FreeStyle Libre Flash | Diabetes Healthy Solutions

Non Invasive Glucose Meter Wins FDA Approval

Freestyle Libre ‘Flash’ Glucose Monitoring System.

The United States Food and Drug Administration (FDA) recently announced the long-awaited approval of Abbott Labs’ FreeStyle Libre Flash Glucose Monitoring System (Bloodless Glucose Meter). This is a meaningful development both for the company and for Diabetes patients, especially in the United States. However, it was expected. Abbott is already marketing this new noninvasive glucose meter and it was just a matter of time before the device received U.S. FDA approval.

When Can We Expect it in Major Retail Pharmacies?

Earlier this year, the company presented data from 50,000 Freestyle Libre users which show that patients are checking their blood sugar levels at least 16 times per day. This frequency is significantly higher compared to other monitoring systems. The high frequency of checking blood glucose levels is largely attributable to the fact that the FreeStyle Libre Flash Glucose Monitoring System does not require any finger pricking.

Since more frequent monitoring is usually associated with better health outcomes, particularly for diabetes patients, you can expect high demand for the device in the United States especially after winning FDA approval.

We expect the device to be launched in major pharmacies in the United States by the end of 2017. However, in the United States, FreeStyle Libre Flash is approved only for adults with diabetes. The FreeStyle Libre sensor can be considered a ‘replacement’ for fingersticks because it provides real-time readings and clear trends that are used for insulin dosing. Therefore, this device eliminates the need for any fingerstick calibrations.

In the United States, FreeStyle Libre Flash has three main differences:

A shorter wear time (10 days).
It will require a physician’s prescription.
A significantly longer warm-up period after installation (12 hours).

Outside the United States, the device does not require a prescription, has a longer wear time of 14 days, and requires just a 1-hour warm-up.

One of the biggest changes is the longer war-up period which means that when you insert a new sensor, it will not provide any real-time blood glucose readings for the first 12 hours. Therefore, some users must go back to fingersticks during the warm-up period. Therefore, it’s recommended that you put a new sensor on before bed in order to get through much of the warm-up period. The other option is to buy two readers, overlap sensor wear times in order to avoid going for 12 hours without glucose data.

FreeStyle Libre Flash is a Continuous Glucose Monitor because it collects glucose data every minute and displays the reading and trend arrow. However, it’s essential to understand that it does not have an alarm and it does not communicate continuously with the reader device as other Continuous Glucose Monitoring (CGM) devices do.

The sensor must be scanned within 1.5 inches using the hand-held reader to get real-time glucose data. You can scan the sensor even through clothing making the process far less painful, visible and obtrusive than a fingerstick.

Read about the Top 5 Companies Developing Non-Invasive Glucose Monitors in 2022!

FreeStyle libre Flash is approved to be worn on the upper arm, is fully disposable, is waterproof (for swimming and showering), is not affected by acetaminophen (Tylenol) and can store 8 hours of recent data. Remember, if more than 8 hours have passed between scans, the device will only capture the most recent 8 hours of data.

This approval comes one year after being submitted to the FDA for approval and a year since FreeStyle Libre Pro was launched in the US. This real-time version of FreeStyle Libre will expand the US Continuous Glucose Monitoring market significantly. The lower price, small on-body footprint, pharmacy distribution, no need for fingersticks, and ease of insertion are all very welcome improvements especially for diabetes patients.

FreeStyle Libre Flash is similar to convention CGM devices in that it measures the glucose levels in interstitial fluid in real time. However the device offers various advantages such as lower cost and longer sensor wear. Moreover in contrast to other CGM devices, FreeStyle Libre is factory calibrated meaning it doesn’t require fingerstick measurements for calibration.

New Information on Compatability with iPhone!

Editor’s Note: The FreeStyle LibreLink app and the LibreLinkUp are both now available from the app store for free download. the The LibreLink is compatible with the iPhone 7 and later versions and the LibreLinkUp has compatibility with iPad and iPhone. There’s no need to have the separate reader device.

Features of the FreeStyle LibreLink App

Pros:

Text-to-speech glucose readings. This is a very valuable feature for those who are visually impaired.
The app is now available in more than 24 countries and supported in 26 languages.
The option is available to make additional notes on insulin dosing, food, exercise and anything else relevant.
The app has the ability to log small insulin doses (of 0.1 units)

Cons:

You must have the app ‘open’ for it to scan – you can’t use it from the phone ‘lock’ screen
persons ages 4-17 must be supervised by a caregiver 18years or older.

Most people are excited to see this version of FreeStyle Libre Glucose Monitoring System coming to the United States. Diabetes patients globally have responded positively to this device and it’s now being used by at least 400,000 people in more than 41 countries.

More on Glucose monitoring on your phone!

List of FDA Approved Glucose Meters

In diabetes, the body loses its ability to produce insulin (blood sugar levels regulating hormone). This puts Type 1 and Type 2 diabetics at risk of either too low blood sugar levels (hypoglycemia) or too high blood glucose levels (hyperglycemia).

Both outcomes are undesired as they can easily lead to other complications such as blood circulation problems, kidney issues, and eye problems. Regular blood glucose monitoring is one of the main first-line defenses against the complications of diabetes.

The most widely practiced methods of monitoring blood glucose level are by using a lancet to prick a finger. However, due to the discomfort and pain associated with the process, blood glucose monitoring becomes a daunting process for many diabetes patients.

Needle-free and non-invasive methods of testing blood sugar levels are now being developed to help ease the burden for people living with diabetes. These methods may also prove to be cheaper particularly because patients can do away with buying disposable test strips and lancets. Non-invasive glucose monitoring systems make the process as painless and easy as possible in order to encourage diabetics to monitor their blood glucose levels as prescribed.

Non-invasive blood sugar monitors can also be linked with tablets and smartphones, making it easier to keep track of your blood glucose levels and trend through the day or even weeks. These automated measurements make it possible for people living with diabetes to get insight on why or when their blood glucose drops or rises.

How do blood glucose meters work?

Since 1970s scientists have been trying their level best to come up with non-invasive methods of detecting blood glucose levels .Today there are many promising methods in use, each with its advantages and shortcomings. The most common methods used include:

Using radio waves on the fingertips
Application of ultrasound waves that penetrate the skin
Measuring infrared radiation that the body emits
Measuring of the viscosity of fluids beneath the skin
Application of beam near-infrared energy to penetrate the skin

Although hundreds of millions of dollars’ have been spent in this research, no technology has been declared as an outstanding method in non-invasive glucose monitoring. Notably, further research is needed in improving the reliability and accuracy of these methods, manufacturers are tirelessly developing and marketing glucose monitors that are user-friendly.

Top Non-invasive Glucose Monitors Currently in the Market

If you are willing to buy a non-invasive glucose monitor, there are several varieties in the current market. However, your health is a sensitive issue; thus, take your time in making informed choices.

The first and most important guideline to narrow the selection list is by considering devices that have been approved by FDA. Since 2017 FDA has been reviewing and approving several devices and the list has been growing since then. These products need to get smarter, easier to use, and better to remain relevant in the thriving competition. As indicated in the list below.

FreeStyle Libre Flash

The FreeStyle Libre Flash holds an outstanding position for being the first non-invasive glucose monitoring device to be approved by the FDA. You need to install a sensor on the back of an upper arm before your start using FreeStyle Libre.

Notably, you have to this once per 2 weeks’ time or so and always remember to be extra careful with it, because it can rip off with a strong or a sudden force. However, this can be prevented by following detailed instructions in applying each sensor.

It’s usually a simple process that takes at most 2 minutes, which you can do on your own. The sensor is installed beneath the skin. It basically measures the quantity of glucose present in interstitial fluids, not in the blood. The sensor may take up to 15 minutes before measuring your actual blood glucose.

Pros

FreeStyle is affordable in the market
The included reader is easy use
Reading can be made using a smartphone app
Data obtained can be store for 8 hours
Data obtained can be illustrated on a time series graph

Cons

The sensor needs to be replaced with time
It’s not a long-term sustainable method

GlucoWatch G2 Biographer

FDA Approved Glucose Meters — GlucoWatch G2 Biographer

The GlucoWatch G2 Biographer is a Non-Invasive glucose Monitor device that has been approved by FDA. It’s basically a wristwatch that can make six measurements in an hour.

The device has an AutoSensor disposable upon use, usually attached to the Biographer’s back. This AutoSensor must contact the skin. A single AutoSensor can make 78 reading in total within 13 hours.

Upon installation, the AutoSensor require 2 hours to warm-up before making its first measurements. GlucoWatch uses electric currents to extract interstitial fluids within the skin.

Pros

Takes a short period of time to process data and display results
Rises alarm for low and high sugar levels upon programming
Appropriate in diabetics who need frequent glucose level test

Cons

Its accuracy is not fully assured by the FDA

EverSense CGM

EverSense is a non-invasive glucose monitoring device that offers Continuous Glucose Monitoring (CGM) properties. FDA approved it as the first CGM system.The EverSense CGM depends on a sensor implanted by a doctor beneath your skin. This means you have to undergo a minor operation to allow implantation. The device has a transmitter, over the sensor and above the skin, to allow data transmission. Users regard it as the best CGM in the market due to its accuracy.

Pros

Results can be scrutinized and reviewed via your smartphone
Rises alarms over high and low glucose levels
A sensor can last for 90 days upon implantation
Free from dangers of ripping off

Cons

In case the implantation site is infected, another implantation process is needed

Conclusion

Though there isn’t non-invasive glucose monitoring technology that stands out to be standard in the market, technology is evolving at a high rate. From implants that used to last for 14 days at most, currently, we have implants capable of lasting for several months.

It is possible for us to have a new non-glucose monitoring technology in the market- one that can function without being implanted beneath the skin.

For diabetics, new technology brings improvement in their health lives. With time, you might only be required to take a photograph of your eyes and a supercomputer to do the rest of the work.