“Mommy, wouldn’t it be cool if a kid discovered a cure for diabetes as a science fair project?”
My then 11 year old daughter, Kate, said those very words to me as she was working on her own science fair project in the winter of 2012. Only a little more than a year into the Type 1 diabetes journey at that point, my eyes filled with tears. But I took a deep breath and agreed. Then I suggested she come up with a project to raise awareness. That project led us on an incredible journey. Through Kate’s research, she learned that artificial pancreas (AP) clinical trials were underway and asked if she could submit her name.
“Sure,” I said.
In July 2012, we applied to be part of the University of Virginia’s AP Project. And then we waited.
In July 2013, we got the call. Could we be at UVA in two weeks? Oh, yeah, we could. And we were.
The AP system uses micro boluses of fast acting insulin that continually change in response to the readings from a continuous glucose monitor (cgm). No glucagon is used with this AP. The purpose of the trial we participated in was to create a common set of situations among teens with Type 1 diabetes like underbolusing for meals and forgetting to bolus. The group consisted of sixteen teens between ages 13-17 with an average of seven years with Type 1 diabetes.
And the results?
Those tiny adjustments throughout the day improved blood glucose control WITHOUT causing lows– and no need for glucagon. This was the first evidence of an AP system improving blood glucose levels following insulin omission for carb intake among teens. (The age group that is notorious for “forgetting” to bolus.)
In the focus group follow up all of the teens said they wanted this device and they wanted it yesterday. As for me? Watching that computer screen and being able to see the insulin amounts change was amazing. Watching Kate’s blood glucose react to those changes was beyond amazing. And like Kate and the rest of her fellow participants, I want it. Now. We aren’t alone in that desire. The team behind this amazing technology is driven to getting this in our hands–sooner, rather than later.
UVA has partnered with facilities around the world from Stanford and UCSB to Europe and Israel, and talks are in the works with a site in Buenos Aires, Argentina. According to Dr. Daniel Chernavvsky, Assistant Professor of Research at the UVA Center for Diabetes Technology, a multi-center adult trial, AP@Home, will be completed here in the U.S. within the next couple of months. The European AP@Home is still underway. In addition to these trials and one like Kate did, trials for younger children will soon be starting at summer camps in France and Italy.
We are excited to learn that based on the ten years of clinical trials at UVA, a new startup, Type Zero, is taking the inControl Diabetes Management Platform– which is the software running the UVA AP — to the next level. The TypeZero staff is comprised of a number of the UVA AP team, including chief mathematician, Dr. Boris Kovatchev, and head of patient engagement and a Type 1 herself, Molly McElwee-Malloy.
According to Dr. Kovatchev, a large-scale study is to begin next year and serve as the definitive trial intended to establish closed-loop (AP) control as a viable treatment for Type 1 diabetes. Molly McElwee-Malloy adds that TypeZero is working “to ensure that our diabetes management technology works seamlessly with all devices currently available in the market in order to provide end-users the choice to select the devices they desire based on their very own lifestyle.” She looks forward to building partnerships with the current device makers towards a goal of “standardization of data management standards” within the industry. McElwee-Malloy explains that their technology will allow existing pump/cgm devices to submit blood sugar data to the TypeZero cloud, where it will be analyzed and adjustments to insulin dosing will be made. Users will have to the choice to use those recommendations for a complete closed-loop AP, or for overnight only closed-loop, or for recommendations for manual basal and bolus dosages. TypeZero’s goal for submission to the FDA is 2017.
There is still work to be done, and you can be part of making history. If you are interested in participating in artificial pancreas clinical trials at UVA’s Center for Diabetes Technology email them at firstname.lastname@example.org.