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.

  1. FreeStyle Libre Flash

Freestyle Libre Flash Blood glucose monitoring systemThe 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
  1. 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
  1. EverSense CGM

EverSense CGMEverSense 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.

List of FDA Approved Glucose Meters

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Prestige Glucose Meter

The Prestige glucose meter provides an accurate and simple way to test blood glucose levels anywhere, anytime. Blood sugar testing is a vital part of controlling diabetes.

Research shows that keeping blood sugar levels within the recommended levels lowers the chance of developing diabetes-related complications such as blindness and kidney problems.

Regular testing lets diabetes patients know if their blood sugar is ‘too low’, ‘too high’ or ‘just right’ depending on what healthcare provider recommends for you.

Prestige Glucose Meter – Can also help if you are following a Keto Diet

Prestige Glucose Meter diabetesAlthough the prestige glucose meter requires more blood to get an accurate reading compared to other glucometers, it is important to note that this system is not just a plasma monitor. It is specifically designed to measure ‘whole blood’ glucose.

This is very important for people who want to keep their blood glucose levels within a very narrow range (70 to 100).  While the more common plasma glucose monitors are designed for diabetes patients who have extremely low (<50) or extremely high (>150) blood glucose readings, whole blood glucose monitors such as the Prestige glucose meter are particularly useful for non-diabetics whose blood glucose level is either in the normal (80-100) range or hypoglycemics (~50 range) who want to know the accurate amount of sugar in the blood.

This system is also beneficial for people who are on the ketogenic diet (blood glucose levels must be maintained within the 60-80 range).

Plasma glucometers are most accurate when the blood glucose is usually extremely low, requiring medical attention or extremely high, requiring patients to use insulin. Therefore, plasma glucose meters do not help non-diabetics particularly because they don’t provide accurate readings for the 50-100 range.

While plasma glucometers work well for people who are diabetic they are not useful for those who are non-diabetic. However, whole blood glucose monitors such as the Prestige glucose monitor meet this need.

Therefore it’s important to note that:

  • People who are diabetic most likely prefer plasma glucose monitors but the Prestige glucose meter can also be used by diabetics
  • Non-diabetics may want to try whole blood glucose monitors such as the Prestige glucose monitor

Key features of the Prestige Glucose Meter.

  • Fast and accurate
  • Provides the date and time for each test
  • 14 and 30-day averaging
  • Large and easy to read display
  • Tests in 3 simple steps
  • Large, easy-to-read digital display
  • Uploading capability
  • Fast and accurate results
  • One-button coding
  • Compatible with prestige blood glucose test strips

Package contents

  • Prestige Blood Glucose Meter with AA batteries installed
  • Self-test log book
  • Compact case
  • Owners booklet
  • Quick reference guide

Product details

  • Brand: Nipro Diagnostics
  • Dimensions: 2″ x 3″ x 2″
  • Weight: 0.53125 lbs

Meter options

The Prestige blood glucose meter has the following wonderful options that can be easily customized to the user’s needs:

  • Test results as whole blood

Whole blood refers to blood that is obtained directly from the finger. Users should always use whole blood when testing with the Prestige glucose monitor.

  • Test results as plasma

Plasma, one of the key components of blood, is used by most laboratories for testing. However, it’s important to note that plasma glucose results are about 12% higher than results from whole blood. When using this option, the glucometer uses the whole blood value to determine and display the result. However, plasma should never be used for testing with this system.

  • Mg/dL (milligrams per deciliter)

This is a glucose unit of measure that is commonly used in the United States.

  • Mmol/L (millimoles per liter)

This is a glucose unit of measure that is used in some countries outside the United States. When using this options users should either choose Per (Period: 6.1 mmol/L) or Com (6,1 mmol/L).

  • Avg=14d

This option displays the average results for the last 14 days

  • Avg=30d

This option displays the average results for the last 30 days

  • 12 hr

Time based on am/pm (12 hour clock system)

  • 24 hr

Time based on the 12 hour clock system

The prestige glucose meter is an excellent glucose monitor that offers a wide range of great additions. It features a large easy-to-read screen for people who have bad eye sight as well as children. Moreover, it uses Prestige smart test strips and offers accurate blood glucose test results, unlike many other glucometers on the market.

So, talk to your doctor and diabetes supplier about using the Prestige glucose meter.

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The Ascensia Elite Glucose Meter

The Ascenisa Elite Glucose Meter is a new glucometer on the market that features a small and compact design. The lancets and test strips are stored in the same little pouch that can be easily stowed in a purse or pocket for easy travelling.

The Ascenisa Elite Glucometer is a miniature compared to the glucose meters that were considered the best on the market just a few years ago. Technological advancements have made this glucometer so small yet very powerful and fast.

Ascensia elite Glucose MeterOne of the main advantages of the Ascenisa glucose meter that have made it so popular is that it takes a very small amount of blood to provide accurate glucose level readings in just a few seconds. Less blood means that the lancets used are thinner and users experience minimal discomfort. Moreover, the Ascenisa Elite Meter is very fast.

A few years ago, the best glucose meters on the market used to take at least a minute to read the blood glucose. However, now it’s possible to have accurate glucose readings in a matter of seconds, in fact experienced users can accomplish the entire process in less than a minute, including cleaning the fingertip, checking blood glucose, and putting on a band-aid.

In days past, diabetics on the go had to carry a booklet to record glucose readings. However, modern glucose monitors feature built-in memories for storing up to 100 readings, making it easy for diabetics to track and observe trends of their glucose levels wherever they go.

Therefore, newly diagnosed diabetics who are about to buy their first glucose meters or diabetics who are thinking of getting a new glucose meter, this new breed of quick, tiny and almost painless devices like the Ascenisa Elite Glucometer can make the process of tracking their glucose less of a hassle.

Key features of the new Ascenisa Elite Glucose meter

  • Professionally recommended
  • Offers confidence and security
  • Proven reliability and accuracy
  • One button memory for easy PC download

Bloodless glucose meter Pros

  • The one button access allows users to access up to 100 tests
  • No button testing
  • No cleaning or wiping
  • Requires a very small blood sample of only 2 micro liters
  • Cleared for multiple site testing
  • Serum Plasma Referenced
  • Touchable Ascenisa Elite blood glucose test strips
  • Features automatic strip filling action
  • Less pain

Bloodless glucose monitor appCons

  • This glucometer cannot hold a large number of test results (holds up to 100 tests)

What is included in the test kit?

  • XL blood glucose meter
  • Check strip
  • 5 test strips
  • Normal control
  • Automatic lancing device
  • 5 lancets
  • Record diary
  • User manual
  • Carrying guide

Statistics for Ascensia Elite Glucose Meter

  • Requires a very small sample compared to other glucometers on the market
  • Lower overall costs for blood glucose level testing because the testing strips are significantly less expensive than other brands
  • Holds up to 100 tests
  • Testing strips are designed to draw blood directly into the strip creating anxiety relief and a sense of convenience to patients
  • Unit is automatically activated once the test strip is correctly inserted
  • Compatible with Glucofacts PC software
  • Provides a 30 and 14-day average for easy comparison

The Ascenisa Elite Glucose Meter has gained immense popularity largely because it is designed as ‘no-frilled’. Users don’t have to sort through any menu options or endure complicated procedures prior to testing.

The unit turns on automatically once you insert the testing strip. After administering the lance, you simply allow the Ascensia testing strip to extract the amount of blood needed for testing.

The low cost of Ascensia elite testing supplies makes it a very popular model. Moreover, this glucometer is approved for testing on multiple sites, making it appealing to many users, including people who have sensitive hands.

Bottom line

Although there are other glucometers that feature additional features that can be helpful to users, the Ascenisa Elite Glucose Meter has been proven to be remarkably reliable and accurate in testing. Moreover, the low cost of operation makes this unit worth considering especially if money is a major consideration.

For people who have children who are diabetic, this unit may be a solid option mainly because it’s easy to operate and less expensive to replace.

Moreover, the Ascenisa Elite Glucose Meter allows for multiple site testing so the fingers or hands will not always be a primary requirement for accurate testing. The sip-in sample testing makes this unit virtually error-proof for taking accurate blood tests.

Read about diabetic watches HERE!

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The Precision Pro Glucose Meter

The Precision Pro Blood Glucose and Ketone Monitoring System is designed for outside the body (in vitro) diagnostic use for measurement of D-glucose and ketone in capillary blood samples. The Precision Pro System is not designed to diagnose diabetes, but is rather meant for professional use and as an aid in determining and monitoring the effectiveness of various diabetes management programs.

Features of the Precision Pro Monitoring System:

  • Tests blood ketone and blood glucose levels all with the same system, using the Precision blood ketone test strips and Precision blood glucose test strips.
  • Simple icon-driving menu helps simplify blood sugar monitoring
  • Intuitive and simple set-up
  • Easy-to-view results
  • Offers the ability to easily scroll back and forth
  • No coding required
  • The test strips are neatly wrapped in foil to help prevent errors as a result of contamination

the precision glucose meterKey features and specifications – Precision Pro Glucose Meter

  • Easy data entry

Precision Pro Blood Glucose System allows you to choose between the alphanumeric keypad and built-in barcode scanner for data entry according to point-of-care policy. The system can be easily configured to accept operator identification, patient identification, comment code, test strip lot number and two text fields.

  • Patient ID Confirmation

The system can display useful information about the patient such as the patients name, gender, date of birth, and supporting patient identification procedure. For confirmation, the system can require entry of the patient’s year of birth.

  • Data integrity

Precision Pro Blood Glucose meter offers many options to ensure that accurate data is collected. These include specifying the maximum and minimum length of the ID, verifying the barcode, restricting the number of barcodes that can be accepted. The system can also require repeated data entry on the keypad especially when you’re not using the barcode scanner.  The system also keeps a record of the operator and patient data entry method (manual versus scanned) co help in identification and correction of errors.

  • Fast, simple testing

To perform tests on the system, you simply need to insert the test strip into the port, apply the sample and wait for results to be displayed. For convenience, the sample can be applied to either the end or top of test strips. The test only starts when the sample applied is adequate. This safeguard is meant to strip wastage, prevent errors, and unnecessary repeat tests.

  • Automatic calibration

You can automatically calibrate the system by simply scanning the barcode on test strips before use. This also allows the system to check the expiry date to ensure accurate and reliable test results.

  • QC Lock-out

Users can configure the system to require periodic testing and lock out the systems if tests are not performed using control solutions or if the tests are incomplete. QC tests results are usually displayed as pass or fail only in order to prevent testing while the system is in control test mode.

  • Operator management

Access to the system can be restricted to authorized or certified operators in order to prevent use by untrained users.

  • Result Storage

The Precision Pro Blood Glucose and Ketone Monitoring System can store up to 1,000 control test results and 2,500 patient test results. It can also store 2 linearity panels and up to 20 proficiency test results. Moreover, users can automatically upload all stored data to the data management system. This requires an upload cable (optional), docking station (optional), or wirelessly in WiFi (optional) enabled facilities.

  • Network connectivity

The system can easily upload data wirelessly, via a docking station or cable. This offers an automated and simple way to manage multiple systems.

System components

The Precision Pro Blood Glucose Meter includes the following components:

  • MeterPrecision Pro Monitoring System
  • Control solutions
  • Blood glucose test strips

Optional components for use with the system

  • Blood ketone test strips  
  • Calibration verification controls
  • Abbot single use lancet
  • Docking station
  • Data management system
  • Carry case
  • FreeStyle isolation bags
  • Wireless set-up utility
  • Data upload cable

In addition to being used by patients to monitor their blood sugar level and the effectiveness of their diabetes management systems, Precision Pro Blood Glucose and Ketone Monitoring System can also be used by doctors and other health care professionals. It is ideal for quantitative measurement of glucose in arterial, neonatal or venous whole blood ketone and blood sugar levels.

However, the sample should be used within 30 minutes upon collection. Precision Pro Blood Glucose Monitoring System is designed to help simplify point-of-care testing for doctors, nurses and other healthcare professionals. It provides features that improve the reliability and efficiency of the testing process.

Read about the non invasive glucose meter HERE!

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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.

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