We hear it repeatedly: “Technology is transforming healthcare.” We see the evidence throughout our healthcare system, from precision medicine to wearable fitness monitors, to electronic health records to telemedicine. Does that mean all technology improves healthcare? No, and the challenges are plentiful. So how do we create something useful, that delivers the intended health outcomes but is still affordable? Delivering on the promise of health technology is harder than it looks.
With the inexorable growth in healthcare needs, “promise” is not enough. Today in the U.S., 100+ million people have at least one chronic disease.[i] That’s 100 million people dealing with a condition every day that cannot be prevented by a vaccine or cured by medicines—juggling their daily lives AND the unending demands these conditions impose. At Abbott, we are on a mission to develop life-changing technology that helps people with chronic conditions live better, healthier lives.
One area of focus for us is diabetes. There are more than 30 million people in the U.S. and 400 million globally living with this condition1,[ii]. Diabetes is a global epidemic that never sleeps, requiring constant monitoring of glucose levels and lifestyle adjustments to prevent serious health complications.
Explosive Growth Necessitates Disruption
Despite this, glucose monitoring hadn’t evolved for decades: insertion of a test strip into a glucose meter, a painful fingerstick (multiple times a day), a drop of blood on the test strip, and an anxious wait for the result. This provides people with diabetes one measurement at a certain point in time with no historical context, and no idea if the glucose level is falling or rising.
Studies show that the more people know about their glucose levels, the better they manage their disease[iii]. The American Diabetes Association recommends people with diabetes fingerstick three to six times a day[iv] to collect multiple “snapshots” of their glucose levels, but this doesn’t always happen because it’s painful and inconvenient[v]. For the millions of people with diabetes in the U.S., there was an unmet need for an alternative way to measure glucose levels.
The Search for a Better Way
About 20 years ago, patients were exposed to a new way of tracking glucose levels with the creation of continuous glucose monitors (CGM). CGMs measure glucose levels in the tissue fluid every few minutes. CGM sensors are placed just below the skin and connect to a transmitter that sits on top of the skin, which sends the information to a monitoring and display device. Unlike the “snapshot approach of a blood glucose meter, a CGM measures glucose continuously allowing users to see both historical and current glucose allowing them to have greater insight into their condition.
The problem? Early CGMs were bulky, expensive, painful to apply and hard to use – additionally they required multiple fingerstick tests per day to calibrate the continuous sensor, and even after that, were not accurate enough to allow users to adjust their therapy, if needed. As a result, CGMs remained a niche product for those past 20 years, with limited reimbursement coverage, and only used by those with the means and dedication to overcome the numerous barriers.
Not Just Product Design, but Process Design
Abbott recognized shortcomings of existing technology and set out to design the FreeStyle Libre family of products, systematically using novel technology and a user centric design focus to address all the drawbacks of the existing CGM systems. As an example, at the time, other CGM devices could not be used for more than seven days before the sensor needed to be changed. Abbott developed a new “wired enzyme” sensor technology, which used an electrically-connected enzyme in the sensor to produce electrons from glucose in the interstitial fluid. This allowed the FreeStyle Libre 14 day sensor to be worn for up to 14 days, which ultimately enabled a price-point that people and payors found acceptable, while delivering greater convenience for the user. At the same time as extending the sensor wear through novel chemistry, we invested heavily in manufacturing processes that allowed us to introduce the concept of factory calibration for CGM sensors for the first time.
This allowed users to eliminate the multiple daily fingerstick calibrations of the CGM while also improving accuracy to the point that users were able to use their CGM results to adjust therapy,
What Does This All Mean?
With the FreeStyle Libre family of products, we’ve made significant advances in acquiring data painlessly and effortlessly while providing visualization formats to help people understand this data to better manage their diabetes. However, this is just the beginning and the need for continued advancement in technology that changes lives is great.
For decades, healthcare data was recorded at the doctor’s office or in a controlled study. Affordable, wearable technology changes that dynamic. More accurate, accessible data empowers patients and allows for remote data collection without frequent doctor visits.
The integration of technology platforms could further advance disease management and treatment. Look at diabetes and heart disease – there is often a link between the two; people with diabetes are at greater risk of developing heart disease[vi]. Data from CGMs, when evaluated over time with another technology such as a heart rate tracking device, could reveal how changes in glucose impact heart rate or other CV indicators. That information could lead to individually tailored therapies.
It doesn’t stop there; we need to capitalize on machine learning and artificial intelligence and move beyond simply translating data into actionable information. By adding guided interpretation, we can anticipate a day where predictive and prescriptive analytics are part of care decision making.[vii]
Enabling better, simpler, data collection, pushes health technology to the next level – truly transforming the way people engage with their health.
- [i] U.S. Centers for Disease Control and Prevention. Chronic Disease Overview 2017 https://www.cdc.gov/chronicdisease/overview/index.htm. Accessed April 24, 2018.
- [ii] International Diabetes Federation. IDF DIABETES ATLAS – 8TH EDITION. http://www.diabetesatlas.org/
- [iii] Bergenstal, R. M., Dunn, T., Jangam, S., Hayter, G., & XU, Y. (2018). Real-World Improvement in Above-Target Estimated A1c with Sequential Use of Professional Flash Continuous Glucose Monitoring for Individuals with Diabetes. Retrieved November 15, 2018, from http://diabetes.diabetesjournals.org/content/67/Supplement_1/74-LB
- [iv] American Diabetes Association Standards of medical care in diabetes 2014. Diabetes Care January 2014, v37 suppl1 s21-22
- [v] Ong, W.M.; Chua, S.S.; Ng, C.J. (2014) Barriers and facilitators to self-monitoring of blood glucose in people with type 2 diabetes using insulin: a qualitative study. Patient Preference and Adherence, 8. pp. 237-246.
- [vi] Circulation Research. “Diabetic Cardiomyopathy”. http://circres.ahajournals.org/content/122/4/624. Accessed May 10, 2018.
- [vii] Pharma Intelligence. “Artificial Intelligence Brings Wave of Future Health Care Innovation – Embrace It of Be Left Behind.” July 31, 2017. https://pharmaintelligence.informa.com/resources/product-content/artificial-intelligence-and-future-health-care-innovation. Accessed April 24, 2018.
Indications and Important Safety Information
FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The systems are intended for single patient use and require a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The systems do not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The systems are not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.