2016-07-07 howard look nih-niddk artificial pancreas workshop

Howard Look Founder and CEO

NIH-NIDDK Fourth Artificial Pancreas Workshop July 7, 2016

Bethesda, Maryland

Disclosure I own publicly traded stock in Dexcom (DXCM)

Motivation

Katie Look First Day of 6th Grade, 2011

Type 1 Diabetes is a really, really sucky disease.

c X

Proudly non-profit. Open source.

Stewards of your data.

TidepoolUploader

Coming soon Coming soon

Production Environment

Amazon Web ServicesPublic Internet

StagingEnvironmentProduction

EnvironmentStaging

EnvironmentDevelopmentEnvironment

MongoDB Master

MongoDB Slave

MongoDB Slave

S3 Backup MongoDB Master

Production DB Cluster

Staging/Dev DB

When you liberate data, you enable a vibrant ecosystem

of applications and research.

earthables.com

Nutshell MySugr Engine1 Glooko

nightscout.infodexcom.com

A Vibrant Ecosystem Type 1 Diabetes Application

T1D + Fitness Data Bolus Calculators

Research Apps and Interfaces

Remote MonitoringApps for Pregnant

Moms with T1D

Apps for Teens

Clinical Decision Support

Apps for Kids

Location-aware Apps

Contextual Meal Memory

Psycho-social Research

Artificial PancreasApps for Elderly

SupplyManagement

T1D TriathleteTrainer

T1DTelemedicine

What does a vibrantArtificial Pancreas Ecosystem

look like?

earthables.com

Artificial Pancreas Telemetry Dashboard

What if the Artificial Pancreas Ecosystem were based on interoperable components?

Sensor

Algorithm

Pump

Helper Apps

Sensor

Algorithm

Pump

Helper Apps

Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …

Sensor

Algorithm

Pump

Helper Apps

Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …

Single Reservoir Dual Reservoir Patch Pump Waterproof

Large Reservoir Small Reservoir Shockproof Disposable

Sensor

Algorithm

Pump

Helper Apps

Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …

Single Reservoir Dual Reservoir Patch Pump Waterproof

T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D

Large Reservoir Small Reservoir Shockproof Disposable

Sensor

Algorithm

Pump

Helper Apps

Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …

Single Reservoir Dual Reservoir Patch Pump Waterproof

T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D

Remote Monitoring Research 1 … N Athlete Training Pump Control Telemedicine …

Large Reservoir Small Reservoir Shockproof Disposable

Sensor

Algorithm

Pump

Helper Apps

Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …

Single Reservoir Dual Reservoir Patch Pump Waterproof

T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D

Remote Monitoring Research 1 … N Athlete Training Pump Control Telemedicine …

Large Reservoir Small Reservoir Shockproof Disposable

Sensor

Algorithm

Pump

Helper Apps

Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …

Single Reservoir Dual Reservoir Patch Pump Waterproof

T1D Adult T1D Honeymoon T1D Pregnant Mom T1D Athlete T1D Toddler T1D Teen T2D

Remote Monitoring Research 1 … N Athlete Training Pump Control Telemedicine …

Large Reservoir Small Reservoir Shockproof Disposable

But… how?

Authentication Capabilities

Commands and Data Encryption

Sensor Pump

Sensor Pump

“Hi, I’m a sensor. I’d like to send you data.”

Sensor Pump

“Hi, I’m a sensor. I’d like to send you data.”

“Enter your sensor code so I know it’s really you.”

Sensor Pump

“Hi, I’m a sensor. I’d like to send you data.”

“Enter your sensor code so I know it’s really you.”

“Here a public key you can use to encrypt your data.”

Sensor Pump

“Hi, I’m a sensor. I’d like to send you data.”

“Enter your sensor code so I know it’s really you.”

“Here a public key you can use to encrypt your data.”

“Here’s data, encrypted with that public key you gave me.”

Sensor Pump

“I’m ready to send you data.”

Sensor Pump

“I’m ready to send you data.”

“Hold on there cowboy. What capabilities do you have?”

Sensor Pump

“I’m ready to send you data.”

“Hold on there cowboy. What capabilities do you have?”{

“MARD” : .095“SampleTime” : 300,“TimeUnits” : “seconds”, “MaxLatency” : 750,“Value” : “egv”,“Units” : “mg/dL”

}

By exposing data and control protocols…

We enable interoperability. We catalyze an ecosystem.

We foster innovation. We get products to market faster.

We help more people, more quickly, safely and effectively.

Perceived challenges to an Artificial Pancreas Ecosystem:

It’s hard. I’m scared.

It’s extra work. They won’t let me.

Myth:

If we expose data or control protocols, people might do bad things.

(People might do stupid things and blame us.) (My competitors might misuse the data.)

(I might get sued.)

Myth:

If we expose data or control protocols, people might do bad things.

(People might do stupid things and blame us.) (My competitors might misuse the data.)

(I might get sued.)

(If you are really worried)

Enable the “Ecosystem Switch”

Do you want to enable external remote device control?

ONOFF

WARNING: This device is not intended for use with products that have not been FDA-approved for use

with this device.

Myth:

It’s extra work and will slow us down!

Myth:

It’s extra work and will slow us down!

Myth:

Opening protocols is a security vulnerability and will allow hackers to remotely control

devices.

(I should wait until my protocols are more secure.) (I should wait until there are standards.)

Myth:

Opening protocols is a security vulnerability and will allow hackers to remotely control

devices.

(I should wait until my protocols are more secure.) (I should wait until there are standards.)

Myth:

Regulators will never allow it. We’ll never get support for it.

Myth:

Regulators will never allow it. We’ll never get support for it.

Code of Federal Regulations (CFR)

= Guidance Documents

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.

www.theodysseyonline.com

whitehouse.gov @danalewis gettyimages.com

Executive Order 13563 Improving Regulation and Regulatory Review

“Each agency shall also seek to identify, as appropriate, means to achieve regulatory goals

that are designed to promote innovation.”

– President Barack Obama January 18, 2011

Why DIY Matters. (Hint: It’s not about the car…)

OpenAPS.org

“I woke up one morning, and I was like,

‘How do I feel today?What’s my day going to be like?’

instead of,

‘What’s my blood sugar andhow can I correct that?’ “

— Sara Krugman

wallpaperswide.com

Type 1 Diabetes is a really, really sucky disease.

whosthebeaver.com/?m=200807

The DIY movement is the leading edge of the

Artificial Pancreas Ecosystem.

earthables.com

@loudnate@jasoncalabrese @AliMazaheri

The DIY Movement: Empowered patients. Driving innovation.

Taking control of their own care.

“The Innovation Wetlands” Andrew Torrance and Eric von Hippel

www.rhodeislandpropertylaw.com

whosthebeaver.com/?m=200807

“It’s not about the car. It’s about the drive.”

- Mark Wilson @warkmilson shutterstock.com

1. Open data and control protocols. 2. Embrace and encourage the DIY movement. 3. Watch the ecosystem flourish and

interoperability happen. 4. Deliver safer and more effective products,

more quickly, to more people.

The Horace W. Goldsmith Foundationand Hundreds of Other Donors

Thank you!

tidepool.org @Tidepool_org

howard@tidepool.org @HowardLook