For the nearly 40 million Americans living with diabetes, an important part of managing the disease is monitoring blood sugar throughout the day and night.
But staying on top of this information is challenging, especially for younger patients who may fear the finger pricks required. And other methods that aren't as invasive, such as continuous glucose monitors, still ask users to insert a sensor under the skin and wear a small transmitter whose visibility may make some users uncomfortable.
A new device based on research from Indiana University could one day provide an alternative - or supplement current methods to provide better protection against more serious swings in blood sugar. It might also help individuals at risk for Type 2 diabetes better monitor their blood sugar to reduce their risk of the disease.
A prototype of isaac by PreEvnt, a small lightweight device that can be worn on a lanyard to provide easy and accurate information about blood sugar levels from breath, developed based on research from the Integrated Nanosystems Development Institute at IU Indianapolis. Photo by Liz Kaye, Indiana University
Isaac by PreEvnt, a subsidiary of Scosche Industries, is a small lightweight device that can be worn on a lanyard around the neck to provide easy and accurate information about users' blood sugar using only their breath.
The breathalyzer technology was developed in collaboration with the Integrated Nanosystems Development Institute at IU Indianapolis, and was inspired by diabetes alert dogs. These service animals are trained to detect when their owners experience hypoglycemia, a dangerous condition that can lead to serious complications, including coma, if not treated promptly.
"Our lab was able to successfully identify the specific molecules in breath that correlate with hypoglycemia, which is the 'scent' that diabetic alert dogs can detect," said Mangilal Agarwal, director of the Integrated Nanosystems Development Institute and a professor in the IU Luddy School of Informatics, Computing and Engineering at IU Indianapolis. "In addition to identifying these molecules, our lab is testing nanoscale sensors to detect them, while also collaborating with partners to commercialize the technology."
Diabetes affects abouts 38.4 million people in the United States, or 11.6% of the population, according to the CDC National Diabetes Statistics Report, and an estimated 830 million people worldwide, according to the World Health Organization. The condition is also the most expensive chronic disease, with costs reaching $412.9 billion annually in the U.S., according to the American Diabetes Association.
But early diagnosis can dramatically mitigate the most severe impacts of the disease, such as kidney failure, heart attack, stroke, blindness and lower limb amputation.
Mangilal Agarwal, center, shows the isaac device to INDI lab member Akanksha Tipparti, a Ph.D. student in biomedical engineering at the IU Luddy School in Indianapolis. On the right is Mark Woolam, a senior research scientist at the Integrated Nanosystems Development Institute. Photo by Liz Kaye, Indiana University
Developed by PreEvnt in collaboration with IU, the isaac device uses sensors from the Nanoz Group to detect chemicals in breath that correlate to blood glucose levels. The compounds it detects were identified at IU, and Agarwal's research team is working to qualify the sensor devices in the laboratory.
"This device has the potential to offer real advantages over current monitoring technology," said Agarwal, whose lab is also developing sensors. "Continuous glucose monitors require insertion into the body to measure interstitial fluid and provide insulin, and need frequent replacement. Finger pricking, which must be done multiple times a day, is also invasive and often impractical. Non-invasive monitoring in real time can help mitigate these challenges."
Agarwal's lab is partnering with the IU School of Medicine to test and validate the effectiveness of the device in individuals with diabetes - an important next step on the path to wider commercialization.
The trial will be conducted under the guidance of Dr. Linda DiMeglio, the Edwin Letzter Professor of Pediatrics at the IU School of Medicine. Assessing how accurately the device can monitor blood glucose levels compared to traditional methods will be crucial to understanding the potential benefits for patients, she said.
While the Integrated Nanosystems Development Institute leads engineering and chemistry for the project, "Our group's role is to advise on the clinical aspects - obtaining regulatory approvals, recruiting participants, assisting with data analyses," DiMeglio said. "Depending on the study results, we want to be able to bring this device to the broader market quickly, especially in children.
She also noted that diabetes is an expensive condition due to the cost of insulin and other equipment.
"We see children as young as 1 year old with diabetes in our clinic, which places a real burden on families," she said. "Introducing an affordable, non-invasive device for young children would be incredibly beneficial."
In preliminary work leading up to this trial, Agarwal's lab partnered with a summer camp for children with diabetes led by DiMeglio in Indianapolis. Participants at the camp provided some of the early-phase research data for Agarwal's initial study on the viability of blood sugar breathalyzer technology. More recently, the lab published a new study on the topic in the journal Nature Scientific Reports, focusing on clinical validation of the results from the pilot study.
Members of the Integrated Nanosystems Development Institute, from left: Mark Woollam, senior research scientist; Mangilal Agarwal, director; Eray Schulz, IU School of Science Ph.D. student in chemistry; Akshay Mane, electrical engineer; Dipak Maity, operations manager; Akanksha Tipparti, IU Luddy Ph.D. student in biomedical engineering; and Yeshwant Kasa, IU Luddy MS student in computer science. Photo by Liz Kaye, Indiana University
Although the utility of the breathalyzer as a non-invasive alternative will ultimately depend on its speed and accuracy at measuring blood sugar, DiMeglio said it's most immediate impact may be supplementing existing measurement methods.
For example, the device could potentially be worn at night to alert individuals if their blood sugar drops to dangerously low levels while sleeping. It could also potentially work in concert with a portable insulin pump to calibrate small dosage adjustments throughout the day.
"The clinical trial work will really help us further refine the device for maximum user benefit," said Mark Woolam, a senior research scientist in Agarwal's lab who is assisting with the trial. Nate De Jong, a Ph.D. researcher in DiMeglio's lab, is also coordinating access to the camp and other patients.
"Everything we're working on in our lab, we're working on because we want to solve real-world problems - and the most effective way to get those solutions to people is by taking it to consumers and the market," Agarwal said. "It's our desire to make a tangible impact on people's lives."
