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 Adhesive patchFreeStyle 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.

Non invasive glucose meterThis 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!

continuous glucose monitoring appsEditor’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

Bloodless glucose meter

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)

Bloodless glucose monitor app

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!

Normal blood glucose levels

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The Bloodless Glucose Meter

If you are a diabetic and sick and tired of sore fingers and the pain associated with sticking your fingers every time you need to check your blood sugar, the ‘up and coming’ bloodless glucose meter may be just what you need! These sought after meters will very soon be available, in styles like the glucowatch, which is designed to be worn on the wrist.

How Does the Bloodless Glucose Meter Work?

Diabetic Watch GlucowatchThese particular meters work by drawing interstitial fluid through the sweat glands in the skin by using a small electric current. This electric current is so small that the only real discomfort associated with using the device is some possible irritation caused by wearing the device around the wrist or arm, and this is usually no more uncomfortable than wearing a large watch or MP3 player. The bloodless glucose monitor lives up to its name in that it is completely pain-free for most users and represents the newest and best in glucose monitoring technology.

 The meters of today are useful tools when it comes to tracking and trending blood glucose levels, especially over a long period of time such as twelve hours. By using the bloodless glucose meter you can have a reading every 20 minutes for up to a 12 hour period and as many as four thousand readings can be stored in memory and viewed at the touch of a button. The bloodless bloodless glucose meterglucose meter can also be set to alert you if your blood sugar gets too high or too low.

Azurite: Developing the Bloodless Glucose Meter          

Azurite is a biotech company that is based in San Francisco and was co-founded by Laura Andrews and Kelly Zebrowski. The main aim of this biotech company is to build a non invasive, (or  bloodless glucose monitor).

A New approach to Non Invasive Glucose Testing.                            

Although this goal is quite familiar, Azurite has taken a different and unique approach where the blood glucose level will be measured through an EM (electromagnetic) sensing system. Therefore, the idea is mainly based on the fact that electromagnetic signals bounce off surfaces and return to the source with a pattern that reflects the surface they have encountered.

Just like any other molecules, glucose molecules reflect unique electromagnetic signals based on their electrical properties. Therefore, Azurite also hopes to bounce electromagnetic signals off the glucose molecules in your blood which will return to the device for an interpretation of how much glucose they have encountered.

There are various research groups that have ascertained the blood glucose level successfully by simply observing electrical properties of blood glucose. Moreover, researchers from the University of Missisipi have demonstrated that a micro-strip patch antenna can help determine the blood glucose levels by measuring the electrical properties of the sample. Azurite has drawn from this research and works of other research groups that have examined electrical properties of blood glucose.

Azurite has modeled a fresh approach that will hopefully lead to a non invasive glucose monitoring device that uses electromagnetic technology to measure electrical properties remotely. Moreover the company is determined to make an impact on diabetics by creating a device that combines convenience and the rich data of accurate continuous testing.

Newest Technologies for Bloodless Glucose Meter                            

Arriva glucose meterAlthough there are various technologies being used to develop non invasive testing devices including florescent technology, electromagnetic sensing, mid-infrared spectroscopy and ultrasound technology among other technologies, not all have received FDA approval yet. However, the GlucoTrack has already received the CE Mark approval for use in the EU (European Union).

This type of technology is brand new, but definitely does have a secure place in the proper management of diabetes.

 

Read on here for more info on the bloodless glucose meter.

bloodless glucose meter

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