Piloted by the growing demand from
consumers to take control of their health, the use of wearable medical
monitoring devices and health technology have tripled in the last four years.
From simple fitness trackers to wearable ECG monitors, biosensors to wearable
blood pressure monitors, the illness prevention devices are changing the
healthcare infrastructure and enabling users to engage with health management
practices for overall well-being.
What is a Continuous Glucose Monitoring System?
Continuous glucose monitoring (CGM)
devices allow people with Type-1 and Type-2 diabetes to check their real-time
glucose readings every five minutes, which totals up to 288 readings in a day.
Tracking and monitoring glucose levels can help diabetics to make informed
decisions about food choices, exercises, medications, and other aspects of
diabetes management. CGM eliminates the need to guesswork about daily patterns
and fluctuations in glucose levels. The CGM system does not require finger
pricks, which might be painful and difficult to manage frequently. Generally,
CGM can be segmented into three parts, a tiny sensor wire, transmitter, and
receiver.
The tiny sensor wire is inserted just
under the skin (subcutaneous tissue) of the arm or abdomen to measure glucose
levels. The sensor measures the level of glucose found in the interstitial
fluid every 10 seconds and changes into electrical signals, which represent the
amount of sugar in the blood. Then, the transmitter sends data wirelessly to
the receiver, which displays glucose levels and trends. Nowadays, CGM devices
utilize Bluetooth technology to transmit blood glucose information directly to
compatible smartphones or tablets. Some CGM devices include cloud-based
reporting software to display information stored in the cloud to a selected
number of users. Some other CGM devices also allow the user the flexibility to
input information about diet and physical activity to further help with
tracking glucose trends.
Fingerstick blood glucose
measurements offer immediate insight into what is happening at a single moment
and no information on whether the glucose levels are rising, falling, or
steady. On the contrary, CGMs provide real-time information as well as the
context in which the information appears. The consistent application of CGM can
help to reduce the severity, frequency, and duration of hypoglycaemia as well
as reduces the risk of developing long-term diabetic complications. Setting the
low alert at a conservative level, the user can be notified of a pending low
before it happens, which helps in taking corrective measures promptly.
According to TechSci research report on “Global
Blood
Glucose Monitoring Devices Market, By Product Type (Self-Monitoring Glucose
Devices and Continuous Glucose Monitoring Devices), Self-Monitoring Glucose
Devices (Glucometers, Test Strips, Lancets), Continuous Glucose Monitoring
Devices (Sensors, Transmitters & receivers, Integrated Insulin Pumps), By
Application (Type 1 Diabetes, Type 2 Diabetes, Gestational Diabetes), By End
User (Home Care Settings, Hospital, Others), Forecast & Opportunities, 2026”, the global blood glucose monitoring devices is expected
to grow at a CAGR of 6.58% during the forecast period, owing to factors such as
rising prevalence of diabetes and other serious chronic diseases and increase
in geriatric population. Besides, technological advancements and new product
launches are fuelling the growth of blood glucose monitoring systems.
Overview: FreeStyle Libre System
When it comes to diabetes care and
management, accuracy is the key to identifying the patterns of a person's blood
glucose levels. Traditional glucose monitoring equipment requires daily
fingerstick calibrations, which can make it difficult for an individual to
stick to a diabetes management plan and may give rise to several complications.
The revolutionary FreeStyle Libre System introduced by Abbott is a continuous
glucose monitoring system that eliminates the need for daily blood glucose
testing and tracks patterns and trends in real-time. One-of-a-kind integrated
continuous glucose monitoring system takes the pain and inconvenience out of
glucose monitoring and enables the user to experience a better way of managing
the diabetes condition. Currently, more than 30 million Americans suffer from
diabetes and more than 400,000 people are using the accurate, consistent, and
FDA-approved FreeStyle Libre system for diabetes management.
The FreeStyle Libre System utilizes
sensors and advanced algorithms that provide real-time glucose readings for up
to 10 days, both day and night. The touch-screen readers can store the data for
up to 90-days, which allows users to track patterns and identify low-and
high-points of blood sugar levels over time. The retrieved data provide
actionable insights on trends and patterns, which can eventually help to manage
diabetes effectively.
What makes the FreeStyle Libre system stand out from its competitors?
·
Accuracy
With 14 days of unsurpassed accuracy,
the FreeStyle Libre 2 system measures glucose levels every minute, which is
five times more readings than other CGMs available in the market
currently.
The FreeStyle Libre systems have an
optional real-time glucose alarm that notifies when the glucose levels go too
high or too low. And the hi-tech system has one-third fewer false alarms
compared to other CGMs.
Enhancing focus on the need for
connectivity, the CGM system is designed to digitally connect and communicate
with other devices such as insulin pens and pumps for making self-medication
decisions.
The FreeStyle sensors are as small as
the size of two stacked quarters and the system can accurately determine
glucose levels even through clothing, which allows one to wear clothing of
their choice without intervening in the analysis of their glucose levels, the
device makes diabetes management more tolerable.
Unlike other CGMs that require the
device to be tucked on the prominent profile, FreeStyle allows the user to
stick up the system on the back of their arm. This helps to reduce the
embarrassment associated with the monitoring devices, especially among children
and teenagers.
- Better monitoring for Children
Parents can check glucose levels in
real-time which allows them to anticipate the interventions needed to be taken,
whether it is for providing glucose supplementation in the middle of the night,
or stop their child take a break from sports, etc.
The FreeStyle Libre technology makes
diabetes management accessible and affordable. Providing the unsurpassed levels
of accuracy, the FreeStyle Libre System cost is significantly less than other
CGMs.
The FreeStyle Libre system is the
longest-lasting CGM with a built-in shutoff at 14 days.
The data retrieved from the glucose
monitoring devices can be utilized to consider the factors responsible for
diabetes with a deeper understanding of glucose values. For 34 million
Americans living with diabetes, FDA clearance of the latest version of the
FreeStyle Libre system is not less than a life-changing experience. Globally,
more than 2 million people are using the FreeStyle Libre system for continuous
glucose monitoring.
Limitations of FreeStyle Libre Systems
·
FDA has not approved FreeStyle Libre Systems for pregnant women, individuals
on dialysis, or the critically ill population.
·
The FreeStyle Libre system consists of small parts, which can be
dangerous if swallowed.
·
Sensor placement can only be done at the back of the upper arm.
·
One must take standard precautions for transmission of bloodborne
pathogens.
·
Un safe for use on hypotensive, dehydrated, in shock,
hyperglycaemic-hyperosmolar state, neonates, with or without ketosis, or
critically ill patients.
·
When symptoms due to low or high blood glucose do not match, check sensor
glucose readings with a blood glucose meter to cross-check information.
·
Do not take high dosages of Vitamin C (>500 g) as this may falsely
raise sensor readings.
·
Failure to use the hi-tech system may result in missing a severely low
or high blood glucose event, which may trigger problems.
·
Remove the sensor before undergoing MRI, CT scan, X-ray, or diathermy
treatment.
Abbott FreeStyle Libre Products
FreeStyle Libre 2 System
The FreeStyle Libre 2 system is a
simple and easy-to-use real-time monitoring device, designed to improve patient
experience. The device features small and discreet sensor, which enhances its
wearability. For installation, a very thin filament of 0.4 mm is inserted 5 mm
beneath the skin to measure glucose level in interstitial fluid. The patients
can scan to their glucose level readings every 15 minutes, showcasing eight
hours of glucose history. The FreeStyle Libre 2 system can store up to 90 days
of glucose data, so the patients can see historic patterns. When readings cross
the customized levels, alarm triggers to aware the patient, and then he/she can
scan the sensor to see their glucose readings, but real-time glucose alarms do
not require scanning.
The FreeStyle Libre 2 system, FreeStyle
Libre 14-day system and FreeStyle Libre Pro system have almost
identical features. Here is a table to showcase the key difference among the
three Continuous Glucose Monitoring Systems by Abbott.
Comparing
Continuous Monitoring Glucose Systems
Dexcom G6
The Dexcom G6 is a continuous glucose
monitor that helps to manage diabetes-related health concerns. The device has
been approved for use for people aged 2 and above by FDA and is considered
ideal for people with diabetes who have often low or high blood sugar levels.
The device can offer insights into how certain foods, activities, and other
lifestyle habits influence blood sugar levels. Providing customizable alerts,
notifications, and data, the CGM device helps to monitor blood glucose levels.
The discreet design of Dexcom G6 prevents the device from getting caught on
clothing or interfering with physical activity.
Guardian Sensor 3
Guardian Sensor 3 CGM is integrated
with the latest advancement in insulin pump therapy, the Guardian Sensor 3,
that enables different levels of automation that fit every lifestyle. The
Sugar.IQ smart assistant works with Guardian Sensor 3 technology to improve
understanding of glucose patterns and the factors affecting them. The device
includes Exclusive Carelink Software, a web-based program that allows
generating reports to be used during doctor’s visits and to monitor one’s
progress. The device can be worn up to 7 days and each monthly box of sensors
includes 30 days of sensor wear to ensure reliability and accuracy of sensor glucose
values. The device can be either worn on the abdomen or under the arm.
Eversense
Implantable CGM
Eversense CGM system is the world’s
first long-term implantable CGM, whose sensor lasts for 90 days in the US and
180 days in Europe (FDA-approved). The device enables real-time tracking with a
smartphone app and on-body vibration alerts when blood sugar is high or low.
The water-resistant CGM system is chargeable and removable. The MARD (mean
absolute relative difference) compared to laboratory glucose value is just
below 9%, which makes the sensor one of the most accurate as compared to other
CGM devices. The silicone-based transmitter adhesive does not lead to skin
irritation. Also, replacing the transmitter does not lead to any loss of data.
Continuous Glucose
Monitoring System USA Market Overview
According to National Diabetics
Statistics Report 2020, around 10.5% of the USA population (34.2 million
people) have diabetes and around 34.5% of the US adult population (88 million
people) have prediabetes. The increasing prevalence of diabetes and wider
acceptance of advanced healthcare technologies are the main driving factors
contributing to the growth of continuous glucose monitoring (CGM) devices in
the United States. Major USA-based CGM-manufacturing companies such as Abbott
and Dexcom are leading the global Continuous Glucose Monitoring market. The
rising adoption of alternate and novel devices, as well as preventive measures
taken by the government, is also boosting the demand for CGMs for effective
understanding and management of the disease. A number of national organizations
in the United States are currently coordinating efforts to deliver type 2
diabetes prevention services to curb the economic and disabling psychological
effects of the disease.
With the advancement of healthcare
technologies and Artificial Intelligence, many companies are launching devices
which require less direct involvement of the patient in managing diabetes,
which is boosting the demand for CGM system in the USA. With the launch of
Abbott’s FreeStyle Libre CGM system, the sales grew 50% in the US in 2020. By
2021, Dexcom is planning to launch its G7 CGM system at the end of 2021, which
is expected to double the company’s revenue by 2025.
According to TechSci research report on “United States Wearable Medical Devices
Market By Type (Vital Signs Monitoring Devices
v/s Therapeutic Devices), By Product Type (Activity Monitors/Trackers,
Smartwatches, Patches, Smart Clothing), By Purpose (Heart rate, Blood Pressure,
Body Temperature, Blood oxygen saturation, Posture, Physical Activities,
Hearing Aids, Others), By Site (Handheld, Headband, Strap/Clip/Bracelet, Shoe
Sensors, Others), By Application (General Health & Fitness, Remote Patient
Monitoring, Home Healthcare), By Price Range (Economy, Medium, Premium), By
Distribution Channel (Store-Based v/s Non-Store-Based), By Business Segment
(B2B Vs B2C), By Region, Forecast & Opportunities, 2025”, the
United States wearable medical devices market is projected to grow at a
significant rate, owing to factors such as growing prevalence of chronic
diseases and increased need to focus on efficient and personalized monitoring
and patient care.
Conclusion
Continuous Glucose Monitoring Systems are
easy-to-use, reduces patient burden, lessens healthcare costs and improved
quality of life. In the recent years, diabetes tech space, including both
insulin pumps and CGMs have been gaining a momentum. The sudden outbreak of
coronavirus pandemic accelerated the growth as patients stayed out of the
hospital settings and heavily relied on virtual care, such as wearables. With
increasing number of target population across the globe and new product
launches, the CGM market growth is projected to be exponential.
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