2016-07-07 howard look nih-niddk artificial pancreas workshop
TRANSCRIPT
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Howard Look Founder and CEO
NIH-NIDDK Fourth Artificial Pancreas Workshop July 7, 2016
Bethesda, Maryland
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Disclosure I own publicly traded stock in Dexcom (DXCM)
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Motivation
Katie Look First Day of 6th Grade, 2011
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Type 1 Diabetes is a really, really sucky disease.
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c X
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Proudly non-profit. Open source.
Stewards of your data.
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TidepoolUploader
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Coming soon Coming soon
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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
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When you liberate data, you enable a vibrant ecosystem
of applications and research.
earthables.com
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Nutshell MySugr Engine1 Glooko
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nightscout.infodexcom.com
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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
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What does a vibrantArtificial Pancreas Ecosystem
look like?
earthables.com
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Artificial Pancreas Telemetry Dashboard
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What if the Artificial Pancreas Ecosystem were based on interoperable components?
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Sensor
Algorithm
Pump
Helper Apps
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Sensor
Algorithm
Pump
Helper Apps
Dexcom G4 / G5 / G6 / … Medtronic Enlight 1 / 2 / 3 / … Abbott CGM NewCo CGM …
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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
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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
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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
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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
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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
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But… how?
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Authentication Capabilities
Commands and Data Encryption
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Sensor Pump
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Sensor Pump
“Hi, I’m a sensor. I’d like to send you data.”
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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.”
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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.”
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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.”
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Sensor Pump
“I’m ready to send you data.”
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Sensor Pump
“I’m ready to send you data.”
“Hold on there cowboy. What capabilities do you have?”
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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”
}
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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.
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Perceived challenges to an Artificial Pancreas Ecosystem:
It’s hard. I’m scared.
It’s extra work. They won’t let me.
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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.)
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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.)
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(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.
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Myth:
It’s extra work and will slow us down!
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Myth:
It’s extra work and will slow us down!
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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.)
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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.)
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Myth:
Regulators will never allow it. We’ll never get support for it.
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Myth:
Regulators will never allow it. We’ll never get support for it.
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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.
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www.theodysseyonline.com
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whitehouse.gov @danalewis gettyimages.com
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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
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Why DIY Matters. (Hint: It’s not about the car…)
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OpenAPS.org
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“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
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wallpaperswide.com
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Type 1 Diabetes is a really, really sucky disease.
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whosthebeaver.com/?m=200807
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The DIY movement is the leading edge of the
Artificial Pancreas Ecosystem.
earthables.com
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@loudnate@jasoncalabrese @AliMazaheri
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The DIY Movement: Empowered patients. Driving innovation.
Taking control of their own care.
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“The Innovation Wetlands” Andrew Torrance and Eric von Hippel
www.rhodeislandpropertylaw.com
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whosthebeaver.com/?m=200807
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“It’s not about the car. It’s about the drive.”
- Mark Wilson @warkmilson shutterstock.com
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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.
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The Horace W. Goldsmith Foundationand Hundreds of Other Donors
Thank you!