Executive Summary

We're building​ a small wireless device to collect data from blood glucose meters used in the management of diabetes. It replaces the need for patients to have a cell phone and the user experience is seamless. It just works! Finally, every organization who needs access to blood sugar data from their hardest to reach and most costly health plan members will be able to have it. For this team, it's a simple upgrade to the research device we first deployed nearly 15 years ago. To others, it's magic.

The following information is intended to share insight as to why a cheaper, faster, better wireless device is needed and how we plan to commercialize it.

The Opportunity

Commercial information technologies for helping patients better manage chronic diseases like diabetes assume that:

  • doctors are willing to be at the center of day-to-day outpatient self-care;

  • every patient has a smart phone with a data plan; and,

 

  • every patient is willing to spend more time to share data with their doctor.

All of these built-in assumptions fail miserably when compared to the real world.

 

This high-tech data sharing scenario is a reality for fewer than 5% of the doctor and patient relationships. Because of the DiaTrends team's decade of primary research, including hands-on experience working with thousands of patients, we know that the vast majority of people will never use the current generation mobile apps. No wonder health plans refuse to pay for them.

 

The Team

The founders behind DiaTrends are informed like no other team due to the research & development that went into the design, build and field testing of the GlucoMON®-ADMS by Diabetech. It's finally time to commercialize the concepts first identified by Diabetech's research program so we've spun out DiaTrends as the vehicle to commercialize that experience. We know that in order to have a significant impact on the masses, passive data collection is an absolute requirement. Only then can you hope to work with patients to change behavior with proven effective methods involving data driven interventions.

 

Diabetech's pioneering research culminated in several peer reviewed journal publications. This evidence base resulted in licensing of the Diabetech technology to medical device and disease management companies in the USA and UK.
 

Barriers

Doctors and other medical professionals do not get paid to review outpatient self-reported data. Patients are far too busy to bother with uploading blood glucose meters and other biometic sensors.

Since 2009, when Diabetech first licensed its technology, companies selling data-driven patient management devices and programs have continued to struggle. This is because every company in the space is totally dependent on a scenario built for motivated patients using a smart phone with a data plan. These companies also assume that the patient's doctor is willing to review their patient's blood sugar data and that they will then prescribe timely adjustments to the patient. This belief has proven time and again to exist only as fantasy.

 

In response, these same companies believe that their systems will be more effective and attractive to payers if doctors had access to even more data. Thus, the push for incorporating the patient's photos of meals, accelerometer data from exercise bracelets, location, temperature, blood pressure, pulse oximetry and every other sensor under the Sun. "Combine all of this data in an Artificial Intelligence platform and the problem could be solved", so they want payers and investors to believe. Meanwhile, proven elegant patient self-directed protocols sit idle.

The Solution

The Token is the only tool capable of capturing accurate outpatient data from high cost, hard to reach patients.

A lot has happended since 2009. The GlucoMON research platform ceased operations in 2011. Bluetooth Low Energy (BLE) has become nearly pervasive. And, the numbers of people with poorly controlled diabetes continues to grow at an alarming rate along with corresponding costs to payers and society in general.

 

DiaTrends is developing the smallest, lowest cost, coolest and easiest to use standalone device for managing and collecting data from outpatient biometric sensors used by people with diabetes. Availability anticipated in 2018.

 

We call our device the 'Token' and it's the basis of our proprietary method for overcoming the many barriers to improved patient outcomes. The Token does not rely on a cell phone or even a home network. Everything works as soon as the patient opens the box.

The Market

There are currently more than 350M people previously diagnosed with diabetes worldwide. That figure is growing each year at a compounded rate of nearly 5% per annum. The DiaTrends behavior change protocols licensed from Diabetech have previously demonstrated the potential for a Return on Investment (ROI) of 3 to 6 months depending on the patient sub-group.

From this very large and growing pool, we are focused on the highest cost and hardest to reach patients. There are already plenty of tools available for patients who are willing to taken on the extra work of using highly interactive iOS and Android mobile apps, However, this demographic represents the least cost to the system. DiaTrends system will get actionable data from the majority of high risk, high cost patients because it's the easiest to use, most effective and available at the lowest cost vs. the alternatives.

The Business Model

Health plans and tech companies selling to health plans are still waiting for patient data to drive their systems. The Token gets data when other systems can't. That's why they'll buy.

 

DiaTrends is discussing pre-orders for the Token plus a recurring management fee with our previous research pilot sponsors.

Click on the video to watch just one example of how payers want to use remote sensor data. For example, the NHS piloted a remote blood sugar monitoring program with a Diabetech licensee as a way to reduce office visits for their diabetic patients during pregnancy.

The prospects for providing a significant technology upgrade to organizations familiar with the previous research translates into abbreviated sales cycles vs. our competitors. These prospects include the largest blood sugar monitoring device manufacturers, payers including Kaiser Permanente, the National Health Service in the UK, Blue Cross Blue Shield franchisees, and State's Medicaid disease management programs. We also know large self-insured employers including AT&T, and others.

Here's where we differ from companies in the space with less experience. We know what works and what doesn't. So, it makes sense that we could share the risk with our clients... but only if they heed our advice and implement the technology under one or more of our proprietary protocols. The Token is just a tool and data is just data. But if you use it in a way that has already been vetted in randomized, controlled clinical trials then we pretty much know what we're going to get. If our clients prefer to build their own road and just leverage the Token's unique ability to collect accurate outpatient data then that's OK, too.

Regulatory

The device​ and software system will seek classification as a Medical Device Data System, a low risk category as defined by the FDA's classification regulations. Subsequent versions of the system may include application for 510k marketing clearance as far as data visualizations and other proprietary forms of feedback wherein the data has to be manipulated for its intended effect. Our primary go to market plan involves sales of devices and licensing of the data service to third parties who will in turn seek their own 510k using the DiaTrends clinically validated research formats as well as their own innovative approaches involving data manipulation.

Fundraising

We are currently in discussion with angel investors, seed stage venture capital firms and preparing to crowd fund a portion of the startup fabrication and development costs. Inquiries welcomed.

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