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September 22, 2017

Following the lead of a patient researcher who created an artificial pancreas, ASU team is helping to transform diabetes care

The problem was simple but serious. Dana Lewis has type 1 diabetes and is a heavy sleeper, and the alarm on her continuous glucose monitoring (CGM) device that let her know her glucose levels were dangerously low wasn’t loud enough to wake her up at night.

On nights when this happened, she awoke the next day feeling exhausted. It also added to her worry that one day she might not wake up.

For those living with type 1 diabetes, maintaining steady glucose levels at all hours of the day is critical, and doing so while sleeping can be particularly challenging, even life-threatening.

After searching unsuccessfully for devices with a louder alarm, Lewis set out to solve the problem herself. Learning everything she could about her CGM device, she developed a hack that allowed her to turn up the alarm volume and rest easier at night.

But the Seattle woman didn’t stop there. Dissatisfied with the type 1 diabetes treatment options on the market, Lewis sought out her own solutions. Along with her now husband Scott Leibrand, in 2013 she developed a predictive algorithm that forecasts her glucose levels throughout the day and creates personalized recommendations for needed actions.

A year later, using off-the-shelf hardware and additional open-source code, she became one of the first people in the world to build a hybrid closed-loop artificial pancreasThe Artificial Pancreas System (APS) is designed to automatically adjust an insulin pump’s basal insulin delivery to keep blood glucose in a safe range overnight and between meals. It does this by communicating with an insulin pump to obtain details of all recent insulin dosing (basal and boluses), by communicating with a Continuous Glucose Monitor to obtain current and recent blood glucose estimates, and by issuing commands to the insulin pump to adjust temporary basal rates as needed. to automate adjustments of insulin delivery, a long-sought-after advancement among people with type 1 diabetes, and one that wouldn’t become commercially available until mid-2017. She explains that her system, which is now open-source, continues to offer greater flexibility and customizations than the technology currently available on the market.

diabetes, glucose, openAPS
Dana Lewis, patient researcher, displays her open-source artificial pancreas system.

Today, Lewis is using this experience to improve the lives of those living with type 1 diabetes by sharing her story and techniques through the online community she founded, OpenAPS.org. By doing so, she is challenging the notion of what it means to be a professional scientist.

Lewis’ work is being supported by a nearly half-million-dollar grant from the Robert Wood Johnson Foundation, administered through the ASU Foundation. She’s working with co-principle investigators Eric Hekler, associate professor in the School of Nutrition and Health Promotion, College of Health Solutions, and Erik Johnston, associate professor in the School for the Future of Innovation in Society and director of policy informatics at the Decision Theater. Along with Keren Hirsch, business operations specialist with the Tempe Decision Theater, postdoctoral fellow John Harlow and doctorate student Sayali Phatak, the team will explore the potential of citizen scientists like Lewis to disrupt traditional scientific research and give patients the tools they need to better manage their health care.

Hekler first met Lewis in 2016 when she presented at a conference he was attending. Inspired by her work and message, he felt compelled to support her efforts, bringing Johnston into the discussions.

“We are called to be responsible for the economic, social, cultural and overall health of the communities we are a part of,” Johnston said. “Waiting for expertise to arrive fails vulnerable populations. Dana is demonstrating, and we will affirm through this work, that expertise is not just credentialed expertise. This was ASU’s charter in action.”

Hekler hopes to determine how expanding patient-led, use-inspired scientific research and data collection can inform real-world problem-solving.

“Dana is the type of person we need to reinvigorate the population to be engaged in questions of science and how common people can find solutions,” Hekler said.

“There is an inherent power hierarchy in health care that puts patients between a rock and a hard place,” Lewis said. “Patients are expected to be compliant with the doctor’s orders, but also engaged and empowered to drive their own care. Through this grant, we hope to begin dismantling this hierarchy and provide new pathways for patient-led research.”

It’s a different way of looking at science and medicine, one the team rightly acknowledges.

A communications professional by trade, Lewis doesn’t possess a traditional technical, engineering or medical background. The self-taught scientist is defying the customary model for science education, research and discovery, using her experience as a patient to inform her work.

“Living with type 1 diabetes has given me an acute understanding of my body, what it needs and how it reacts to changes,” Lewis said. “Patients living with a chronic illness have invaluable experiences that can inform our understanding of the disease and the development of personalized treatment options.”

Over the course of the 18-month grant, the team will explore strategies for supporting patient-led research. An on-call data science team will collaborate with patients to answer questions from people with type 1 diabetes seeking to improve their knowledge of diabetes management. An open data repository will store patients’ donated glucose-monitoring information in support of community-based research and discovery. The team will scale the work to other patient communities through the creation of protocols and training materials, with the goal of reducing the distance between knowledge discovery and use.

In spite of the team’s enthusiasm, the patient-as-scientist model is not without its critics.

“Patient-led research is often not taken seriously or respected by the academic and medical establishment due to it being driven by ‘non-professionals,’” Lewis said.

The model raises questions about the safety of self-experimentation, the reliability of data and the validity of research findings. The team will explore these very topics as part of the grant, as well as the barriers to patient-led research and stigmas associated with it.

To date, more than 400 people around the world have used Lewis’ research and experiences to develop personalized closed-loop systems, including Leo Koch, an 11-year-old in Waterville, Maine, who has been successfully managing his type 1 diabetes for the last year using his own closed-loop system.

“It’s been life-changing for us,” said Leo’s mother, Hilary Koch. “It’s been life-saving. If we could scream about it from the rooftops, we would.”

Leo’s mother is a vocal advocate for Lewis’ work and the system that changed her son’s life.

“The industry wasn’t moving as fast as it should have been,” Koch said. “We are not waitingThe OpenAPS global community, led by Lewis, uses the hashtag #WeAreNotWaiting to express their desire for more type 1 diabetes solutions that reduce the burden of care. The group supports each other by answering questions and sharing information. to keep our kids, loved ones, brothers and sisters safe.” Since her son began using the closed-loop system, his outlook has dramatically improved. “He will always be type 1, but it is so under control that a doctor wouldn’t diagnose him with type 1 diabetes looking solely at his glucose levels.”

And although Lewis’ system would seem primed for the commercial market, drawing attention from the U.S Food and Drug Administration, her intentions are more altruistic.

It’s her commitment to helping others living with type 1 diabetes that makes this project so unique, said Hekler.

“She isn’t doing this to try and get rich quick; she’s doing it to help other people live healthier, happier, safer lives,” Hekler said.

Lewis hopes that the development of information-sharing systems for patients in the diabetes community and beyond will allow greater collaboration among patient scientists and encourage non-traditional thinking about health-care innovation and discovery.

For Lewis, the grant is validation of her years’ worth of work.

“The fact that both ASU, with its reputation for innovation, and the Robert Wood Johnson Foundation have both said, ‘This work matters,’ means everything,” Lewis said. “It’s incredibly rewarding.”

 
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ASU profs receive $2M to study impact of salad bars on kids' fruit, veggies consumption

CDC: 93% of kids don’t eat enough veggies, and 60% don't eat enough fruit.
Not enough fruits and veggies can lead to heart disease, cancer or diabetes.
September 22, 2017

Study involving 36 schools throughout Arizona will build on duo's previous research

Adam Sandler’s satirical 1993 ode to that most crucial fixture of school cafeterias, the lunch lady — played to hilarious perfection by a hair-netted Chris Farley in his prime — did a splendid job of reminding us all of the less-than-savory offerings of our youthful noontime repast.

“Hoagies and grinders, hoagies and grinders / Navy beans, navy beans, navy beans,” Sandler sang with nostalgia.

But chances are, nobody was actually eating those navy beans. Healthy food isn't always at the top of kids' minds.

The Centers for Disease Control and Prevention estimates that 93 percent of children don’t eat enough vegetables, and 60 percent of children don’t eat enough fruit to meet daily recommendations. That should be alarming to many, as a diet insufficient in fresh produce can lead to serious health complications later in life, such as cardiovascular disease, various cancers and type 2 diabetes, said Marc Adams, Arizona State University assistant professor of exercise science and health promotion.

“It’s important to provide opportunities for kids to develop healthy behaviors and eating habits early in life,” he said, “so they can persist throughout the lifespan to prevent [those kinds of diseases].”

Adams and Meg Bruening, fellow School of Nutrition and Health Promotion assistant professor of nutrition, just received a $2 million grant from the National Heart, Lung and Blood Institute to conduct a four-year study on the efficacy of salad bars in school lunchrooms.

“There are 31 million kids that participate in the national school lunch program, and if we can find ways to increase their fruits and vegetables that are effective, we need to be promoting those, and salad bars are one of the most heavily promoted ways of doing that — but we don’t know if they work,” Bruening said.

“Schools are investing a lot of money in this without much evidence, so we’re trying to provide a total picture of the evidence.”

The study will build on the duo’s previous research, published in 2016, which found that placing salad bars inside the lunch line in cafeterias, as opposed to outside of the line, resulted in four to five times higher consumption of fresh fruit and vegetables.

This latest study will involve 36 schools throughout Arizona. Each year for the first three years, Adams and Bruening will collect data from 12 schools: four elementary schools, four middle schools and four high schools. The final year will be used to sort and analyze the data.

They expect to see a difference in consumption based on age level, Bruening said, because previous research has shown that as children get older, they consume less fresh produce.

Each year of the study, the researchers and their team of roughly 30 ASU undergrads — from a variety of academic backgrounds, including nutrition, public health and medical studies — will measure fruit and vegetable consumption at the schools from the beginning of the school year in August to the end of the school year in May or June.

Within each age level (elementary, middle and high school), the four schools will be randomly selected to receive: no intervention at all; just a salad bar; just marketing materials to promote fruit and vegetable consumption; or both a salad bar and marketing materials.

Adams, Bruening and their research team will visit the schools three times throughout the course of the school year, once before the salad bar is installed, a second time four to six weeks after the salad bar has been installed, and a final time 10-plus weeks after it has been installed.

They will randomly select 100 students from each school and weigh their food trays immediately after exiting the lunch line with full trays of food, then again once the student has finished eating. Fruit and vegetables will be weighed separately from other foods to determine how much of them were consumed, as well as how much went to waste.

Similar studies have asked students how much they ate or otherwise estimated the figure, which is much less accurate than weighing the food trays, Adams said.

They hope to answer a few questions: How does simply providing a school lunchroom with a salad bar, in addition to existing federally mandated portions of fruit and vegetables, affect consumption of fresh fruits and vegetables? How do promotional marketing materials affect consumption of fresh fruit and vegetables? And how do both factors together affect consumption of fresh fruit and vegetables?

They’ll also be looking at cost, and whether a salad bar is economically logical for schools based on how it affects fresh produce consumption.

“We want to understand the whole picture behind having a salad bar,” Bruening said. “Are there cost differences in providing fruits and vegetables in a salad bar compared to fixed portions?”

It’ll be a while before they have definitive results, but they suspect salad bars will have a positive effect for a number of reasons.

“With salad bars, kids can pick what they like and select as much as they like,” Adams said. “That’s different than providing kids with fixed choices and fixed amounts that are pre-portioned, or even pre-plated.”

In previous research, Adams found that the more variety kids were offered, the more they ended up selecting and consuming.

“So salad bars are one way to offer increased variety,” he said.

Still, they want to make sure they’re providing evidence both for whether salad bars actually work, and if so, what are best practices.

Adams and Bruening are still looking for schools to participate in the study. Schools will receive a free salad bar, free high-quality marketing materials, general support from their research team, and a feedback report at the end of the year showing how much was consumed and wasted. They can be reached at Marc.Adams@asu.edu and Meg.Bruening@asu.edu.