The document outlines various advancements in diabetes technology and management presented at the 2019 Type One Nation Summit in Tulsa, Oklahoma. It covers innovations such as insulin pumps, continuous glucose monitors, smart syringes, and mobile applications, along with future plans from companies like Medtronic, Tandem, and Dexcom. The discussion emphasizes the integration of technology for better diabetes management and introduces DIY systems and upcoming products designed to improve patient care.

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