2017 TYPE ONE NATION SUMMITTECHNOLOGY UPDATECLAYTON MCCOOK, DVMT1D PARENT

INTRODUCTION

• Personal Information/Background

• Our family/our Lily

• Personal introduction to diabetes technology

• Disclaimer/Financial Conflicts of Interest

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

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

PUMP TECHNOLOGY

•Animas•Insulet•Medtronic•Tandem

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

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

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

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

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)

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

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)

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

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

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

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

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

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

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)

CGM TECHNOLOGY

• Dexcom• Medtronic• Abbott Freestyle Libre

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

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

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)

• 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

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

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

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

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

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

DATA MANAGEMENT: PUMP/CGM SPECIFIC

• Medtronic: CareLink

• Dexcom: Clarity

• Animas: DiaSend

• Insulet: Abbott CoPilot

• Tandem: t:connect

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

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

DIABETES APPS:

• Dexcom Share/Follow• CalorieKing • Carb Counting with Lenny• MySugr Diabetes• MyFitness Pal• BG Monitor Diabetes

Source: www.gottabemobile.com/best-diabetes-apps

“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/

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

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!!!)

NIGHTSCOUT

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

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

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

QUESTIONS?