FreeStyle Libre 14 day System: Interview with Chris Thomas, Director of Biosensing Technology, Abbott

Medgadget has previously reported on Abbott’s FreeStyle Libre 14 day system, most recently when we interviewed them at CES 2019. The company has aimed to help people with diabetes move away from traditional fingerstick testing towards continuous and minimally invasive glucose monitoring, which results in better health outcomes and overall diabetes management.

The FreeStyle Libre 14 day system incorporates a wearable sensor that is placed on the back of the upper arm. The wearer can use their smartphone to get a real-time glucose measurement simply by holding it near the sensor. An app on the phone will display current glucose levels, information on how glucose levels are changing at that moment (i.e. rising or falling), and trends in glucose levels over the previous eight hours and up to 90 days.

The sensor is water-resistant and can be worn for up
to 14 days. The company reports that users can shower and swim as normal, with
no effect on device performance. A tiny filament samples the interstitial fluid
at regular intervals to assess glucose levels. 
 

From the app, the data is also automatically
uploaded to the cloud, and can be accessed by clinicians to assist them in
making treatment decisions. See a promotional video from Abbott about the
system below.

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Medgadget
had the opportunity to talk to Chris Thomas, director of biosensing technology
at Abbott, to discuss advancements in this field and what the future holds for
glucose monitoring and diabetes management.

Conn Hastings, Medgadget: Please give us an overview of glucose monitoring technology as it currently stands. What challenges do most patients face in routinely monitoring their glucose levels using traditional fingerstick methods?

Chris Thomas, Abbott: Traditional glucose monitoring hasn’t changed for
decades. It involves sticking a finger, putting a drop of blood on a test strip,
inserting it into a reader and
waiting for a glucose value. People with diabetes sometimes stick their fingers
up to 12 times a day to maintain glucose levels. It’s painful, invasive and a
hassle.

That’s
when early versions of continuous glucose monitors (CGMs) were introduced and provided
some relief for diabetes patients; however, they were bulky, required users to
carry heavy handheld receivers that weigh as much as bricks, and had sensors
that only lasted a few days. And on top of this, prices were astronomical.
These factors made CGMs undesirable for most and not a viable alternative to
fingersticking.

That’s why Abbott’s goal is to make
the traditional methods of glucose monitoring (e.g., blood glucose meters,
lancets) a thing of the past and irrelevant for the more than 425 million
people with diabetes around the world. By introducing our FreeStyle Libre and
FreeStyle Libre 14 day CGM systems, we have changed the way people with
diabetes manage their condition with a series of firsts: the first to eliminate
painful fingersticks, the first factory-calibrated CGM and the first affordable
CGM.

Medgadget: How has wearable/wireless technology changed things for patients with diabetes?

Chris Thomas: Traditional blood glucose monitors only provide readings that represent distinct points in time. People with diabetes depend on this information to make important health decisions, but glucose levels change throughout the day.

Wearables such as
the FreeStyle Libre 14 day system allow people to see where their glucose
levels are, where they’ve been and where they are heading. They can check their
glucose anytime, anywhere, and as many times as they want. By seeing this
information, these trends and patterns, they can make informed treatment
decisions, resulting in tighter control of their glucose, spending more time in
range and less time in hypo or hyperglycemia – all things that contribute to
better overall health and improved outcomes.

Medgadget: Please give us an overview of the FreeStyle Libre system and how it addresses the shortcomings of previous approaches.

Chris Thomas: The FreeStyle Libre CGM system is a scientific breakthrough that fundamentally changed diabetes management by freeing people from the constant pain, burden and hassles of routine fingersticks. With a quick, one-second scan of the FreeStyle Libre reader or smartphone over the sensor (about the size of two stacked quarters) worn on the back of the upper arm, a user gets a real-time, every minute glucose reading, historical trends and patterns, and arrows showing where glucose levels are going. It provides actionable information that leads to a better understanding of glucose levels and treatment decisions around insulin, nutrition and other medication.

We built the FreeStyle Libre technology
with a patient-centric approach that includes the smallest and longest-lasting
self-applied glucose sensor currently available today for up to 14 days. We
also designed the device with accessibility and affordability in mind – pricing
it at a fraction of the cost or roughly 70% lower than other CGMs – to make it
more widely available for people with diabetes around the world.

Because of its ease-of-use, accessibility and
affordability, and evidence of improved health outcomes, Abbott’s FreeStyle
Libre is the leading CGM system worldwide and has changed the lives of more
than 1.5 million people with diabetes across 46 countries – a true testament to its
groundbreaking technology.

Medgadget: Clinicians and caregivers can be permitted to access the data the FreeStyle Libre collects. How has this helped patients to improve their glucose management and health?

Chris Thomas: Doctors and patients tell us FreeStyle Libre is changing the standard of care, impacting both the people living with it and their doctors who treat them. It’s giving patients and their doctors actionable data they need to manage their condition, which involves adjusting medications, diet or exercise. This is also supported by Abbott’s real-world data from more than half a million users showing that users test their glucose levels on average at least 13x daily, 3x more than current clinical recommendations. Clinical evidence also shows frequent use of FreeStyle Libre is associated with better glucose control, more time in optimal glucose range, and improved HbA1C.   

Medgadget: Do you envisage additional functionality for the system in the future, whereby the app can recommend when and how much insulin (or other treatments) that the patient should use, based on predicted glucose levels?

Chris Thomas: Wearable technology like FreeStyle Libre has immense potential for what it can achieve. We are working to broaden its impact to more and more people, and we are innovating everyday so we can continue to improve the benefits of this technology and exploring partnerships to make the daily diabetes routine for patients more convenient and streamlined.

We announced a partnership
with Bigfoot Biomedical to develop and commercialize diabetes management
systems integrating Abbott’s FreeStyle Libre sensing technology with Bigfoot’s
insulin delivery solutions in the United States. Bigfoot will utilize this
technology in the development of the first-ever personalized, user-friendly
systems intended to optimize insulin delivery. We’re also working with Novo Nordisk to make diabetes management easier by integrating
Abbott’s FreeStyle Libre and connected insulin pens. The integration will
enable healthcare professionals, caregivers, and people with diabetes to view
glucose and insulin data together.

Additionally, we are thinking about the next frontiers where
data-enabled devices are going to take people and the broader medical system.
How will artificial intelligence and machine learning aid diagnosis and improve
accuracy? And how it all might both improve the way we live and do it at lower
costs?

Medgadget: How do you see this type of technology developing? Do you think that AI and machine learning will have a role in this?

Chris Thomas: As I mentioned earlier, with more than 425 million people living with diabetes globally, there’s immense potential to bring Abbott’s life-changing technology to more people. We’re continuing to drive the development of sensing technologies that are accurate, affordable and accessible to help people with diabetes achieve better health outcomes, and we’ve only just scratched the surface.

There has been a buzz around AI and machine learning in healthcare
because device derived data and the clinical insights produced from it will be
the value driver in medical technology. Advanced algorithms and machine
learning systems will analyze those data in near real‐time, proactively surface
clinically relevant trends and patterns, and recommend personalized treatments.

Additionally, we need to think beyond individual technology advancements and think more holistically. Companies must be more willing to partner to create lasting innovations, and we need greater interoperability between devices. Diabetes care continues to pioneer health disruption and set the example for others to follow, and Abbott is proud to be at the forefront of the diabetes management revolution.

Product page: FreeStyle Libre…

Flashbacks: Abbott’s FreeStyle Libre 14 Day Flash Glucose Monitor Approved in U.S.; Abbott’s FreeStyle Libre Pro Continuous Glucometry System for Professionals FDA Approved…FDA Approves Abbott FreeStyle Libre Flash, a CGM That Requires No Blood Sample Calibration…