Objective

The objective of the proposed work is to develop and commercialize the smallest, least expensive, and most accurate insulin pump for use in artificial pancreas (AP) products, based on the most popular microfluidic technology of the past two decades and breakthrough nanoscale gas compressor technology we developed at NASA.

Background Rationale

Untreated, type 1 diabetes (T1D) is deadly. Improper treatment eventually leads to life-altering complications such as blindness, kidney failure, and amputations. Proper treatment places a high burden on the individual. For most, this involves measuring blood glucose every few hours, planning every meal, injecting insulin several times a day, and keeping track of many other factors that change blood glucose levels. Thankfully, since the first person, Leonard Thompson, who was successfully treated with insulin in 1922, significant effort has been undertaken to reduce the burden of proper treatment of T1D.

Today, with the advent of continuous glucose monitoring (CGM) systems, mainly driven by the efforts of JDRF and medical companies like Medtronic, Dexcom, Abbot, and Eversense, the burden of tracking blood glucose levels has been significantly reduced. In addition, JDRF’s steadfast support since 2005 to automated insulin delivery systems, colloquially referred to as the artificial pancreas (AP), has led to a favorable regulatory environment, coverage by most insurance companies, and growing adoption among those seeking to reduce the burden of treating T1D. Since 1963, when Dr. Arnold Kadish demonstrated the first backpack-sized AP, largely through JDRF’s leadership and support, AP products have become smaller, safer, and less expensive. Today, the latest Omnipod from Insulet, a disposable closed-loop patch, is the size of a matchbox and works together with a CGM, costs about $10 a day.

As we celebrate 100 years since the first successful insulin therapy for T1D, we ask where the next significant advancement toward user-centric AP products will come from. At Torramics, we are excited to propose the Torramics nanopump. This breakthrough insulin pumping technology enables AP products of the future that are about the size of a half-dollar coin, more accurate, even under extreme conditions, and cost significantly less than anything on the market today or on the drawing board.

Description of Project

At Torramics, our mission is to create the smallest, safest, and least expensive insulin nanopumps to enable existing and upcoming artificial pancreas manufacturers to build next-generation user-centric products for individuals with diabetes.

Our nanopump is built with semiconductor technology that combines proven nanofluidic pumps that have been the standard in the microfluidic industry for the last two decades and a breakthrough gas compression technology that we developed at NASA. This synergy of mature and breakthrough technologies enables us to reduce the size of the insulin pump by over 100 times while improving accuracy and reducing costs.

Using standard semiconductor materials and processes enables us to scale to billions of nanopumps a year at existing semiconductor manufacturing facilities. Our nanopump is designed to minimize production costs through simple integration, compatibility with most sterilization techniques, and self-test capabilities to maximize the quality of shipped products and provide the individual with peace of mind.

Anticipated Outcome

We anticipate that our nanopump will ultimately enable artificial pancreas (AP) products to fit inside a half-dollar coin, to be more accurate, even under extreme conditions, and cost significantly less than anything on the market or the drawing board today. The resulting AP products will dramatically improve the lives of millions of individuals with Type 1 diabetes by radically increasing convenience and safety while drastically reducing the price.

Relevance to T1D

The desire for more user-centric artificial pancreas (AP) products is shared by most individuals with type 1 diabetes (T1D).

The insulin pump is the main bottleneck that limits the convenience, safety, and cost of the current AP products, making them less user-centric.

Given that almost every AP manufacturer has a radically different pumping mechanism goes to highlight how big this problem is, as manufacturers generally tend to share suitable solutions. Since current and upcoming solutions are not great, the industry has labeled them "YAP", which stands for "yet another pump."

An ideal insulin pump is bio-compatible, manufactured for pennies, and simple to integrate, sterilize and test.

The Torramics nanopump is the only insulin pump that checks every box and then some, enabling radically more user-centric AP products from the start, with the potential to improve AP products to the point that living with T1D for some will become an afterthought.

With version 1, we expect our disposable nanopump will be 100x smaller, 10x more accurate, and 10x less expensive to manufacture than a comparable syringe pump in an Omnipod. Our nanopump should enable AP manufacturers to modify their existing FDA-approved AP products to reduce the size, increase accuracy, and decrease cost.

Then, with version 2, we will leverage mature "system on a chip" technology at TSMC to have the CPU, Bluetooth, NFC, and power management controllers on the nanopump. This modification will make it even smaller and cheaper. So much smaller in fact, that with U1000 insulin, the entire AP product may fit inside a half-dollar coin.

Then, with version 3, we will integrate multiple discrete pumps on a single chip by merely changing the layout and the software. This change enables various medications and insulin to be dispensed through the same device. For example, a local anesthetic can be injected to reduce pain and inflammation upon insertion and during activities that may cause flare-ups. Anti-coagulants and antibiotics can keep the site healthy and open for longer and healing promoters can reduce infections and skin damage when the AP product is ready to be removed.