road to the artificial pancreas (2014 update)

Road to the Artificial Pancreas

Kevin McMahonCEO & Founder - Diabetech, LP

Advanced Diabetes Management RetreatTexas Lions Camp - Kerrville, Texas - April 26, 2014

Copyright © Diabetech, LP 2014. All rights reserved worldwide.

?

According to the JDRF:“An artificial pancreas will integrate two currently available technologies -- continuous glucose monitors and insulin pumps -- with a software that provides the right amount of insulin at the right time. It will enable people with diabetes to achieve tight blood glucose control avoiding both highs and dangerous lows, thereby significantly reducing the risk of the disease's devastating complications.”Source: http://artificialpancreasproject.com/about/algorithm.html

My observation: JDRF AP website last updated 2012 including several broken links when visited in April 2014.

What is the AP?:

AP Trial Sites:

USA based AP Trial Sites:

It works!!!Well, kind of…

Just like a Meter = CGM(if you’re willing to poke your finger and check blood sugar every 5 minutes)

Current Status of the AP:

A. In a very small number of well controlled trialsB. Only under supervisionC. In a controlled settingD. For well screened patients with good skillsE. For short duration not more than a few daysF. 10s if not 100s of millions $ already investedG. Always looking for more $H. Nobody can say when it will be approvedI. Once approved, nobody can say when it will be availableJ. Nobody knows how much it will costK. Nobody knows what your cost will be (e.g. Insurance)

Status of the AP:

An artificial pancreas will integrate many current and yet to be developed technologies:1. in-body, on-body and near body sensors.2. mechanized dosing machines.3. drugs to affect regulation and counter-regulation of blood sugar4. software that provides the right amount of dosing & instruction at the right time. 5. communications for remote command and control

It will enable people with diabetes to achieve improved blood glucose control experiencing significantly fewer highs and lows including shorter duration. In addition to significantly reducing the risk of the disease's devastating complications, patients and their families will also enjoy a much improved quality of life while simultaneously reducing the overall cost of care.

Source: Patent applications and grant proposals submitted by Kevin McMahon & Diabetech since 2002.

My View on the AP?:

Copyright © Diabetech, LP 2014. All rights reserved worldwide.

In 2005, according to Aaron Kowalski, JDRF AP Director:

“There is no need for remote monitoring in the development of the Artificial Pancreas. Furthermore, there is no business model to commercialize this feature.”Source: breakfast meeting in Dallas, Texas between A. Kowalski and K. McMahon

Remote Command & Control:

Perspectives Change:

AP Goes Mobile2011 JDRF Funds Pilot SystemPrior to this study, artificial pancreas tests had employed laptops wired to continuous glucose monitors and insulin pumps. The paper called the old AP “a system limiting free movement and too cumbersome to be used beyond hospital confines.” - Boris Kovatchev, UVA researcher

Source: http://j.mp/mhealthnewsAP; a story by Neil Versel based on clinical trials published in Diabetes Care.

Inputs ----> Magic ---> Outputs

My AP Equation:

Staticpatient profile (age, weight, etc…)type of insulin (ie - u100 vs u400)ratios (I:C, ISF, etc…)time of day ratiosanything you program today

Dynamiccommand machines to startblood sugar level (bgl)rate of change in bglnutrition (consumed vs. served)insulin on boardglucagon on board (* new)command machines to stopanything you can observe today

Two Kinds of Inputs:

StaticI don’t think there are any

Dynamiccommand the pump(s) to dosecommand the pump(s) to stopquery the sensor(s)assess quality of machinerymanage time and synchronizetell the patient to do somethingnotify a remote caregiver

Outputs are Dynamic:

Devices, Software and Computer Networks that consider inputs and generate outputs based in their inherent limitations.

The military refers to this as C4 : command, control, communications and computers.

When they add the human element they add an i; C4i

Magic is:

Never underestimate the power of “i”

Inputs ----> Magic ---> Outputs

My AP Equation:

repeat

Inputs ----> Magic ---> Outputs

My AP Equation:

repeat

predict

Inputs ----> Magic ---> Outputs

My AP Equation:

repeat

predict

compare

Inputs ----> Magic ---> Outputs

My AP Equation:

repeat

predict

compare

suggest

Situational Awareness Assisted by C4:● ambient sensors to remind us that it’s hot out (temperature)● bio sensors to suggest a basal change (activity)● interfaces that communicate situation to the user better than today’s

screens (glance-ables, beeps, blips and buzzes)● personalized feedback to address uniqueness (rewards)● life-like simulators for educational purposes

C4 (definition): commonly used in the military as an abbreviation for Command, Control, Communications, and Computers to assist in combat situations.

Rest Stops On The Road to AP:

Copyright © Diabetech, LP 2014. All rights reserved worldwide.

Make Something:

DexWatchDon Browne, engineer w/t1

“The interface for a CGM should be a watch; not something shoved in your pocket.”

The key is that it should be something you can easily glance at vs. hidden away.

1. Write a check2. Get others to write checks3. Register for participation in a future trial:

(http://j.mp/clinicaltrials-gov-apSearch)4. Learn how to get the most out of what you have available to you today5. Practice what you’ve learned every day6. Make something7. Share your knowledge8. Support innovation and each other

Eight things you can do: