Emerging Technology

Mary Johnson, RN, BS, CDEDirector, Clinical Research

International Diabetes Center

Park Nicollet and HealthPartners Institute

Minneapolis, MN

Disclosure Statement

Mary L. Johnson has participated in clinical research, or

served as a consultant for:

Abbott

CeQur

DexCom

Hygieia

Calibra/J&J

Lilly

Medtronic Diabetes Care

NIDDK/NIH

Novo Nordisk

POPS! Diabetes Care

Roche Diabetes Care

Sanofi

Overview – what’s new in:

• Insulin Delivery Devices/Insulin Dosing Devices

• Pumps

– Patch Pumps• Infusion Sets

• Adhesives

– Smart Pens

– Devices that advise on insulin dosing

• CGM

• Meters

Insulin Pumps – current/future

• Medtronic MiniMed

– 670G

– 780G

• Tandem T-slim X2

– Basal IQ

– Control IQ

– T:sport

• Omnipod

– Dash

– Horizon

Minimed ™ 670G System

• First FDA approved“Hybrid closed loop” (HCL) - Sept 2016

• FDA approved now for peds age 7+• “Hybrid” means patients still must enter

carbs into pump to bolus• The pump software automatically

increases/decreases insulin delivery • Guardian™ Sensor 3• Guardian™ Link 3 transmitter• Contour® Next Link 2.4 meter• CareLink™ Software

MiniMed™ 670G System Details

• Small insulin boluses every 5 minutes based on sensor glucose

• Target SG of 120 mg/dL (can set Temp Target of 150 mg/dl)

• Doesn’t correct until BG is 150 mg/dl

• Must still carb count and bolus for meal and do SMBG calibrations

• Pump requires minimum of 48 hours in Manual Mode (starting at 12AM) for algorithm to learn the patient’s insulin delivery history

• In Auto Mode, the only settings you can change are carbohydrate ratios and active insulin time

• Accurate Manual Mode settings will remain important

• Achieving TIR of 72%, hypo 3%, hyper 25%

AGP CGM View

CGM Metrics

CGM Profile

CGM Daily View

Accessed from closeconcerns.com 2/21/19

Relationship of TIR to A1c

Manual Mode (“Open Loop”)

• Pump without CGM

• Pump with CGM

• Pump with CGM with

Suspend on low*

• Pump with CGM with

Suspend before low – will shut off if low expected in 30 min

Auto Mode (“Hybrid Closed Loop”)

• Auto Mode with CGM

• Safe Basal

MiniMed™ 670G System Details

*WARNING: Suspend before low and Suspend on low are not intended to be a treatment for low blood glucose. Having insulin suspended when glucose is low may not bring your blood glucose back to your target range for several hours. In that case, you run the risk of hypoglycemia. Always confirm your blood glucose readings with your BG meter and treat according to the recommendations of your healthcare professional.

Coming next from Medtronic – 780G

• Advanced hybrid closed loop

• Automatic correction boluses.

• Goals of >80% time-in-range (70-180 mg/dl), 100% time in closed loop

• Better meal experience

• Remote monitoring

• Software updates (likely via Bluetooth)

• Improved Guardian sensor (non-adjunctive use)

• Expected launch April 2020

Tandem t:slim X2

• CGM: Dexcom G6

• FDA approved for ages 6+

• Touchscreen, remotely updated software

• No calibrations

• Sensor lasts 10 days

• Uses Basal IQ technology– Predictive low glucose suspend – 30 minutes ahead and

suspends if expected to drop below 80 mg/dl. Does not use phone for communication……yet…..will be coming

• First FDA designated ACE (alternate controller enabled) insulin pump

Coming next from Tandem - t:slim X2 mobile app

• Allows users to use the app to view pump status and alerts without pulling out their pump

• App won’t allow control of pump from phone initially

• Allows for automatic upload to t:connect, Tandem’s web-based data application.

• Enable remote monitoring by caregivers

• Potential future features include integration with diet, sleep, exercise info, insulin dosing advice and smartwatch integration

Coming next from Tandem – Control IQ

• HCL Pump

• Anticipated launch summer 2019

• RX required for current X2 users

• No new pump – software update

• Online eLearning in order to unlock upgrade

• Dexcom G6 integration

• Mobile phone app

• Does not require calibrations

• Control IQ will always be on unless patient turns off HCL

Coming next from Tandem – t:sport pump

• No screen

• Half the size of current t:slim

• Very short tubing (“patch” pump) or longer tubing

• 200 units of insulin

• Controlled by phone/handheld device

• On-pump bolus button

• Integrates control-IQ HCl algorithm

• Launch: 2020

Omnipod Dash System

• FDA approved

• Commercially available early 2019

• New PDM- locked down android cell phone

• Free PDM to all current and new users

• Apps for iOS, not yet for Android

• Can see your PDM data on an iPhone but cannot make any adjustments via phone

• New pods needed

• NOT a HCL pump, NOT connected to CGM but to Contour NEXT ONE BGM

• Can utilize DISPLAY™ app to see PDM data and Dexcom data

• Share PDM readings via VIEW ™ app with up to 12 people

J.P. Morgan Healthcare Conference January 2019, Investor.insulet.com accessed 16Feb2019

Coming next from Omnipod - Horizon System

• Anticipated launch 2020-2021

• All DASH features plus– Same Pod only smarter with

on-body analytics

– HCL

– Integrate Dexcom data

– Partnership with Samsung for smartphone controlled system

J.P. Morgan Healthcare Conference January 2019, Investor.insulet.com accessed 16Feb2019

Insulin Pumps – future

• Bigfoot

• BetaBionics

• Tidepool Loop supporting the DIY movement

BIGFOOT BIOMEDICAL“Not an App, Not a Device, But a Cloud Connected Ecosystem”

Beta Bionics

• iLet – Gen 4

• Coming in late 2019 to early 2020– Bi-hormonal pancreas

– Insulin only coming first but 2 chambersalready in the pump (goal of 2022)

– Meal “announcement” but no carb count

– Works with multiple CGM’s

• Currently with Eversense, Dexcom and Libre

– Phone app

– Pre-filled insulin and glucagon cartridges

– Rechargeable battery

– Induction charging

FFL Conference July 2018, www.healthline.com/diabetesmine/beta-bionics-ilet-update#3 accessed 16Feb2019

“Looping” and OpenAPS

• Do it yourself approach

• Uses Dexcom or Medtronic CGM, “legacy” Medtronic pumps or Roche Spirt Combo pumps

• Need CGM, pump, iPhone/computer, radio connector

• Not FDA approved or regulated, more for tech savvy patients

• Tidepool intends to deliver Loop as a supported, FDA-regulated mobile app in the App Store

Tidepool Loop

Loop is hybrid closed loop algorithm that uses bluetooth to communicate with interoperable pumps and CGMs.

• Launch anticipated in 2020• Hybrid closed loop system• Insulet (Omnipod) is first official pump partner, more

partners to come. • Gives patients the ability to choose their devices• Patient can set their own targets

Infusion Sets coming soon..

Capillary Biomedical

• SteadiSet anticipated launch late in 2019• 7 day wear• Adapters for all pump cartridges• Kink free cannula

Medtronic Mio Advance

• All-in-one pre-loaded serter• One handed 90 degree insertion• Hidden needle• FDA approved but not yet available

for US patients

Ancillary supplies to keep devices on for intended wear time

Examples of products that can be used:

Tapes:• Grifgrips• Stayput patches• Simpatch• Expression med • Rock tape• Opsite flexifix• Rockadex• Tegaderm• IV3000• Pump Peelz

Adhesive Prep wipes or liquids:• Mastisol• Skin Tac• IV prep• Cavlion no sting barrier wipes• Cavlion durable barrier cream• No-sting skin-prep• Skin-prep

Adhesive removers:• Detachol• Tac Away• Uni-solve• Sensi-Care

Insulin Patch Pumps

• Patch Pumps–V-Go

–CeQur PAQ

V-Go: Disposable Insulin Delivery

V-Go website: www.go-vgo.com

V-Go: Disposable Insulin Delivery

• Patient uses once a day and then replaces with another the next day

• Patients fill V-Go with U-100 short-acting insulin (Novolog or Humalog)

• Patient applies V-Go, basal insulin flow begins after insertion

– Gives basal rate of 20, 30, or 40 units total per day

• To deliver a bolus dose of insulin, patient presses Bolus Button (each “click” = 2 units)

– Bolus up to 36 units per day (or up to 12 units per meal)

V-Go Dosing

V-Go website: www.go-vgo.com

CeQur – PAQ basal and bolus

• 7 basal dose options: 16, 20, 24, 32, 40, 50, or 60 units per day, mainly T2D

• On-demand bolus dosing

– 2 units per dose

• Delivers up to 330 units of rapid-acting insulin over 3 days

• EU only; pending in US

CeQur Bolus Patch

• Insulin patch pump worn for 3 days

• Gives bolus insulin only

• Holds up to 200 units of rapid-acting insulin

• Boluses in 2 unit increments

• Can bolus through clothing

• Formerly owned by Calibra – Finesse bolus patch – FDA approved

Optimizing Basal-Bolus Therapy in T2D: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using

an Insulin Patch vs. an Insulin Pen

987-P ADA 2018 Basal:Bolus T2D: Pen or Patch Bergenstal, RM et. al.

710-P ADA 2018 Insulin Titration Algo: Patient Glucose Diary Pen vs Patch Bolus Insulin Delivery Johnson, ML et. al.

995-P User- and Healthcare Provider-Reported Outcomes for a Wearable Bolus Insulin Delivery Patch Peyrot M. et al.

Calibra patch now CeQur bolus patch

• T2D• Basal Ins• Not at

A1c goal

710-P ADA 2018 Insulin Titration Algo: Patient Glucose Diary Pen vs Patch Bolus Insulin Delivery Johnson, ML et. al.

T2D Basal Bolus Titration with SMBG Patterns

Weekly Adjust Usual Basal & Bolus doses based on SMBG patterns for the week

Dose correction at each meal for:• Meal Size

o Smaller than usual -2 unitso Larger than usual +2 units

• Meal glucose level o <70 - 2 units o >180 + 2 units

Snack with CHO: take 2 units

987-P ADA 2018 Basal:Bolus T2D: Pen or Patch (Calibra) Bergenstal, RM et. al.

BL

D

Bed

B L D Bed

Basal to Basal: Bolus Insulin in T2D N=98

Basal Basal: Bolus

IDC data on file. TIR = Time in target range 70-180mg/dL

TIR 45% TIR 75% 1% <54mg/dL

Insulin pen technology

• InPen:“Pump technology for pen users”

o FDA approved, commercially available

o Wireless, reusable insulin pen connected to phone app

o Automatically calculates insulin doses (including IOB)

o Missed dose reminders

• Gocap:o Cap that fits on any insulin pen

o Keeps track of insulin doses

o Wireless, reusable pen cap connected to phone app

o Can be stored and shared

More smart pens to come from:

-Bigfoot Biomedical

-NovoNordisk

-Lilly

-Sanofi

Hygieia d-Nav

• FDA approved

– Glucose meter

– Embedded insulin dosing software

– Basal, bolus, pre-mixed insulins

– Currently being used by BCBS – Michigan

• App just approved

40

Diabetesvol. 65supp. 1

2016

Insulin Therapy Transformation in Northern Ireland Roy Harper1, Rosemary Donnelly1, Israel Hodish2

1 South Eastern Health and Social Care Trust, Belfast, NI; 2 Hygieia, Inc., Ann Arbor, Michigan.

`

Mean ± SD

Insulin Dose Guidance +

HCP-S n=93

HCP-Sn=88

Attrition 6 (6.5%) 7 (8.0%)

Gender (women) 47 (50.5%) 40 (45.5%)

Age (years) 61.7±9.4 58.8±10.5

Duration of diabetes (yrs.) 16.1±7.4 15.3±6.0

BMI (kg/m2) 34.7±5.1 34.9±5.0

Baseline A1c (%) 8.7±0.8 8.5±0.8

D-Nav study in US (IDC, Henry Ford, Iowa Diabetes Research)

2018 ADA 353-OR, Digitally Enhanced Insulin Therapy – A Multicenter Clinical Trial, Hodish, I et al

A1C Changes During the Study

-1.0

-0.3TECHNOLOGY + HCP SUPPORT HCP SUPPORT

A1

C (

%)

A1C Changes During the Study

A1C Changes During the Study

P<0.0001

Study Results: Dosage Changes + SEM

Study Enrollment, 0.77

Study Completion (6 months), 1.24

Study Enrollment, 0.71

Study Completion (6 months), 0.76

STUDY ENROLLMENT STUDY COMPLETION (6 MONTHS)

Tota

l Dai

ly I

nsu

lin

Un

it/k

g/d

ay

Total Daily Insulin per Body Weight

Technology +HCP HCP

P <0.0001

Dose adjustment per week: 1.1+0.2Of these, down titration per week: 0.2+0.3

DreaMed Advisor Pro

• FDA approved

• Working with Glooko

CGMS– current/future

• Abbott

– Libre

– Libre with LibreLink

– Libre2

• DexCom

– G6

– G7

– G6 program for Type 2

– Pro Q

• Medtronic

– Guardian Connect

– Multiple options

• Senseonics

– Eversense

– Eversense XL

– Eversense 365

FreeStyle Libre

• Factory calibrated (no fingerstick BG required)

• 14 day wear

• Measures glucose every minute and records readings every 15 minutes

• Displays most recent 8 hours of data with arrows

• Has built in Precision Neo meter (1 hr warm-up time)

• LibreLink app for iOS (iphone7 and later), android OUS

• If you want to switch between reader and phone, have to activate with reader

FreeStyle Libre CGM with LibreLink Mobile App

Phone app replaces need for reader. Mobile phone scanned glucose readings auto downloads into cloud database.

• Can be used with 10 day or 14 day sensors

• Factory calibrated (no fingerstick BG required)

• Same 1 hour warm up for 14 day sensors

• Has arrows but no alarms

• No need for reader if patient is using phone**ONLY for patients with iPhone 7 (or greater)

Android app in the works

Coming next from Abbott/Freestyle…

Freestyle Libre 2• CE mark, fall 2018

• Customizable threshold alarms - hypo and hyper - sent to reader

• Notifies if signal loss

• Sound or vibration or “off”

• No additional cost

Dexcom G6

• Approved March 2018

• Factory calibrated (no fingerstick BG required)

• 10 day wear

• No acetaminophen interference (at usual doses)

• Age 2 and older

• Can share with up to 5 “followers”

• MARD 9.0%

• First FDA approved “iCGM” (new class: integration with other devices/platforms)

Coming next for Dexcom…

G6 glucose program

• Designed for T2 population

• Removes high/low glucose alerts

• Currently just for Samsung J3 users

• In-app chat with wellness coach

Dexcom and Type Zero acquisition

• Insulin dosing advice algorithms

diatribe.org whats-coming-dexcom-2020-low-cost-slimmer-fully-disposable-cgmAccessed 17Feb2019

Coming next for Dexcom

Dexcom G7 Pro Q professional CGM• Professional version of G6

• HCP’s/clinics own the devices

• Launch in 2019

• Approved for ages 2+

• Fully disposable

• No picture available yet

• Launch anticipated in 2020• Fully disposable, New applicator• 14-15 day wear• Reduced cost• Sends data to phone/may not need to

purchase receiver – foresee different phone apps for different populations

Medtronic - Guardian Connect CGM

• Approved March 2018

• Requires at least 2 calibrations/day

• MDI patients

• 7 day wear

• Predictive low/high alerts, up to 60 min prior

• Only works with Apple for now (Android launch in 2019)

• Combines with SugarIQ app

Coming next from Medtronic…

• Mobile app for pump users

• Fully disposable CGM

• No calibration CGM

• Longer wear, 10-14 day goal

• Combo sensor/infusion set with extended wear

• Fully disposable Professional CGM without need for calibrations

Eversensefrom Senseonics

• 2 calibrations per day

• 90 day use (180 days in Europe)

• Sensor charged by transmitter placed on skin

• Transmitter vibrates for alarm (mobile app also has predictive alarms)

• Remote monitoring

• Glucose data sent directly to clinic’s cloud

• Can safely be worn during MRI scans

Coming from Senseonics…

• Eversense XL (180-Day) - Same as Eversense, but 180-day implantation

• Eversense 365 (365 Days)

• No calibrations

• Integration with insulin pumps

NEW in the world of blood glucose meters

• All in one meters (Dario, Pops!)• Subscription Programs (out of

pocket); test strip delivery to your door (Livongo, One Drop)

• Meters now send data wirelessly to mobile phone app

• Meters with insulin advisor (Accuchek Connect with app)

• More brands of blood ketone meters (Precision Xtra, Nova Max Plus)

• Data sent to clouds

IDC Team

Thank you!

mary.l.johnson@parknicollet.com