@DanaMLewis | #OpenAPS | #WeAreNotWaiting | · Cruise control makes it easier to drive your target speed. @DanaMLewis. ... An artificial pancreas is the closest thing to “cruise

Vermont Health Information Exchange SummitNavigating the Health IT Landscape

Closing the loop:#WeAreNotWaiting to change the future of healthcare

@DanaMLewis | #OpenAPS | #WeAreNotWaiting |

www.OpenAPS.org


Getting diagnosed with a chronic disease is like being struck by

lightning.

@DanaMLewis


Food, hormones, sickness, stress

Insulin, exercise, sickness, stress

@DanaMLewis


Cruise control makes it easier to drive your target speed.

@DanaMLewis


An artificial pancreas is the closest thing to “cruise control” for diabetes.

@DanaMLewis


…But an artificial pancreas is not yet commercially available.

@DanaMLewis


The current tools are not perfect….

Insulin Pump

@DanaMLewis


Insulin is the “gas” pedal.

@DanaMLewis


….and there are other tools but they are not interoperable.

Continuous Glucose Monitor (CGM) Insulin Pump

@DanaMLewis


This all leaves people frustrated and at risk, every day and every night.

@DanaMLewis


Data access is also a struggle.

@DanaMLewis


If we can’t change existing devices…

what if we could add *new* tools?

@DanaMLewis


Tackling the problem of less-audible alarms:

@DanaMLewis


Tackling the problem of less-audible alarms:

1. Get data from device with open source code2. Display data & generate louder alarms3. Share data with loved ones4. Add “snooze” buttons5. Enter specific actions/more buttons6. Create forecast (algorithm) with data sources7. Add additional “smart” alarms with action

recommendations

@DanaMLewis


From reactive to predictive: an “open loop”

@DanaMLewis


What happens if we “close the loop”?

@DanaMLewis


We already have in our pockets the tools

needed for an “artificial pancreas”.

@DanaMLewis


Components of an open source artificial pancreas

(Illustration by Clint Ford for Popular Science)

1. Continuous glucose monitor

2. Insulin pump

@DanaMLewis


Components of an open source artificial pancreas

(Illustration by Clint Ford for Popular Science)

1. Continuous glucose monitor 2. Raspberry Pi (“controller”)3. Battery4. CareLink USB stick (“translator”)5. Insulin pump

@DanaMLewis


Life with a DIY Closed Loop

@DanaMLewis


(It’s not “rocket science”)

@DanaMLewis


What about regulations?

• Most users “test” their traditional medical devices, too.

• Individual experiments with “off label” use of medical devices are not a regulated activity in the U.S. – and so while we can’t (per the U.S. FDA) “distribute” devices, people can self-experiment with their own.

• The self-QA approach is even stronger when utilizing open source tools made with/by/for the community.

@DanaMLewis


Taking the DIY, artificial pancreas from (n=1) to (n=1)*many by:

• Focusing on safety

• Limiting dosing ability in hardware and software

• Using same dosing calculations a person would use

• Responding (or not) to unexpected data

• Tolerating communication failures

• Failing back safely to standard device operation

#OpenAPS:

@DanaMLewis


Documentation

Code

Reference Design

OpenAPS.org Github.com/openaps

@DanaMLewis


#OpenAPS is now (n=1)*112+

@DanaMLewis


The challenges of traditional regulation:

• Individuals are inadvertently being pressured to not share their innovations (!) for fear of retribution and regulations.

• There need to be more opportunities for individuals, academic research, and commercial innovation efforts to intersect.

• Companies should not be held liable by 3rd

parties (including patients themselves!) innovating or adapting technology – and need to be explicitly encouraged to allow access to data. @DanaMLewis


Traditional innovation

User-driven innovation

@DanaMLewis


Traditional innovation

User-driven innovation

@DanaMLewis


#WeAreNotWaitingto change the future of healthcare.

Are you?

#OpenAPS | @DanaMLewis | OpenAPS.org

Documents

@DanaMLewis | #OpenAPS | #WeAreNotWaiting | · Cruise control makes it easier to drive your target speed. @DanaMLewis. ... An artificial pancreas is the closest thing to “cruise