New Technologies for

DiabetesClaire Baker, MD

Diabetes & Endocrine Associates

Omaha, NE

March 25, 2017

Disclosures / Caveats Some of the products/technology mentioned are only

available in Europe and not yet FDA approved

Many of the products are currently under FDA review and are not yet approved

Some of the technology and products mentioned are created by the diabetes patient community and haven’t been approved by the FDA or tested in clinical trials Use at your own risk

USA launch goals are mentioned when known, but many factors impact approval and availability It’s hard to find accurate info on USA availability when products

aren’t yet FDA approved

Learning Objectives List some of the apps that patients can use to

manage their diabetes

List some of the programs that can help you analyze

your patients’ glucose data

Describe how continuous glucose sensors work

Explain how insulin pumps work

Identify the parts necessary for a bionic (artificial)

pancreas

Discuss how new technologies will improve the lives

of diabetics

Definitions Bluetooth: Short range wireless that connects cell phones,

computers, printers, some medical devices, and other electronics

iOS: The operating system used by Apple phones (iPhones)

Android: An operating system maintained by Google for cell phones

CGM: Continuous Glucose Monitor

HCP: Health Care Provider

CDE: Certified Diabetes Educator

RNs, RDs (dietitians), Pharmacists, or MDs who have an extra certification in diabetes education

Patient Apps: Nutrition and

Weight Management CalorieKing: iOS

Free food database.

MyFitnessPal: iOS and Android

Free

Track food and weight

Nutrino: iOS and Android

Will tailor recipes and give you suggestions for dining out based on your food preferences

Suggestic: iOS

Nutrition coaching

CalorieKing

MyFitnessPal

Patient Apps: Logging or Record

Keeping

Glucose Buddy

Diabetes Pedometer

MySugr

Diabetes Connect

Sugar Sense

Diabetes and Blood Glucose Tracker (iOS)

Diabetes and Diet Tracker (Android)

Patient Apps: Glucose Buddy

iOS and Android

Free

Lets you log glucose, carbs, doses, A1C results, and

exercise

A website syncs with iOS

Does not sync with meters, CGMs, or pumps

Glucose Buddy

Patient Apps: Diabetes

Pedometer

iOS only

Diabetes log (glucose entry,

insulin, carbs)

Step counting

Easy entry

Patient Apps: MySugr iOS and Android

Log glucose, carbs, and insulin

Provides motivating feedback and challenges

Generates reports for HCP

Doesn’t sync with meters or pumps

Free though a paid Pro version adds PDFs and

diabetes coaching

MySugr

Patient Apps: Engine1 For Type 1 Diabetics or those on

advanced insulin regimens

Real-time decision support for

exercise

Best times to exercise, how much

carb to eat, exercise intensity

Your account can link to their

website for deeper analysis

Need a Pro account for advanced

features: $69.99 for 1 year

Only for the tech savvy

Accu-Chek Aviva

Connect Meter Meter automatically syncs to

your phone

You can then review glucose data on the phone and on a website

The phone app has a bolus calculator that your HCP needs to set-up

You need to tell it how much you’re eating and it takes that into account plus your before meal blood sugar

OneTouch Flex Meter with

OneTouch Reveal App OneTouch Flex meter will

wirelessly sync to the

OneTouch Reveal App

The app can also be used by

manually inputting data

PDF reports can be

generated to be shared with

HCP

One Drop System One Drop Chrome Blood Glucose Monitoring System

$99.95 for: Meter, Lancing Device, 10 Lancets, 100 Test Strips, and Carrying Case

One Drop App (iOS and Android)

Free

Syncs with the One Drop Chrome meter

One Drop Premium

$39.95 per month

Includes One Drop app, unlimited test strips (based on actual use) delivered to you, and 24-7 in app text support from CDEs

One Drop Professional: Links to patients using One Drop

Up and coming

One Drop

Patient and Provider Software:

Tidepool Free for patients and HCPs

An uploader that works with several devices and pools the data in one spot

Patients can also access the software: Blip

Supported devices: Dexcom, Omnipod, Tandem, Medtronic, Animas, Contour Meters, Freestyle Meters, OneTouch VerioIQ

Patient and Provider Software:

Glooko

MeterSync device syncs with

over 50 different devices

For patients annual

subscription of $59.95

includes a MeterSync

Connected / Smart Insulin Pens Attach to or replace your insulin pen and then track data

The simplest tell when the last injection was

Helps prevent duplicate dosing or allows you to make up for forgotten injection

The more complex and connected send data to cell phones and potentially share with companions and HCPs

Missed dose alerts to patient and potentially caregivers

Help analysis glucose data and make dose decision

Temperature sensors

Simplify logging

Improve adherence

Companion Medical InPen Battery will last 1 year

Connects with a smartphone app

Dose calculator that recommends optimal dosing

A logbook to track history and timing of doses

Monitoring of insulin temperature

Display of the last dose and insulin-on-board

Tracking and reporting to your health care provider

Versions for both NovoLog and Humalog

FDA Approved in 2016

Timesulin Shows how much time has

elapsed since your last

insulin shot

Replaces the normal pen cap

When you remove it to give

an injection, the timer starts

1 year battery life

$6.99 on Amazon

Common Sensing’s Gocap Collects data and sends it to a smartphone app, and it can also be sent to a

data aggregator or a caregiver

Charge weekly

Logs doses from any disposable prefilled insulin pen

Doses are displayed on the screen and automatically logged to a smartphone app

Can set reminders and alerts

Temperature detection

Wireless communication with some meters and an app

Dose calculator

Not yet FDA approved

Common Sensing’s Gocap

Other Connected / Smart

Insulin Pens InsulCheck: Similar to Timesulin

Order from the UK

Insulog

Snaps onto an insulin pen and logs doses

Streams data via Bluetooth to a companion app

FDA approval pending

Insulin Patch Pumps Wearable plastic devices with reservoirs that hold insulin,

simplifying access for daily insulin dosing

Simplified versions of electronic insulin pumps

Currently Available:

V-Go

Up and Coming

Imperium Patch Pump (prefilled)

CeQur Paq (3 day insulin delivery, 7 possible basal rates)

OneTouch Via (bolus insulin only)

BD Insulin patch pump (few details available)

V-Go Insulin

Delivery Device

Holds short acting insulin

Fill with insulin and change every 24 hours

Disposable: use a new one each day

A ”floating” metal needle is inserted under the skin when the V-Go is put on

Gives 20, 30, or 40 background units of insulin per day

This is released in small amounts over 24 hours

Has 36 units of insulin available to take before meals

This is done via “clicks”

Each click is 2 units, so there are 18 ”clicks” available for meals

For Type 1 and Type 2 diabetics

OneTouch Via

3 day wear

Holds 200 units of fast acting insulin

Bolus in 2 unit increments

Patient injects long acting insulin separately

Possible launch late 2017

CeQur Paq

3 day wear

Holds 330 units of insulin

7 possible basal rates (16 – 60 units)

Bolus in 2 unit increments

Uncertain USA launch date

What are Insulin Pumps? Computerized devices (cellphone sized) that deliver short

acting insulin via a flexible plastic tube, called a catheter

Insulin is delivered in two ways A continuous basal or background infusion. It is programmed

into the pump and is delivered in small amounts every few minutes

Boluses that the patient delivers before eating and to correct high sugars. The patient must initiate these

The catheter is inserted via a needle. This infusion site is changed every 3 days.

Currently pumps aren’t automated and require a lot of input and monitoring by the patient

The Omnipod (a tubeless pump)

A Minimed pump

Insulin Pump Settings Basal rate

Carbohydrate ratio

How many grams of carb one unit of insulin will cover

Total grams of carb eaten are divided by the number to determine the mealtime dose

Correction factor or insulin sensitivity factor

How many points of glucose one unit of insulin will drop the blood sugar

Determines how much insulin is given to fix highs

Target

Determines how low the pump tries to get your sugar

Major Pumps Currently on the

Market

Minimed: 530G, 630G, and 670G insulin pumps

Older models: Paradigm and Revel

OneTouch (Animas): OneTouch Ping and Animas Vibe

Tandem: t:slim and t:flex insulin pumps

Accu-Chek Spirit Combo insulin pump

Omnipod (the only tubeless pump)

Continuous Glucose Monitors or

Sensors (CGMs) A small sensor worn under the skin that continuously monitors

interstitial glucose

Glucose is measured every 5 minutes

Depending on the device, fingersticks need to be done 2 – 4 times a day to calibrate the sensor and to check for discrepancies

Especially common when sugar is rapidly changing or with hypoglycemia

An external transmitter sends the data to a receiver, which is either a separate device, a smartphone, or an insulin pump

The receiver can then alert patients to high and low blood sugars, and predictive alerts are possible

Some systems allow for remote monitoring, where patients can share glucose data with caregivers and family

Dexcom CGM Depending on device model, it

will send data to:

A receiver

An iPhone and Apple Watch

An insulin pump: OneTouch

Vibe or t:slim G4

7 day wear

2 calibrations daily

Can share data with others

Can upload data to Clarity so

you can review and analyze

HCPs can access Clarity

Dexcom Sharing: Clarity Dexcom G5

users can share

data with others

HCPs can also

access Clarity

data in the clinic

clarity.dexcom.com

Using Dexcom for Treatment

Decisions

When to use meter instead of Dexcom reading

Symptoms don’t match CGM

You’ve recently taken acetaminophen (Tylenol)

Calibration is due

When in doubt

No number or arrow

Avoid insulin stacking

Wait at least 2 hours between injections or boluses of

correction insulin

Insulin boluses can be adjusted to account for the

glucose trend as well as for the current blood sugar.

Comparison of Different

Treatment Modalities

for Type 1 Diabetes, Including

Sensor-Augmented

Insulin Regimens, in 52 Weeks

of Follow-Up:

A COMISAIR Study

DIABETES TECHNOLOGY &

THERAPEUTICS

Volume 18, Number 9, 2016,

1-7

Dexcom CGM: Anticipated

Improvements Recent news: FDA approved for non-adjunctive use, meaning it can

be used for mealtime dosing

Medicare coverage for Dexcom now anticipated

Improved touchscreen receiver

Android compatibility

Enhanced app that will accept insulin data from other devices

Dexcom G6: longer wear and improved accuracy

Once daily calibration

No interference with acetaminophen (Tylenol)

Dexcom Disposable (partnering with Verily)

At launch, quarter sized and 14 days (possible 2018). Hopes for M&M sized by 2020

No calibrations

Minimed Enlite Currently works with

Minimed pumps

Can set high and low alerts

as well as predictive alerts

With current Minimed pumps,

it can suspend insulin

delivery when lows are

detected or predicted

Minimed CGM: Anticipated

Improvements

Minimed Guardian Connect (currently under FDA

review)

CGM that can be worn without needing an insulin pump

Will connect with a smartphone app (iOS first, Android

later) and enable sharing with others

Will connect with the Sugar IQ App, using analytic and

computational skills to analyze glucose data

Flash Glucose Monitor: Freestyle

Libre

A small glucose sensor

inserted under skin

14 day wear

No fingerstick calibrations

required

Stores data

Currently only a professional version available in USA

The device needs to be scanned to access the data, so no real-time alerts or alarms

In Europe a patient version is available where patients get the sensor and a reader

BluCon Add-On for

Freestyle Libre Attaches on top of the Libre sensor and sends the readings to a

phone app

Trans Am

Waterproof

Works for 14 days

Single use: replace with each Freestyle Libre sensor

Approx. $30 a device

Nightrider

Reusable with replaceable battery

Needs armband or tape to stay in place

Not waterproof

$110 each

Implantable CGM: Senseonics

Eversense

An implantable sensor: under

the skin of the upper arm

Changed every 90 days

Removable transmitter that

has on-body vibration alerts

Not yet FDA approved.

USA launch goal late 2017 or

2018

JDRF’s Artificial Pancreas Project Launched 2006

Goal of automating, via technology, insulin delivery mimicking normal physiology as closely as possible and maintaining normal glucose levels

Necessary components

Insulin pump

CGM

Fast acting insulin

Computer algorithm

Glucagon infusion would be needed for the ideal system

Glucagon raises blood sugar. It is the counter-hormone to insulin

Things to improve: Pump precision, CGM accuracy, rapidity of insulin, size of devices, tape/site sensitivity, device wearability and durability, cost, insurance coverage

Integrating Insulin Pumps and

CGMs

Pumps that display CGM data

These pumps on the market can do this, depending on

which model you purchase: Minimed, OneTouch, and

Tandem

Other pump companies nearing integration

Pumps that act on CGM data

Currently only Minimed pumps do this

Other pumps with integration will become available

1 2 3

4 5 6

First Generation

Very Low Glucose:

Insulin Off:

Pump shuts off

when user not

responding to low-

glucose alarm

Hypoglycemia

Minimizer:

Predictive hypoglycemia

causes reduced or

stopped insulin delivery

before low threshold

Hypoglycemia/

Hyperglycemia

Minimizer:

Same as #2 but also

allows insulin dosing

above a high threshold

Second Generation Third Generation

Automated Basal/

Hybrid Closed Loop:

Closed loop at all times

w/ meal time manual

bolusing

Fully Automated Insulin

Closed Loop:

Manual meal-time bolus

eliminated

Fully Automated Multi-

Hormone Closed Loop:

Insulin and glucagon

infusions

Increasing levels of automation

Auto mode:

Automatically adjusts

basal insulin delivery

based on sensor

glucose readings to help

the patient stay in their

target range.

Suspend before low:

Suspends insulin

delivery before

glucose levels reach a

pre-set low.

Suspend on low:

Suspends insulin

delivery when

glucose levels reach a

pre-set low limit.

The MiniMed 670g systemSMARTGUARD™ HCL TECHNOLOGY

How does the Auto mode feature work?AUTOMATED BASAL INSULIN DELIVERY

Auto Mode automatically adjusts basal insulin

delivery based on sensor glucose readings to help

stay within target glucose range.

Uses pump with CGM for 48 hours for first activation of

Auto Mode

Delivers automated basal insulin doses every 5 minutes

Automated basal target = 120 mg/dL

Temporary target of 150 mg/dL can be used

Bolusing & Meals

Must enter blood glucose (BG) readings and/or

carbohydrate grams

How does the suspend before low feature work in manual

mode?

Suspend before low suspends insulin delivery before

glucose levels reach a pre-set low, without alerting the

user, helping to further address lows.

Example Low Limit = 60

mg/dL

Insulin suspension

occurs when SG < 130

mg/dL and based on

rate of change,

predicted to reach 80

mg/dL in 30 minutes.

Automatically resumes

when SG reaches 80

mg/dL and predicted to

reach 100 mg/dL in 30

min, and has been

suspended for 30 min.

Details of the Pivotal trial for Minimed 670G System

Non-Randomized study DESIGN*

1Bergenstal R, et al. Poster presented at the 76th Scientific Sessions of the American Diabetes Association,

June 10-14, 2016, New Orleans. LA. P-99. Bergenstal R, et al, JAMA. ePub ahead of print, September 15,

2016. doi:10.1001/jama.2016.11708

Study Design

Multicenter: 9 sites in US &

1 site in Israel

Single-arm (no control

group)

Non-randomized

Patients

N=124

Type 1 ≥ 2 years

A1C < 10%

Ages 14-75 yr

Pump therapy ≥ 6 months, with

or without CGM

Study Protocol

RUN-IN PERIOD

Pump + CGM

2 weeks

STUDY PERIOD: Auto Mode3 months

Day 1: HCL

Training

(Auto Mode)

Day 7: Auto Mode turned

ON

Safety of a Hybrid Closed-Loop

Insulin Delivery System in

Patients With Type 1 Diabetes

JAMA. 2016;316(13):1407-1408.

Other Anticipated Hybrid Systems Tandem t:slim X2 + Dexcom: late 2017 or early 2018

Bigfoot Biomedical

Beta Bionics iLet: Will have both an insulin only and an insulin plus glucagon pump

The only hybrid that will include glucagon

Animas + Dexcom to create the HHM: Hypoglycemia-Hyperglycemia Minimizer

Current newest innovation is the OneTouch Vibe Plus, which integrates with the Dexcom G5

HHM: Possible launch late 2018 or early 2019

Tubeless (Insulet): Omnipod Horizon + Dexcom Sensor + Android based handheld receiver.

Trial planned for 2018. Launch goal 2019

Omnipod Dash Omnipod is the only tubeless

pump

Currently it’s controlled with a PDM: which functions as the meter and the controller

The Dash will have Bluetooth pods and will be controlled with a locked down Android device

The Android device will also communicate with meters and Dexcom

Eventually a hybrid closed loop system will be available

Tandem T:Slim X2

T:Slim X2 is their newest pump with Bluetooth capability

Hopes to integrate with Dexcom G5 later this year

One of Tandem’s other pumps integrates with the Dexcom G4

Can upgrade with software downloads rather then purchasing a new pump as the new automated algorithms are released

Predictive low glucose suspend may launch late 2017

Working with the TypeZero Technologies to create a hybrid closed loop system, hoping for 2018 launch

Regulatory and Other Concerns

Traditional pathway: One company develops and sells the entire system

Alternate pathway: Different companies develop and sell different components

Who is the responsible party for successes and failures and keeping system functional?

CGM developer?

Pump developer?

Algorithm developer?

App / software developer?

Regulatory and Other Concerns

Devices must continue to be functional, safe, and

compatible as other components are modified

This includes computer and cellphone updates

Cost and insurance coverage are always concerns

Cybersecurity

If newly diagnosed patients placed on an Artificial

Pancreas, will they understand how to use insulin and

manage diabetes when/if their device fails?

DIY Solutions Created in the diabetes patient community

Facebook groups, on-line message boards

Not FDA tested or fully studied: Use at your own risk

Focus on connecting data across systems (phone, CGM, pump, etc) and/or creating closed loop systems

Some options:

OpenAPS

Loop: https://github.com/LoopKit/Loop/releases

Uses an iPhone and a RileyLink

HAPP

AndroidAPS

Nightscout

Cautions: Past Errors in Creating

Hybrid Systems

Modified artificial pancreas software code was

incompatible w/ a rarely used insulin pump setting

caused incorrect value for IOB (insulin on board)

Artificial pancreas designed so users hit bolus button

when intending to input meal data

Software that incorrectly calculated small insulin doses

required for children not discovered until a serious

adverse event

OpenAPS Open Artificial Pancreas System Project: OpenAPS.org

Designed by the diabetes patient community, so not tested or FDA approved

Will automatically adjust pump basal rate

Patients need to administer their own boluses

You need an insulin pump, a CGM, a lot of technical expertise, and:

a centralized controller operating on commodity hardware (such as a Raspberry Pi mini-computer) that has USB and wireless communication abilities

a USB or Bluetooth connection capable of reading from a Continuous Glucose Monitor (CGM)

a translator device (such as a Carelink USB) with wireless connection capable of reading from and issuing temporary basal commands to an insulin pump

Optional: a wireless Internet connection (i.e. cellular data or Wi-Fi) capable of uploading BG, pump, and operational data.

You will void the warranty of your pump

What OpenAPS Looks Like

Nightscout Allows remote monitoring of CGM

Open-source, DIY project that allows real time access

to a CGM data via personal website, smartwatch

viewers, or apps and widgets available for

smartphones

www.nightscout.info

Nightscout

SummaryMore and more products are being developed that will:

Reduce the burden for patients with diabetes

What should I eat?

What is my sugar?

How much medicine/insulin do I need?

Simplify data collection and analysis

Improve adherence with reminders and alerts

Connect caregivers and HCPs with patients with diabetes

Improve diabetes control

Reduce the risk and fear of hypoglycemia

Help patients maintain healthy, complication free lives

Questions?

A helpful website to keep abreast of new advances in diabetes

treatment and technology:

diatribe.org