People with diabetes who wear an insulin pump and continuous glucose monitor (CGM) have long been dreaming of an integrated solution that would let them wear just a single device on their bodies, instead of two separate units poking their skin in different places. An Oregon-based startup may well have the answer.
“The reason we got into this was ‘device burden,’ where people have to use several devices and it’s cumbersome,” says Dr. Ken Ward, a bioscience engineer who’s been involved in glucose sensing at companies like Bayer and iSense before co-founding PDT. “Despite the science showing these devices are very effective, many people don’t wear their pumps and sensor all the time. Our belief is ‘device burden’ has a lot to do with that, so we want to create a single device where the cannula and glucose sensing is all-in-one.”
PDT says the insulin delivery will not interfere with CGM readings — enabled by their hollow sensor with “redox mediator” technology that’s different than what existing CGM manufacturers use today.
The company has a working prototype and is currently seeking investors and research partners, according to CEO and co-founder Robert Cargill.
Some may remember that Medtronic was working on a similar integrated solution called Minimed Duo about 5 years ago, but that product was never launched. PDT is now poised to be the first to bring this type of combo device to market.
Dr. Ward says PDT had to turn to novel technology, because research shows that that if you put the insulin infusion set too close to existing CGM sensors, you experience a huge rise in glucose levels, up to 800 or 900 mg/dL! They discovered this in pig studies concluded about 15 months ago in which the infusion sites were only few millimeters apart.
The cause: preservatives used in insulin that react with traditional CGM sensors, meaning they’d either have to take out the preservatives (not recommended) or find a different way to do the CGM sensing.
Watch this video describing PDT’s new integrated solution. Here are the specs:
- World’s first “hollow” CGM sensor that uses a different type of interstitial fluid sensing so that the CGM readings aren’t interfered with by the insulin delivery.
- A single inserter device will attach the combined unit to the body, for 7-day wear.
- After insertion, you’d snap a transmitter (which resembles the form factor of an Omnipod) onto the top for the CGM capability.
- It will have a less than one-hour warmup period before CGM readings and alerts are activated.
- A built-in Bluetooth transmitter will communicate with the cloud and smartphone tech. PDT says it’s currently looking at Android-only compatibility first, and iOS connections would come later.
- PDT says it’s pursuing “non-adjunctive” status, meaning the CGM results could be used for diabetes treatment and dosing decisions, without a confirmatory fingerstick required.
- Their first iteration is designed for traditional, tubed insulin pumps, but they’re creating a patch pump concept as well. That would also serve as an option for those using insulin pens; the user would insert the pen needle into a top port on the CGM transmitter for insulin delivery in that spot without an extra injection site needed.
PDT conducted its first human clinical study in 2018 involving 10 patients. Results showed CGM accuracy between 10-14% — which is equivalent or better than what most current CGM manufacturers saw in their first-generation products.
To date, PDT has accrued $6 million in funding to help pave the way to that first human study last year.
In 2016, the JDRF announced a partnership with Pacific Diabetes Technologies to create this new generation of combined single port soution. That $1.14 million grant was on top of past funding from NIH and Helmsley Charitable Trust, prepping the company for its initial and future clinical trial work.
Unfortunately, timelines have been pushed back a bit. PDT had stated it hoped to begin pivotal trials in 2018, but that hasn’t happened yet.
CEO Cargill tells us PDT needs about 24 months from now to get to an initial filing t start their pivotal trials, assuming they can find adequate funding to bring their R&D team up to the needed 18-20 people. He estimates needing $1.5-3.0 million per year for the next two years to make this happen. Then about a year to conduct those pivotal trials and prepare for FDA filing… so roughly 2023.
Still, the JDRF and PDT teams are excited and hopeful about the quality of life improvements that a solution like this could bring to the lives of people living with type 1 diabetes.
“There hasn’t really been a motivation for new innovations in infusion set technology, but all the recent research has re-generated the interest and excitement,” Dr. Ward says.