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FreeStyle Libre (continuous glucose monitoring system)

Product
Developers: Abbott Laboratories
Last Release Date: 2021/06/24
Branches: Pharmaceuticals, Medicine, Healthcare

Content

Main article: Diabetes mellitus

How the FreeStyle Libre system works

To date, diabetes is incurable but effectively controlled. Until recently, diabetes control was associated with the need to constantly pierce the fingers in order to obtain glucose readings.

The FreeStyle Libre system, which is designed to free patients from the difficulties of glucose monitoring, does not require finger punctures.

The small round sensor continuously measures and automatically stores glucose readings day and night. Glucose readings are read using a painless 1-second scan, even through clothing. With each scan, you can see current glucose readings, glucose data from the last 8 hours, and a trend arrow showing the direction of glucose change.

The FreeStyle Libre system is waterproof and designed to be worn while showering, swimming and exercising.

The reports that the FreeStyle Libre system collects contain detailed information about glucose levels. This helps patients and physicians make informed decisions about diabetes control.

2023: Recall of 4 million defective glucometers

On April 3, 2023, the American Chemical and Pharmaceutical Corporation Abbott initiated a large-scale program to recall readers intended for use in conjunction with FreeStyle Libre systems for measuring glucose levels. In total, about 4.2 million devices distributed from November 2017 to February 2023 fall under the program.

The reader in question is a portable device that demonstrates glucose levels in real time, receiving readings from a special sensor mounted on the patient's shoulder. This allows you to quickly detect abnormalities in people with diabetes. Users can also use a compatible smartphone app to view glucose data.

Freestyle Libre handheld device that shows glucose levels in real time

The identified problem affects the FreeStyle Libre, FreeStyle Libre 14-day and FreeStyle Libre 2 systems. The readers for these products use rechargeable lithium-ion batteries, which can get very hot, spark or ignite when stored and charged incorrectly. The defect manifests itself when using USB cables and charging units from third-party manufacturers, as well as when the battery is damaged, exposed to liquids or when foreign particles get into the connectors.

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A USB cable and power adapter supplied by Abbott limits the current to safely charge the battery, while third-party accessories can provide much higher power, increasing the risk of fire. This can lead to serious injury or death, the US Food and Drug Administration (FDA) said in a notice.
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Abbott reports 206 incidents, including at least seven fires related to the problem described. One person was injured, but no deaths were recorded.[1]

2021: Introducing the Flash digital ecosystem

On June 24, 2021, Abbott introduced the FreeStyle Libre digital glucose monitoring ecosystem Flash: FreeStyle LibreLink apps, LibreLinkUp, and LibreView software that will enable real-time disease control for both patients and caregivers and physicians.

Image:FreeStyle Libre.jpg

FreeStyle LibreLink is the main application for FreeStyle Libre users. It activates the sensor and measures glucose levels. FreeStyle LibreLink displays current indicators of sugar status data , over the past 8 hours and the trend arrow. voice Reading the results is also available, setting up individual reminders and a timer that will work if the user does not measure glucose for more than eight hours. Another feature is the ability to add notes about food, insulin and other events.

LibreLinkUp allows family members and friends to monitor their loved ones' glucose levels with diabetes. Each time the sensor is scanned using a smartphone, the data is automatically sent to the LibreLinkUp application. This allows caregivers to monitor the condition of a loved one at any time of the day, even at a distance, and provide support if glucose levels rise or fall. Up to 20 people can connect to one FreeStyle LibreLink account.

In order to share reports on changes in glucose levels with the attending physician, it is no longer required to print or send it to. to mail The user can share data with a specialist using the LibreView platform, which is secure. cloudy storage The service makes it possible to form reports in an intuitive form, thanks to which the doctor can more easily and quickly identify the nature and dynamics of changes in indicators associated with the disease, and make a more informed decision on the management of the patient.

2019

Abbott, Medtronic, Sanofi and Novo Nordisk started sharing diabetic data

In mid-September 2019, Abbott and Medtronic announced data sharing agreements for digital diabetes care solutions. For example, Abbott is partnering with Sanofi to integrate glucose assessment and insulin delivery tools. And Medtronic is partnering with Novo Nordisk to use insulin dosing data from smart pen syringes in its glucose monitoring devices.

Abbott and Sanofi plan to develop a tool that could combine Abbott's FreeStyle Libre blood glucose monitoring app with insulin dosing information from Sanofi smart pens. At the same time, these applications and pen syringes will be processed by Sanofi cloud software, which is still in development. The creation of a digital ecosystem based on FreeStyle Libre is designed to make life easier for diabetics by optimizing the insulin delivery system for individual needs.

Abbott, Medtronic, Sanofi and Novo Nordisk announce data-sharing agreements for digital diabetes care solutions

Medtronic and Novo Nordisk, in turn, are ready to provide their users and their attending physicians with integrated data on both glucose monitoring and insulin dosages. It is assumed that insulin dosing data obtained from Novo Nordisk smart pens will be processed by the Medtronic continuous glucose monitoring device and transmitted back for dose adjustment. The combined system should help patients more effectively control blood glucose concentrations.

The president of the Medtronic branch, which deals with diabetes, believes that the future is behind the merger of data from different companies. Integrated analysis will allow a more conscious approach to diabetes management and make life easier for millions of patients.[2]

Increase in production by 5 times

At the end of June 2019 Abbott , Laboratories announced that it plans to increase production of the low-cost FreeStyle Libre continuous glucose monitoring device three to five times in the next three years due to an increase in the number of patients with. diabetes mellitus

Abbott executives said the increase in production of glucometers will begin in the second half of 2019 and will make it possible to prepare for the launch of FreeStyle Libre 2 in the United States. This next-generation device has been approved for sale in Europe and is under review in the US. While the Libre 2 comes with plenty of features, including sounding an alarm when sugar levels are dangerously reduced or increased, Abbott has no plans to raise the price of the device. This is possible thanks to the wide distribution of the brand - more than 1.5 million people use Libre glucometers.

Abbott increases production of cheap glucose meters by 5 times due to the increase in the number of diabetics

FreeStyle Libre was launched in Europe in 2014, and in the United States three years later. It allows people with diabetes to monitor their blood glucose levels without daily use of test strips. A sensor attached to the back of the shoulder measures glucose levels every minute. Users can check this value throughout the day by lifting a smartphone with an app installed to the sensor.

Abbott's main rivals, Medtronic and Dexcom, are critical of Libre's lack of automated alerts that can help diabetics monitor their condition. However, these companies are also taking steps to implement cheaper models to reach the poor.

Libre sales are expected to reach $1.5 billion in 2019. Earlier, Goldman Sachs analysts calculated that the global market for continuous glucose monitoring devices could reach $5 billion by 2021, compared with $3.7 billion in 2019, and Abbott will become the leader in sales in this sector.[3]

Integration with Novo Nordisk Insulin Pen

In mid-February 2019, Abbott Laboratories and Novo Nordisk partnered to provide integrated digital solutions for people with diabetes using insulin.

Cooperation will make it easy to exchange data between companies' devices. Thus, doses of insulin from reusable Novo Nordisk pen syringes will be automatically displayed in the cloud service and the Abbott FreeStyle Libre mobile application. This function will be provided by the NovoPen 6 and NovoPen Echo Plus pre-filled reusable pen syringe, which should hit the market in the first quarter of 2019.

Novo Nordisk syringe insulin doses are now automatically displayed in Abbott mobile app

The FreeStyle Libre system detects blood glucose concentrations with a sensor that can be worn on the back of the shoulder, eliminating the need for routine finger blood tests. Thanks to this device, the patient can determine his blood sugar level at any time and view the dynamics in real time on a smartphone. Typically, the app shows changes in glucose concentration over the past eight hours. The sensor and app are linked to LibreView, a secure cloud-based system for diabetes control that provides patients and healthcare professionals with clear and understandable reports from glucose monitoring devices.

The integration of Abbott and Novo Nordisk's two products will allow healthcare professionals, caregivers and people with diabetes to assess glucose concentration data and insulin doses administered in a timely manner. Matching these figures in real time will help patients and physicians make more informed treatment decisions and engage in a more meaningful and productive dialogue about its outcomes.

The companies promise to release their integrated technologies as soon as possible. Novo Nordisk plans to reach more than 50 countries with sales.[4]

Notes