CLEMSON — What started as a Clemson University research project is turning into a global business that could supply diabetics with the low-cost testing equipment they need to manage their blood sugar.

The product, GlucoSense, is aimed at helping diabetics in developing countries and other “resource-poor settings” do the daily testing that can help them prevent potentially fatal complications.IMG_9343

The student-led GlucoSense team has started a company, Accessible Diagnostics, with doctoral student Kayla Gainey serving as chief technology officer.

Greenville businessmen John Warner and Brian McSharry are also co-founders and are serving as executive leadership during the start-up phase. The company has a commitment of $500,000 in private investment from Concepts to Companies, also run by Warner and McSharry.

Delphine Dean, who is also a co-founder, is the company’s technology adviser and Clemson’s Gregg-Graniteville Associate Professor of Bioengineering.

With four awards to its credit, GlucoSense is launching with wind in its sails.

“Most of the research is done,” Gainey said. “We still need to do some final design changes to get to our final product. We’re hoping by the end of the next year that it could be ready to sell.”

Accessible Diagnostics is working with Clemson University Research Foundation to license intellectual property related to the product.

GlucoSense works much the same as glucometers and test strips that can be bought in any pharmacy. Diabetics prick their finger, dab blood on a strip and then insert it into the glucometer to test their blood sugar.

A key difference is that GlucoSense is made from readily available parts that can be found in any U.S. electronics store or bought in bulk and shipped to remote parts of the world.

The product helps overcome one of the biggest challenges in providing medical equipment to the developing world. Unreliable shipping routes make it difficult and time-consuming to deliver the equipment.

If a product has an expiration date, as test strips do, the clock is ticking.

“What we’ve done is come up with an easy manufacturing practice,” Dean said. “We ship the manufacturing materials and then the customer makes them on-site.”

The test strips are printed for about five cents each by rigging a conventional ink-jet printer to shoot enzymes instead of ink.

The potential cost savings is huge. Commercially available test strips sell for as much as $1 each, and many diabetics need to use five or more a day.

Testing helps maintain blood sugar levels. When blood sugar is too high, diabetics need to take insulin. They need to eat when blood sugar is too low.

Failing to maintain blood sugar levels can lead to complications, including kidney disease, high blood pressure, stroke, neuropathy, ketoacidosis and gastroparesis.

Martine LaBerge, chair of the bioengineering department, said the private investment and multiple awards show that GlucoSense is more than a common research project.

“There is clearly a need for GlucoSense,” she said. “I congratulate past and present team members who have brought the project this far. They have all been part of something special and should be proud of themselves. GlucoSense has a bright future. With Kayla in the lead, it will surely go far.”

The team was mentored by Dean and John DesJardins, an associate professor of bioengineering, and financially supported by Clemson’s Creative Inquiry program. Several students have worked on the project, including Tyler Ovington and Alex Devon, who graduated in May and are both from Greenville.

GlucoSense began as part of the bioengineering department’s broader effort to help those in need in Tanzania. Students and faculty members are also working to introduce an infant warmer and grass-woven neck braces.

While the program started with Tanzania in mind, Accessible Diagnostics is looking to move beyond any single nation, Gainey said.

“We’ve had interest from Tanzania, Nigeria, Canada, South Carolina and El Salvador,” she said.

The company is working with U.S. and Tanzanian officials to get regulatory approval for GlucoSense.

The most recent award tied to GlucoSense came on Oct. 16 at the SC BIO Annual Conference in Greenville.

Gainey gave a six-minute presentation that won the conference’s “pitch contest.” The presentation included information about the technology, expected customers, the company’s team and how it is moving forward.

While the pitch was to a panel of three judges, it was an opportunity to expose GlucoSense to an audience of key experts. The crowd at the Hyatt Regency that day included about 200 people who work at universities and in the life-sciences industry.

The top prize came with $2,500 and independent confirmation that the company was on the right track, Gainey said.

“A lot of the people there were established entrepreneurs who have been doing this their whole life,” she said. “For them to come up and say ‘you did a good job,’ it’s a nice boost to your confidence.”

GlucoSense previously won a Lemelson-MIT “Cure it!” prize in the undergraduate category; a bronze award from the Diabetes Technology Society’s first-authored student abstract competition; and second place in the Engineering World Health’s 2013 design competition.

Dean has been working in Tanzania since she took the lead on developing infant-warming blankets.

She was among a group of faculty members and students who met with Tanzanian President Jakaya Kikwete in the capital, Dar es Salaam, in January 2012.

Diabetes is a growing problem for Tanzania, Dean said. And donations of commercially available test strips and glucometers haven’t been much help, she said. If the strips and glucometers don’t match, they can’t be used.

Anand Gramopadhye, dean of the College of Engineering and Science, said GlucoSense serves as an example of the college’s excellence in “translational” research that shows high promise in moving a prototype at lab bench to a product at patients’ bedsides.

“It is exciting to watch a student-led endeavor grow into a business,” he said. “I congratulate Drs. Dean and DesJardins and all the students who have worked on GlucoSense. I also wish Kayla and her team the best of luck as they move forward with Accessible Diagnostics. We’re proud to support them.”

Gainey, a Type I diabetic, has personal reason for taking part in the project.

“I understand how crucial glucose readings are to treating the disease,” she said. “I’ve been very fortunate to always have access to monitoring, but for people who haven’t, I want to make sure that it’s an option.”

GlucoSense is part of a broader Clemson effort to expand its bioengineering footprint beyond the main campus, especially to the Clemson University Biomedical Engineering Innovation Campus (CUBEInC) at Greenville Health System’s Patewood Medical Campus.

“Much of the GlucoSense work was done on the main campus, but more and more of our translational research is happening at CUBEInC,” LaBerge said. “Start-up companies are forming. Our corporate partnerships are producing tangible clinical applications. It’s an exciting time to be a part of it all.”

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