Diatech Diabetes Co-Founders John Wilcox & Luis E. Blanco

Insulin Pump Innovation

Though insulin pump therapy is revolutionary for individuals with type 1 diabetes (T1D), anyone who’s worn an insulin pump knows it comes with challenges. One of these challenges is infusion set failure, which prevents the accurate delivery of insulin into the body. Infusion set failures include:

• Leaks
• Kinks in tubing or cannula
• Partial or full occlusion
• Damaged sites
• Dislodgements
• Lipohypertrophy or scar tissue hinders insulin absorption.

T1Ds rely on insulin delivery and data input to manage blood glucose levels to keep a tight time in range (TIR). The algorithm can’t predict and maintain optimal control when the infusion set sites fail, and insulin is no longer absorbed properly. SMARTFUSION™’s algorithm is built to improve the safety of insulin dosing for infusion pumps and automated insulin delivery (AID) systems.

The reality is that 97% of pump patients experience insulin infusion set failures, and only 25% of insulin pump users say their insulin pump alerts them of failure.

Diatech Diabetes, a medical device company based out of Memphis, Tennessee, forged a path committed to improving infusion set failure detection. With its SMARTFUSION™ software, the platform integrates with pumps and AID systems, allowing users to monitor their infusions and, most importantly, avoid hyperglycemia.

Insulin pumps do have the technology to detect problems, Wilcox said, “However, it can be limiting. Pumps have occlusion alarms and occlusion systems that use fluid pressure to detect a blockage in the line (tubing). A blockage in your infusion set triggers an alarm when it hits a certain pressure level like a sprinkler hose plugged up and popping.”

Yet occlusion alarms are limited in their accuracy and ability to detect other failures. Occlusion sensors can often lead to false positive alarms and false negatives, leaving people with T1D confused if their infusion site is operating correctly.

Diatech’s SMARTFUSION™ software monitors insulin delivery for accuracy and infusion set failure while providing data to improve infusion set use. “People with diabetes need solutions to improve their infusion wear experience, and we really want to help with that,” said Wilcox.

John Wilcox’s Backstory

John Wilcox, co-founder and chief executive officer of Diatech Diabetes, Inc., was diagnosed with T1D on his ninth birthday. Exhibiting the classic symptoms, his general practitioner immediately tested his blood sugar and admitted him to the ER, where he stayed in the ICU for three days.

Wilcox then started insulin therapy with multiple daily injections (MDI). It was 2005, and after his healthcare team felt he knew how to manage insulin pump therapy, they started him with an Omnipod insulin pump, which he’s been on for the last 16 years.

Wilcox said he has no known family history of type 1 diabetes. His parents were both screened and had no positive autoantibodies, but his grandparents were not. His father has type 2 diabetes, though the two types are unrelated.

Through the years, Wilcox said he has experienced a myriad of successes and failures with pump therapy. “What was interesting growing up with diabetes was seeing how much the condition is managed by technology and data. Although I’m not an engineer, my training is mainly in biochemistry and diabetes education. I’ve always been super fascinated with diabetes technology. Medical devices today are incredibly innovative and can help a person with diabetes sometimes feel like they don’t have it. That’s why I’m so committed to working in this space. “ 

Wilcox received his Bachelor of Science degree in biological sciences from Florida State University (FSU) and his Master of Science degree in diabetes education and management from Columbia University. 

“I try to be an advocate as much as I can outside of working.” Wilcox travels back and forth from Memphis to Atlanta, where his wife lives, and in his free time, is committed to advocacy as a charity marathoner who has run the Boston, Chicago, and New York City Marathons while raising funds for medical research.

A Personal Connection

Co-founder Luis Ernesto Blanco, Diatech’s CTO, also shares a personal connection. Blanco’s mother was diagnosed with T1D in her fifties. The two met while working in a diabetes research lab at FSU.

“We were both mutually connected to diabetes and were passionate about the space and the technology; we were researching insulin infusion set pump failures. We started collaborating on ways to mitigate failures, which led to a biomedical engineering project, which led to essentially what we are doing today.”

Wilcox said their work primarily focuses on improving the care of people with diabetes through medical device innovation.

Innovation Challenge Award

Wilcox recently presented at the American Diabetes Association’s (ADAs) 84^th Scientific Sessions, winning the Diabetes Innovation Challenge and People’s Choice awards. The contenders present before a panel of potential funders and an audience of professionals in the field. This year’s three winners were Diatech Diabetes, Spotlight IQ, and Symbio Cell Tech.

“We don’t take this lightly. We’re just super grateful to everybody who supported us, and it puts a lot of responsibility on us because we know that people want something like this, and we need to do it right. With our partnerships with ADA and Breakthrough T1D, we feel really confident that we can deliver on this promise.”

Wilcox said the overall conference experience was awesome. “The ADA is arguably the largest diabetes conference in the world, and to not only be able to attend, which we have for many years since starting the company, but to gain the exposure they provided us was really transformational. We’ve been very fortunate to progress discussions with several manufacturers following the award.”

Connecting with Industry Leaders

Diatech has acquired a strong network of diabetes industry leaders and international research organizations, including renowned health organizations like the National Institutes of Health (NIH), Breakthrough T1D (formerly JDRF), ADA, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), AdvaMed, and the Diabetes Center Berne (DCB), where they were 1 of 3 top digital health startups for the Diabetes Innovation Challenge in 2022.

Wilcox said having DCB's resources has been amazing in the European market. “We hold a close collaboration with them. It’s an amazing group of clinicians, industry leaders, and advocates.”

The SMARTFUSION™ Solution

The SMARTFUSION™ algorithm designed by Diatech can analyze the insulin pump’s data to determine whether the infusion site placement was successful by combining real-time data analysis.

SMARTFUSION™’s preclinical results were published in the Journal of Diabetes Science and Technology Diabetes Technology Society (DTS). Diatech also published a key study with Stanford University on infusion set failure occurrences in adults and children with diabetes who use insulin pumps. 

“Our priority is showing infusion site help in real-time,” said Wilcox. “Showcasing infusion site history, failure history, and improving accuracy.”

Live Infusion Set Monitoring

SMARTFUSION™ connects to the insulin pump’s existing software interface. Its algorithms use data from the insulin pump, continuous glucose monitor and patient to monitor daily insulin dosages.

“We’re using the preexisting pump system in a new way to try and help improve detection and displaying that on a paired app,” said Wilcox. “Also, something we’re really excited about is showcasing, almost like a live tracker of your infusion set, where you can see real-time analysis and be able to see if you’re trending towards failure.”

During your boluses, you can see if your infusion set is creeping towards potentially not working or if it’s actively still a good site.

“We’re using that same sensor and modifying the way the sensor gets data, and we’re improving detection by using it in a different way,” said Wilcox. SMARTFUSION™ technology allows pump users to know the exact time when their infusion set needs to be changed, in addition to infusion set accuracy. 

Diatech was awarded a SMARTFUSION™ patent and has completed preclinical testing, demonstrating a 96% failure detection accuracy with major on-market insulin pumps. 

Infusion Site Mapping

SMARTFUSION™ can also show where on the body a person is having a lot of site failures, which can help users pick an optimal infusion site. This will help encourage infusion site relocation, which will also minimize failure. By safeguarding these problematic sites, patients can avoid threatening complications like diabetic ketoacidosis (DKA), coma and possible death.

“We are also looking at a site map where you can see spots on your body where you’ve had failures in the past,” Wilcox said. “If someone has a lot of failures in their right thigh, they might have to change it up to a different place.”

Diatech’s Future Plans

Wilcox said their business model is B2B with insulin pump manufacturers, not the pump wearers. “We already know people with diabetes have to deal with too many technology apps and sensors,” he said. “Our business model is to commercialize with pump manufacturers as our customers.”

Clinical Testing and Compatibility

Diatech just had its FDA pre-submission meeting. “We are funded by Breakthrough T1D and the National Institutes of Health (NIH) and are now undergoing our clearance and testing requirements to enter the market with one of those partners,” said Wilcox.  

“We will go through a standard testing series that will be done within the next six to nine months; during this time, we’ll showcase efficacy with an on-market pump and demonstrate its functionality. And hopefully, showcase improvements and usability and be able to file for a clearance.”

Advice for the Newly Diagnosed

Wilcox said the one thing he would like newly diagnosed T1Ds to impart is the importance of connecting with others. “There are a lot of shared experiences, and how we access them is one of the more powerful tools when it comes to adjusting to your new life,” said Wilcox.

“Finding that community of people with that shared experience to lean on and gain knowledge from, in addition to your healthcare provider, is incredibly important. Just hearing about how it sucks to wake up sometimes at three a.m., and your blood sugar is 350 because you forgot to bolus or the opposite, you have a low, or dealing with insurance issues, or dealing with access to insulin—really finding people that you can connect with, to empathize with, and have that shared living experience, is key,” said. Wilcox. “I encourage them to reach out to Beyondtype1, local Breakthrough T1D chapters, and different social media accounts to connect with other users virtually and in person.”

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