

28. FREESTYLE LIBRE LINK
• Smartphone serves as scanner
• View current reading, trend arrow, history
• Trends and patterns reports available
• LibreView allows healthcare providers to access data
• Remote monitoring via LibreLinkUp

29. 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

30. SMART INSULIN PENS
• InPen (Companion Medical)
• FDA approval 2016, now available
• Dosage calculator, logbook, temp. monitor, last dose, IOB, tracking &
reporting to HCP
• Novolog + Humalog
• NovoPen 6/NovoPen Echo
• Expected launch in 2019 (available in Europe)
• Reusable pens with electronic screen and NFC technology
• Shows IOB, size of last dose, time since injection
• 800 dose injection memory + 5 year battery life
• Compatible with long- and short-acting insulins
• Will work with Glooko, mySugr, Dexcom in future

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

32. 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

33. 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

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

35. BIGFOOT BIOMEDICAL
• Founders: Jeffrey Brewer, Lane Desborough, Bryan Mazlish, Jon Brilliant
• Founded in 2014, Acquired Asante Snap assets 2015
• “Smartloop” system: Snap-like pump + Freestyle Libre
• Pivotal trial w/Libre to begin in 2018
• Hope to launch in 2020
• JDRF funding announced 1/26/17
• equity investment through JDRF T1D Fund, a “strategic venture philanthropy fund”
• www.bigfootbiomedical.com/jdrf-t1d-fund/

36. 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
• Single hormone pivotal trial 2019, hope to launch by 2020
• TypeZero Technologies
• University of Virginia
• inControl: smartphone-based AP system
• 28 clinical trials involving 475 patients
• Licensing agreement with Tandem signed in 2016
• Acquired by Dexcom in 2018

37. NIGHTSCOUT
• Created in 2013 by Lane Desborough, John Costik, Ross Naylor,
many others
• First remote monitoring software available
• Free, open source, volunteer driven
• CGM in the Cloud FB page: 65,000+ worldwide members
• Supports Dexcom, Medtronic, Libre
• xDrip, NightWatch, Parakeet, Pebble integration
• Nightscout Foundation

38. NIGHTSCOUT

39. SMART WATCHES
• Pebble (R.I.P.)
• Acquired by FitBit in 2016, immediately shut down
• All models supported, large variety of watchfaces available
• Data from Dexcom Share, xDrip, or Nightscout site
• Fitbit Ionic and Dexcom (supposed to launch in 2018)
• 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)
• SugarMate
• 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

40. OPENAPS
• Created by Ben West, Dana Lewis, Scott Leibrand
• Android-based DIY “closed loop” system
• Utilizes open source oref1 algorithm
• Requires Nightscout for monitoring
• Requires older Medtronic pump (Ben West)
• Uses CareLink USB/Raspberry Pi/Intel Edison
• Automatically adjusts basal rate based on CGM reading
• “Meal Assist” feature, Autotune, Autosens, “Super Micro Boluses”

41. 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

42. JDRF OPEN PROTOCOL INITIATIVE
• Announced 10/2017
• Seeks to help overcome challenges in use & adoption of open-protocol
systems
• Help to establish clear financial, regulatory and legal frameworks
• Coordinate w/regulators & legal advisors to develop a predictable pathway
to FDA review
• Encourage manufacturers to update communication protocols on their
devices to enable:
• Seamless, secure connectivity with other devices (by using Bluetooth, e.g.)

43. TIDEPOOL LOOP
• Announced November 2018
• Funding from Helmsley Charitable Trust + JDRF
• Goal: deliver FDA-regulated, broadly available Loop app via App Store
• Compatibility with at least one, and hopefully more, in-warranty pumps
• Omnipod = only current pump in pipeline
• Huge potential with ACE designation
• Exciting hires: Pete Schwamb & Katie DiSimone

44. QUESTIONS?
#Insulin4All