Diatech Diabetes Upgrades Diabetes Care Through AI-Powered Infusion Monitoring
Co-founders John Wilcox and Luis Ernesto Blanco are on a mission to transform diabetes management through their highly efficient AI-powered infusion monitoring software. This new technology will not just improve the lives of people with diabetes but also revolutionize the way insulin pump manufacturers approach diabetes care.
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The Challenge
Picture this: You are living with diabetes, and your pancreas either doesn’t produce enough insulin or cannot use it effectively. But you have found a convenient and precise way to provide your body with the insulin it needs, something that comes with fewer jabs than insulin injections — an insulin pump.
You learn that an insulin pump operates just like your pancreas, continuously delivering small amounts of insulin (the basal rate) to your body. You curiously study the nifty device’s parts — a compact pump that can be worn on a belt or placed in a pocket, a tube, and an infusion set with a cannula to be inserted under your skin. You are pleasantly surprised when you discover that the insulin pump also lets you deliver bolus doses (extra amounts of insulin to cover meals or correct high blood sugar levels) to your body by pressing a few buttons.
With the insulin pump attached, you feel like you have a tiny superhero by your side that keeps your blood glucose (BG) levels in check as you go about your daily routine. Then one day, you suddenly feel extremely thirsty, overly tired, and nauseated (symptoms of hyperglycemia or high blood glucose). Your continuous glucose monitor (CGM) shows BG readings above 300 mg/dL. You panic and press the button to deliver a bolus of insulin to your body and wait for the BG level to return back to normal, only to watch it continue rising.
Insulin pump infusion failure occurs when the insulin pump tries to infuse into the connected site, but the tissue is either too inflamed for the medication to successfully be delivered, the insulin leaks from the injection site, the cannula on the infusion set is bent, or there is an occlusion of the flow path causing insulin to build up in the line. These issues can cause disturbances to the flow of insulin and may prevent an accurate medication dose, resulting in an under or over delivery of insulin that can cause severely imbalanced glucose levels. The scary truth is that it is very common, with over 250K incidents reported yearly.
The trickiest part is that sometimes these infusion failures can be so sneaky that they go undetected, making efficient diabetes management quite a roller coaster ride without the fun. But fear not because Diatech Diabetes’ SMARTFUSION™ app is here to get your pump back on track.
Origin Story
John Wilcox and Luis Ernesto Blanco met at Florida State University’s senior thesis research lab and found themselves on a journey that would change not just theirs but millions of people’s lives forever.
John, who was diagnosed with Type 1 diabetes at the age of nine, had always seen the disease as an opportunity to make a difference rather than as a disability. So, for his senior thesis, he chose to address a problem he was quite familiar with — insulin pump therapy and leak detection.
“I really wanted to do something for my insulin pump. You rely on it to give you medication, and sometimes it can just leak. And the only way you know is when it’s too late,” says John.
John’s innovative idea involved a colorimetric leak detection method, where leakage would cause a visible color change. When Luis, passionate about personalized medicine and having family members living with the disease, learned about John’s ideas and struggles, he felt an immediate connection.
Driven by their shared interests in diabetes technology and entrepreneurship, John and Luis wholeheartedly took up the challenge of developing biomedical engineering solutions that would reduce the impact of insulin pump infusion failures.
During their research, John and Luis recognized a handful of critical issues in the industry.
First, manufacturers weren’t incorporating better infusion failure sensors into CGMs and insulin pumps. Instead, they focused on hardware adjustments, like changing the infusion set adhesive and altering the cannula design to prevent infusion failure. Although reducing infusion failure is important, the risk of infusion failure remains with these improved systems.
The second was the dermatological nature of infusion failures and the lack of standardization in the infusion set technology. Infusion failures could happen anytime due to compromised attachment, improper insertion, or accidental bumping into a hard surface. The existing insulin pumps had occlusion systems that detected blockages, not issues like dislodgements or leakages. In addition, the detection time varied widely, ranging from a few seconds to a few days, making potential failures life-threatening.
The third involved the industry’s shift towards automated insulin delivery (AID) — combining continuous glucose monitors with insulin pumps to regulate insulin delivery automatically. This made them realize the heightened need to make infusions monitored and safer by leveraging software solutions, which became the guiding principle behind the development of SMARTFUSION.
In 2018, John and Luis established Diatech Diabetes as an LLC in Florida. They later joined a medical device accelerator in Memphis, Tennessee, and were incorporated as a Delaware C-Corp. Over the years, they have achieved significant milestones, including receiving a phase one SBIR grant from the NIH in 2021 and establishing R&D partnerships with two insulin pump companies for full software integration.
John and Luis’s ultimate goal is to integrate their software algorithm with existing on-market pumps through licensing or intellectual property acquisition. Recently, they secured funding from JDRF, a momentous milestone for their work. With ongoing integration studies and future clinical trials, they are on track to bring SMARTFUSION, their pre-FDA-approved algorithm, to fruition, representing a promising advancement in diabetes care.
Under The Hood
SMARTFUSION™ is a software-based platform that monitors insulin infusion in real-time, providing critical benefits for people with diabetes and insulin pump manufacturers. It ensures proper insulin delivery and alerts users to replace the pump’s disposable part when needed to prevent potential hyperglycemia and even fatal outcomes.
In technical terms, SMARTFUSION integrates with existing on-market insulin pumps and accesses their onboard occlusion system sensors. Data from the sensors are then captured, processed, and analyzed to detect occlusions, leakages, failed insertion, and dislodgement. Once a failure is detected, the app sends instant personalized alerts to patients and caregivers. Preclinical trials have demonstrated an impressive 97% classification accuracy of the SMARTFUSION algorithm, establishing its reliability and effectiveness.
In an already saturated insulin pump market, manufacturers can leverage SMARTFUSION as a value-adding feature to differentiate themselves and be the preferred option for people with diabetes.
To underscore the importance of this technology, Luis extends the results of a survey involving more than 700 participants. It revealed that nearly 41% of the respondents experienced at least one infusion failure per month. “Patients usually receive a box of 10 infusion sets at the beginning of each month. A failure rate of 10% indicates that one of those 10 sets is already faulty. Some participants even reported multiple failures per set, which raises concerns about diabetes control and therapy satisfaction.”
Patients starting to lose trust in their insulin pumps poses a significant obstacle to achieving the ultimate goal of automation in diabetes management. SMARTFUSION aims to address this challenge and help manufacturers fully realize the potential of automation through comprehensive infusion monitoring.
Last Words
Insulin pump infusion failures have far-reaching consequences. Beyond physical effects, they take an emotional toll on people with diabetes due to the inability to predict how they will feel on any given day. In addition, the financial implications of failed devices and the high cost of insulin add to patient frustration, further complicating an already complex issue.
Fortunately, Diatech Diabetes’ SMARTFUSION technology offers relief to millions of people suffering from infusion failures worldwide. What’s inspiring is that the passionate team behind the company has a personal connection to diabetes, which drives their dedication and understanding of patients’ needs and challenges. Their technology is truly remarkable in that it not only focuses on improving the lives of people with diabetes but also contributes to the long-term goal of full automation in diabetes management.
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Published: Sep 14, 2023