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. 

 

• Real-time Monitoring

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.

 

• Connectivity

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. 

 

• Convenience

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. 

 

• Comfortable Experience

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.

 

• Cost-effective 

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.

 

• Durability

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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