Check out the bionic kids at Camps Clara Barton and Joslin from The Helmsley Trust

An interview with Ed Damiano and the team at BU from InsulinNation

A CALL TO ACTION! Donate Now to The Boston University Bionic Pancreas Project

The CWD Foundation is most grateful for the brilliant work of Ed Damiano and his team at Boston University in their mission to create a bionic pancreas. They are in need of funding to complete the design, construction, testing, and regulatory work for the bionic pancreas. Financing should not be cause for delay. Please read Ed Damiano's message below. By supporting the bionic pancreas development effort, the T1D community itself participates in the self-empowering act of bringing about an historic and profoundly positive transformation in all of our lives.

The Boy Who Lived

Nearly 14 years ago, when he was just 11 months old, my son, David, developed type 1 diabetes (T1D). Had it not been for the discovery and purification of insulin 80 years earlier, David certainly would not have survived past infancy. Thanks to the magic of insulin, David, like so many others, survived that initial encounter with diabetes. However, ever since that fateful day of diagnosis, he carries with him the burden and the risks of self-managed diabetes care every day and every night of his life. Soon after David was diagnosed, I set my sights on building a bihormonal bionic pancreas and making it available to people with T1D by the time David would head off to college in the fall of 2017.

The Bionic Pancreas

My engineering team at Boston University set out to build the bionic pancreas over ten years ago. In deference to millions of years of evolution, our bionic pancreas mimics biology and uses both insulin and glucagon to automatically regulate glycemia in T1D. The system consists of three components: a continuous glucose sensor, an infusion system to pump insulin and glucagon through the skin, and a mathematical algorithm transcribed in software that makes therapeutic decisions every five minutes to determine each dose of insulin and glucagon.

Over the years it has evolved from a crude and clumsy system of interconnected components of pumps and sensors cobbled together around a laptop computer, then to a system that runs on an iPhone that can be carried in your pocket, and finally to its ultimate embodiment as a dual-chamber infusion pump, a sensor, and a mathematical algorithm all housed within a single compact integrated device.

Our bionic pancreas continuously adapts to your everchanging insulin needs automatically, without the need to know your carb-to-insulin ratios, your basal rates, or your correction factors. Newly diagnosed people with T1D would never need to learn these concepts; and those who have lived with T1D will never have to think about them again. Our bionic pancreas asks only for your weight to get to know you, and then it does the rest. It's truly a turnkey solution for people with T1D.

Past Clinical Trials

We began testing early versions of our bionic pancreas in pre-clinical trials in diabetic pigs at Boston University in 2005. In 2006 we began a collaboration with our clinical team at the Massachusetts General Hospital. In 2008 we began our first of three inpatient trials in adults and adolescents with T1D. In 2013 we conducted our first two outpatient trials in adults and adolescents with T1D.
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When tested in real-world outpatient settings, where subjects were free to eat and exercise as much and as often as they wished over five continuous days and nights, the bionic pancreas was able to maintain near-normal blood glucose levels with virtually no hypoglycemia. In 20 adults living in downtown Boston for five days, the mean glucose level was 132 mg/dl (which corresponds to a mean HbA1c of 6.2%) with glucose levels below 60 mg/dl only 1.5% of the time. In 32 adolescents living in a diabetes summer camp for five days, the mean glucose level was 142 mg/dl (which corresponds to a mean HbA1c of 6.6%) with glucose levels below 60 mg/dl only 1.3% of the time. Such safe and effective glycemic control would put an end to all long-term complications of T1D and at the same time eradicate any risk of severe hypoglycemia.

Future Clinical Trials

In 2014 we will conduct two more outpatient trials. One of these will test the bionic pancreas in 24 preadolescents with T1D living in a diabetes summer camp for five days. The other will be our first multi-center trial in which we will test the bionic pancreas in 48 adults with T1D throughout the course of two of their routine work weeks. In the second half of 2015 we are planning to begin our final pivotal trial testing the bionic pancreas in hundreds of people with T1D over the course of several months. This trial will conclude in the second half of 2016.

Building the Bionic Pancreas

Together with our industrial collaborators, we are in the process of building the ultimate embodiment of our bionic pancreas. The dual-chamber infusion pump and the custom dual-cannula infusion set that goes with it, will be completed in the first half of 2015. The bionic pancreas will use insulin lispro and pumpable glucagon. The pharmaceutical company we are collaborating with is already in clinical trials testing their glucagon in people with T1D. The pivotal trial of 2015 and 2016 will provide all of the clinical data necessary to qualify both the bionic pancreas and this pumpable glucagon for FDA review of the drug–device combination product.

The Road Ahead

The bionic pancreas brings us nearer to a practical cure for T1D than anyone thought possible just a few years ago. We are less than 18 months from beginning our final pivotal trial and less than 42 months away from widespread availability in the US. We no longer need to talk in the vagueness of years – now we can talk in terms of months. We have raised all of the funding necessary to conduct the clinical trials of 2014 and and are looking to philanthropic foundations and the NIH to provide the funding necessary for the final pivotal trial of 2015 and 2016. However, we are still in need of funding to complete the design, construction, testing, and regulatory work for the bionic pancreas. To avoid delay, this work needs to be completed before the third quarter of 2015. Financing should not be cause for delay.

A Call to Action

We look to the T1D community to provide the remaining financial resources needed to build the bionic pancreas. By supporting the bionic pancreas development effort, the T1D community itself participates in the self-empowering act of bringing about an historic and profoundly positive transformation in all of our lives. We must commit not only to raising the funds necessary to build the device, but to protect it, in perpetuity, from any and all forces that would seek to usurp our rightful access to the best medical technologies the modern world has to offer. We build the bionic pancreas, we own it, we protect it, and in return it will take care of us, our children, and our families for as long as should be necessary, until a more elegant biological solution can be found.


Make a Donation to The CWDF Bionic Pancreas Fund
make a donation
Any donation made to the CWDF Bionic Pancreas Fund will be given 100% to the Bionic Pancreas project and is tax deductible. Our staff is made up of volunteers and have no overhead charges.


Make a donation directly to Boston University
donateToBU
Boston University assesses no overhead charges to your tax-deductable donation, so all funds pass though in their entirety to a dedicated account that is used exclusively to support the development of the Boston University Bionic Pancreas


 

 

Donate to the CWDF Bionic Pancreas Fund
donation
Any donation made to the CWDF Bionic Pancreas Fund will be given 100% to the Bionic Pancreas Project and is tax deductible. Our staff is made up of volunteers and have no overhead charges.

 

 

 

David


bionic pancreas

Make a donation directly to Boston UniversitydonateToBU
Boston University assesses no overhead charges to your tax-deductable donation, so all funds pass though in their entirety to a dedicated account that is used exclusively to support the development of the Boston University Bionic Pancreas

 


Copyright © 2008 Children With Diabetes Foundation