Ever wonder what it might be like if we could ditch all of our clunky glucose monitoring gear for a tiny sensor, smaller than a sesame seed, implanted under the skin that would continuously send readings to a smartphone? That's the vision of Integrated Medical Sensors, a relatively new CGM startup in Irvine, CA, borne out of Caltech research, developing a continuous glucose monitor unlike anything else on the market. Their implantable sensor is so small it could easily get lost on the tip of a finger or the face of a penny, and it will last under the skin for as long as six to nine months!
It's still a ways down the road (if it actually ever does come to market), but what they have in mind is quite interesting and worth a deeper look. We invited IMS to demo at our D-Data ExChange event last November, and since then we've had the pleasure of connecting with members of their team about their work. Here's what IMS tells us, in a nutshell, about its team and the system they're building.
This project was started at Caltech (the California Institute of Technology in Pasadena) as Dr. Mujeeb-U-Rahman’s graduate research project in 2010. He started from scratch based on his interest and motivation to develop a high-impact biomedical device that can benefit millions of patients.
Mehmet Sencan was the first student to join Dr. Rahman in 2010, followed by two other class fellows. The core team has been working together since, first at Caltech and later at IMS.
The core team consists of those three Caltech graduates:
- Dr. Muhammad Mujeeb-U-Rahman - PhD in Electrical Engineering whose initial research focused on development of miniaturized implantable wireless sensing platforms. His post-doctoral work focused on development of a wireless glucose sensing platform consisting of the miniaturized sensor he developed for his PhD along with a wireless transmitter system and smartphone app for data processing and management. He has a very personal connection and motivation as his mother is diabetic.
- Dr. Meisam Honarvar Nazari - PhD in Electrical Engineering whose research was focused on low-power, high-performance Mixed-Mode Integrated Circuit design with applications for short distance communication and biomedical applications. His post-doctoral work focused on development of high-performance ASIC design for the implantable glucose sensor project and design of wireless reader hardware. He has a personal connection with diabetes too, as his aunt passed away from the effects of diabetes complications.
- Mr. Mehmet Sencan - BS in Applied Physics whose undergraduate research focused on optimization of electrochemical sensor geometry through multiphysics modeling, simulation, fabrication and testing. He also developed instrumentation setup to functionalize and test miniaturized electrochemical sensors for glucose and other analyte sensing. His close friend and then-college roommate was living with diabetes.
The IMS sensor they've created is the world’s smallest -- smaller than a sesame seed on a bagel (0.6mm x 3mm x 0.1mm). It goes under the skin 2-3mm, as compared to transcutaneous CGM sensors which are closer to 10mm deep. This is more than 1,000 times smaller than the next smallest sensor being developed by other companies and more than 10,000 times smaller than currently available sensing devices.
Implantation & Removal
The sensor will be injected under the skin using a simple needle (smaller than the needle used for blood draws; significantly smaller than needles used for other implants) and trocar injector (the first version has been developed and tested).
The sensor has the potential to work for 6-9 months before it stops functioning accurately. While inserted, talks directly to a Transmitter worn on the arm, communicating to a mobile app using Bluetooth Low Energy. It will be removed using a simple outpatient procedure consisting of making a small incision (under local anesthesia) and pulling the sensor out via a connected biocompatible thread.
IMS says their current MARD (mean absolute relative difference) value is comparable to last generation of FDA-approved sensors, and will be further improved as their chemistry and signal processing improves. Their main emphasis so far has been development of the hardware platform. With that complete, they can now shift focus to "chemistry optimization" to improve their MARD and device longevity. "Good news is that many experts have been working on this chemistry for a while and there are known techniques to optimize its performance," the partners tell us.
Data Connectivity & Interoperability
The IMS Transmitter -- a small white plastic block the user straps to their arm or wrist -- uses Bluetooth Low Energy to communicate with a smartphone.
OK, this seems a bit bulky by today's standards and doesn't look all too appealing. And it's not something that would even be too discreet worn underneath clothing. The IMS team points out this is a first-generation prototype. The next version will be just one-third of the size, and they're working to integrate their Transmitter's functionality with wearable tech already on the market, i.e. smartwatches and fitness tracking bands. So it's possible once this is ready for prime time, the Transmitter won't even be needed.
The mobile app provides data viewing and sharing, by communicating data to a secure database; allows users to add food and activity data and set up alarms; and will integrate with lifestyle apps (e.g. fitness tracking) to help track daily routines like workout schedules and dining times and options.
The standard CGM profile used to send data over Bluetooth Low Energy allows data integration with other devices once the user sets up a secure connection.
Sure, there's the similar Eversense CGM by Senseonics currently under FDA review, but patients don't have access to that yet either, and IMS believes their version will be even smaller and better for PWDs. Eversense's Transmitter is a black plastic square that's chunkier than IMS's, and must be worn directly over the sensor insertion spot.
To illustrate their edge over the competition at our #DData17 event in November, IMS showed this breakdown of the various companies with existing CGM products or working on next-generation technology:
IMS says they have already developed a fully functioning version of all system components and tested those in labs with small animals. They hope to begin human trials soon, and complete their first regulatory submission in Europe by 2020, and to FDA by 2021.
Are they looking to license or sell this technology to a larger company for eventual manufacturing and marketing? They didn't comment on a possible acquisition, but the IMS leaders did say, "We would like to work with a company with established sales, marketing and distribution channels to be able to reach to nd users in a fast and reliable manner."
Very interesting! We certainly have our doubts about how soon or realistic this type of implantable tech may be, but it's certainly worth knowing about.