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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.
Tidepool

Uploader
Coming soon Coming soon
Production
Environment
Amazon Web ServicesPublic Internet
Staging

Environment
Production
Environment
Staging

Environment
Development

Environment
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 Calculator
Research Apps
and Interfaces
Remote Monitoring
Apps 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
Supply

Management
T1D Triathlete

Trainer
T1D

Telemedicine
What does a vibrant

Artificial 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 and

how 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 Foundation
and Hundreds of Other Donors
Thank you!
tidepool.org
@Tidepool_org
howard@tidepool.org
@HowardLook

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2016-07-07 Howard Look NIH-NIDDK Artificial Pancreas Workshop