Glucose meter devices: Review

Name: Alemu Abibi Mekonen (Msc, Biomedical

Engineering)

November: 2018
Table of Contents
Abstract.......................................................................................................................................................2
Historical technology of Glucose meter devices..........................................................................................3
Glucose Biosensors meter........................................................................................................................3
1st generation glucose biosensors............................................................................................................3
2nd generation of glucose meter..............................................................................................................3
3rd generation glucose Biosensor meter..................................................................................................4
The Future of Non_invasive Glucose Monitoring...................................................................................4
Types of glucose meter Devices..................................................................................................................4
Self-monitoring glucose meter.................................................................................................................4
Continuous Glucose Monitors devices (CGMs)......................................................................................5
Non_invasive Glucose Monitor...............................................................................................................5
List of Glucose meter device.......................................................................................................................6
ACCu-check aviva plus/Performa...........................................................................................................7
Freestyle glucose meter...........................................................................................................................7
Bayer_contour_next USB........................................................................................................................7
OneTouch verio IQ..................................................................................................................................8
Telecare Blood glucose meter (BGM)....................................................................................................8
True truck Blood glucose meter...............................................................................................................8
Reference...................................................................................................................................................10

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
Abstract

Glucose meter devices have one of the diagnostics devices for diabetics patient and prevent from
diabetic complication in kidney damage, heart disease, eye damage and lower extremes
amputation. Glucose meter have great improvements for healthcare system that mostly
manufactured in house use, friendly use, simple and easy operation.
Now a day glucose meter available self_monitoring glucose meter, continuous monitoring (real
time) glucose meter and non-invasive glucose meter which without prick the tip patient of the
finger. The self-monitoring, continuous and noninvasive glucose meter have avial in the marks in
dfferent form of model for diabetic patients.
Some of the glucose meter that available in the market and FDA approved glucose ACCu-check
aviva , freestyle light, one touch verio IQ, Bayer counter next USB, Telecare and True_track
blood glucose meter which is easily and simple our life.
Glucose measurement technique and method of detection is can be Amprometric,
Potentiometric, Reflectance photometer and Coilorometric method for produced the current and
potential which is processing by the electronics transducers for determine the glucose level in
digital and qualitatively in readable form.
The glucose meter device also with test strips combined or integrated with bio-receptors
(enzyme, mediator) GDH- PQQ, FAD-GDH, GDH-NAD which identify the specific substance
of glucose and others within the three electrode system (Working, Auxiliary and reference
electrode).
Generally, This paper provides a brief note enlightening the important points of Glucose meter
devices in generation, detection method, enzyme use, features and the most approved in FDA.

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
 Historical technology of Glucose meter devices

Glucose Biosensors meter

Glucose Biosensor meter is a device integrating and combining with a biological element ability
to detect a physical, biological or chemical property of the analyte (blood sample) and have an
electronic components which is the electronic transducer converts and translates the reaction
with bio-receptors and the analyte (blood sample) into a electrical signal which is easily
measured level of glucose. The Biosensors which the biological element is nucleic acid,
antibodies, cell receptors, enzymes, organelles , microorganisms, tissue and natural products.

1st generation of glucose biosensors

The 1st glucose biosensors technology was launched by the

company “Yellow spring Instrument company” for the
measurement of glucose level in 1975. The glucose react
with glucose oxidase and it’s changed into the product of
“gluconolactone” and “hydrogen peroxide” and then the
Hydrogen peroxide diffuse on the working electrode to have
reduction and oxidation reaction to liberate oxygen and 2
electron. The concentration of blood glucose is proportional
to the hydrogen/oxide that liberate the electron. This devices
have it’s own drawback which is oxidizing other anayte due
to high operating potential and oxygen fluctuation in the
blood sample

2nd generation of glucose meter

The 2nd generation glucose biosensors develop due to the

first generation drawback to eliminated oxidizing other
analyte using lower operation potential and the variation of
oxygen in the analyte or sample. The 2nd generation of
glucose meter use mediator either oxidizing and reduced
form instead of oxygen in the first generation glucose meter
to reduced and eliminated the drawback of insufficient and
limited oxygen amount in the sample. This glucose
biosensor use different of reduction or oxidation mediators
such as ferricyanide , quinines, ferrocene, , methylene blue
etc. The second geberation have also its own drawbacks
high completion between mediator and oxygen,interference
of other electroactive analyet

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
3rd generation glucose Biosensor meter

The 3rd generation glucose biosensors develop by the

special technology Carbon nanotubes immobilization to the
of working surface electrode provide appropriate
coordination for redox (reduction and oxidation) enzyme
immobilization and create connection between the three
electrode system surface.This biosensors contains carbon
nanotube specialized design electrode system and the
electron direct transfer between the active center of enzyme
and the working electrode without any mediators.

The Future of Noninvasive Glucose Monitoring

This device uses light to measure the level of glucose

without blood and pricks the tip of finger it emit an infrared
light. The future glucose meter contact with specific place
that want to be measure the level of glucose in fingertip,
forearm, palm other place that the devices sent the special
light to the body by reflected with information to the
devices, which calculated and display the level of glucose in
digital in qualitatively. The noninvasive devices still being
under develop and clinical trial requires for further clinical
studies yet not approved by FDA.

Types of glucose_meter Devices

Self_monitoring glucose meter

Self_monitoring glucose meter is one of the analytical device for monitoring the level of glucose
in our blood. This device is easily operated and friendly use for the patient or normal people
without the help of the physicians and due to this Now a day people lived in the developing
country use handheld and homemade self-monitoring glucose meter to prevent them self from
chronic disease and daily checked before and after the meal and monitor them self.
Self-monitoring glucose meters are the standard type of glucose meter devices and With these
meters easily take blood sample from the tip of the finger by yourself to the test strip and within
a seconds, the device detects and analyze level of glucose in the sample of the blood and it’s
provides glucose level in quantitatively. The self-monitoring glucose meter have relatively
cheap, portable handheld, friendly operation simple and easily use, quick results, sensitive and
reliability.

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
Continuous_Glucose Monitors (CGMs)

Continuous Glucose Monitors is devices that implanted in the area where to be monitor and
measure glucose level in real-time continuously to prevent the patient from diabetic
complications . This devices have tiny electrode sensors called a glucose bio-sensor into the skin
of interstitial fluid to measure the level of glucose in tissue fluid. This devices connected with
wireless a transmitter device that sends the data of information regarding to the glucose level to a
monitoring and controlling the glucose level.
Continuous glucose monitoring detect and provides information about the level of glucose in the
blood and including immediate real-time updated information display of glucose level and send
message wireless to device in readable format to the users the alerts and alarms. This devices
progressively more accurate, sensitive, reliable, small, comfortable, user-friendly and connect to
wireless to share information to inform, motivate, educate, alarm and alert the diabetic patient.
Continuous Glucose Monitors are currently in use can be - a continuous subcutaneous glucose
monitor (CSGM) and a continuous_blood glucose monitor (CBGM). Due to the tip of glucose
sensor surface contamination of the electrode by proteins, fatty, thickening or coagulation factors
and the risk of thromboembolism, most of the Continuous_Glucose Monitors, don’t measure
blood glucose level with direct. Therefore to avoid the overcome above problem,
subcutaneously implantable tiny glucose sensor needle-type electrodes measuring glucose level
of concentrations in interstitial fluid. This devices have an advantages for they take reading all
day, provides big picture of glucose level and not required test strips.

Non_invasive Glucose Monitor

Non_invasive glucose meter devices is future and latest technology for glucose monitoring and a
sensor technology design and manufacture on the optical approaches for the measurement of
glucose level without prick finger and with the enzyme and mediators. One of the most non-
invasive meter will be the optical glucose monitoring devices use that apply the principle of
light reflectance, transmittance and adsorption in the skin that directly send the light and back
with the information from interstitial fluid, anterior chamber of eye and other parts for
measurement of glucose level.
The new generation of diabetes management that combines real-time interactive glucose level
control with high accuracy blood droplet free testing we all know diabetics are currently required
to prick a finger and draw blood a painful regimen especially for elderly patients and children
and one that consistently produces totally inaccurate results to solves this problem once and for
all can you imagine a world where our diabetic friends and family never have to prick their
finger again in fact never have to handle test strips at all or carry around lancets. This devices
have proprietary cartridge with 20 sensors into the meter and it automatically connects to the

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
cloud greets the user and displays the results of the last test then with one button ease of use hold
to your skin and press start the test is performed by a self-contained pet vax sensor module
requiring no blood droplet or a separate lancet device producing a virtually painless test in less
than three seconds and it’s has transmit the data to your physician with continued use the system
will be seamlessly gathering critical data connecting clinicians with patients and empowering
diabetics to better understand and it enables clinicians who can intervene in a patient's health
management to monitor this vital parameter information for an office visit or worse
hospitalization this allows physicians manage patient more effectively. These products in order
to test glucose levels this technology replaces all of these revolutionary lancing sensor
technology penetrates the skin to a sufficient depth automatically taking its reading while still in
the tissue diabetic in a single use snap in cartridge combined with the latest and wireless
communications. This devices no need skin pricks, blood sample and test strips.

List of Glucose meter device

Glucose meter devices, Here I have mentioned the most popular in the market and it’s have an
approval from American food and drug administrators FDA.
 Amprometric method : one of the method or Technology for the measurement glucose
concentration based on the small current changed that produced from the bio-receptor
and the analyte , which amplified and processed by the electronic devices and displayed
in quantitatively for the reader
 Potentiometric method: the same as Apreometic methode , the only difference is that
apply the potential across the three electrode system to facilitate the reaction between
the bio-receptor and the analyte due to this measure the small potential across the
working and Auxiliary electrode.
 Reflectance photometer and Coilorometric methode : based on the reflectance and the
coulure changed between the bio-receptors and anaylte and after such phenomena appear
measure the level of glucose due to potential or current.
 GDH- PQQ: This is an enzyme/cofactor incorporated or integrated on the test strips test
GDH-PQQ (Glucose Dehydrogenase PyrroloQuinoline Quinone)
 FAD-GDH: Ezyme/cofactors found on the glucose test strips “Glucose Dehydrogenase-
Flavin Adenine Dinucleotide”.
 GDH-NAD : Enzyme/cofactors Glucose Dehydrogenase Nicotinamide_Adenine_Di-
nucleotide (for low potential)

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
ACCu-check aviva plus/Performa

The technology of Accu_chek Blood glucose meter develop by using an enzyme called Glucose
dehydrogenase pyrroloquinolnequinone – GDH-PQQ on the test strips electrodes. The mediator/enzyme
converts the glucose on the test strips electrode into the gluconolactone as the product and the mediator of
oxidized form of hexacyanoferrate converts into the reduced of the mediator hexacyanoferrate that reduced
on the working electrode surface to liberate the electron this electron will processed and record for determine
the glucose. These small electron produce is recoded and amplified by the transducers which proportional to
the sample blood glucose. This devices have backlit display automatic eject of the blood, audio capability,
Performance in low or high temperatures, Memory, Size and handling and it can also send the data wirelessly Accu-Chek Aviva Plus blood
to the handheld mobile phone or smart phone. glucose meter

Freestyle glucose meter

The technology used in the Freestyle glucose meter is the colorimetric biosensors colorimetric biosensor
method for determine the level of glucose. This have devices have an enzyme which recognize the glucose
present in the blood of sample during react with HDH-FAD amperostatic coulometers on the working
electrode surface for transfer electron. The electron which produced from the reaction directly proportional to
the concentration of the blood glucose in the sample. The devices is perfectly design for handheld, small,
easily operation, friendly use and with backlight , memory, time, date and store up to 400 test results. This
devices sold alone with out the test strips but its available in the market.

Bayer contour next USB

This is self-monitoring analytical glucose meter which is used to monitoring and utilizing by diabetic patient
at home for measuring the levele of glucose qualitatively and its used by only single patient for prevent
transition of any blood contamination disease. The Bayer_Contour next USB the technological principle used
for measuring the level of glucose is an amperometric principle which is used an enzyme called GDH-FAD,
which found on the test strips reacts with sample of analyte of undergoing reduction and oxidation reaction
and then it produces the electron due to this redox (reduction and oxidation) reaction which is connect with the
electrode system (working, reference, and Auxiliary electrode) and processed with electronica transduces for
converting and processing the signal into readable form.

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
OneTouch verio IQ

The one_touch verio IQ is one of the self-monitoring glucose meter its working principle by amperometic
measurement using current generated by the reaction of an enzyme GDH-FAD
(Flavin_Adenine_dinucleotide-glucose_dehydrogenase) and sample of the blood which are undergoing
oxidation and redaction reaction due to this reaction they produce current and measured by the transducers
and coveted in electrical form for readable form. The one touch verio IQ glucose meter used for
measurement of qualitatively of glucose level blood that draw from the one of the our body parts such as
finger, forearm and used by only for single patient for avoiding any contamination. This devices used for
in_vitro diagnostic at home or hospital as well.

Telecare Blood glucose meter (BGM)

The Telecare Blood glucose meter (BGM) is the 1 st smartphone or cellular enabled and connected glucose
meter approved by America food and drug administrator FDA, that motivates, manage and enables the
peoples lived with diabetics patients and the technology send the data to local server which is privately
secure and accessed by the families , nurse, and doctors for better manage the child, elders and their families.
The Telecare blood glucose meter like just like normal blood glucose meter but it connected and embeds to
the cellular phone that transmit the blood glucose date to the Teccare server and it creates quick and
immediate response in two-way connect feedback from the caregiver and the patient to have better health
management system. The care giver Nurse, doctors and other stockholder can look up the received data and
the telecare devices also respond directly by the electronic health records

True truck Blood glucose meter

The working technology on the electrochemical biosensors Potentiometric measurement which caused the
redaction and oxidation reaction of an enzyme found on the test strips of electrode and the blood react with
the glucose produce gluconolactone and potassium ferrocynaide (mediator) as the product. The potassium
ferrocynaide oxidized on the surface of working electrode when apply the potential across the Auxiliary
electrode and working to liberate the electron that the electron produce from this reaction received by the
transducer to convert into electrical signal and it proportional to the glucose on the blood sample

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
Manufa Name of Technology Testing Calibr Temperat Batter Cost Enzyme/ Measured Measureme Hemat Referen
cturer glucose meter /Detection Time ation ure y in Cofactor nt Range ocrit ce
method per Depende dollar use mg/dL Range
Sample nt in (%)
Size
Telcare TELCARE amperometr 5 sec/ Autoc 10ºC to 3-volt $149. glucose Capillary 20-600 30-55 [1][18]
Incorpo BGM ic 0.8ul oding 40º C Li 95 oxidase whole blood
rated glucose
Abbott Freestyle Amperomet 5sec Autom 40 to 3-volt $49.9 GDH- Capillary 20 to 500 15 to [17][4]
Diabete insulinx ric /0.3uL atic 104o Li 9 FAD whole blood 65
s Care F glucose
Inc. Freestyle coulometric 5 sec/0.3 None 4 to 40°C 3-volt $19.9 GDH- Whole blood 20-500 15-65 [4][8]
Freedom uL require Li 9 FAD glucose
d
Freestyle Amperomet 5 sec/0.6 no 59o AAA $24.9 GDH- Capillary 20-500 30-60 [2] [4]
Precision Xtra ric method uL calibra -104 o (2) 9 NAD whole blood
tion F
Bayer Contour next Amperomet 5 sec/ no (5 3-volt $19.9 FAD- Capillary 20-600 15-65 [4][10]
USB ric method 0.6 uL calibra oC to Li (2) 9 GDH whole blood
tion 45oC glucose
Home True Track Potentiomet 10 sec/1 Check 50°F - CR $36.7 glucose Blood glucose 20 – 600 30 – [3] [4]
Diagno ric method uL strip 104°F 2032 7 oxidase 55
stics (1)
LifeSca OneTouch® Amperomet 5 sec/ 1 Check 40°F- 3-volt $23.1 Glucose Capillary 20 - 600 30 - 55 [11][4]
n, Inc. Ultra®2 ric µL strip 86°F. Li 6 Oxidase whole blood
glucose
OneTouch® Reflectance5 sec/1 Check 43–111°F AAA $60.0 glucose Capillary 1.1 to 33.3 30-55 [16][4]
UltraSmart® photometer uL strip (2) 0 oxidase blood glucose mmol/L
OneTouch Amperometi 5 s / No 41-86 oF (AA $73.3 GDH- Capillary 20-600 20 – [4][9]
verio IQ c 0.4µL require A)(2) 8 FAD whole blood 60
glucose
Roche Accu-Chek amperometr 5 sec/0.6 Code (57 to 3-volt $92.5 GDH- Capillary 20 – 600 10 to [5][4]
Aviva ic uL Key 100ºF Li (1) 1 PQQ whole blood 65
glucose

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
Accu-Chek amperometr 5 sec/1.5 Autom 53.6 - AAA $70.5 GDH- Capillary 20 - 580 30-55 [12][4]
Compact Plus ic uL atic 104° F ( (2) 0 PQQ whole blood
Glucose

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering
 Reference
1. https://www.thediabetescouncil.com/10-popular-blood-glucose-meters-put-to-the-test/
2. https://www.accessdata.fda.gov/cdrh_docs/reviews/K130094.pdf
3. https://www.accessdata.fda.gov/cdrh_docs/reviews/K032657.pdf
4. http://main.diabetes.org/dforg/pdfs/2017/2017-cg-blood-glucose-meters.pdf
5. https://www.accessdata.fda.gov/cdrh_docs/reviews/K070585.pdf
6. https://type2diabetes.com/living-with-t2d/types-of-blood-glucose-meters/
7. https://www.healthline.com/health/type-2-diabetes/choosing-glucose-meter#outlook
8. https://www.accessdata.fda.gov/cdrh_docs/reviews/K092602.pdf
9. https://www.accessdata.fda.gov/cdrh_docs/reviews/K110637.pdf
10. https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150942.pdf
11. https://www.accessdata.fda.gov/cdrh_docs/reviews/K103542.pdf
12. https://www.accessdata.fda.gov/cdrh_docs/reviews/K113614.pdf
13. https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/
glucosetestingdevices/default.htm
14. https://www.accessdata.fda.gov/cdrh_docs/reviews/K131366.pdd
15. https://www.accessdata.fda.gov/cdrh_docs/reviews/K113614
16. https://www.accessdata.fda.gov/cdrh_docs/reviews/K043197.pdf
17. https://www.accessdata.fda.gov/cdrh_docs/reviews/K111874.pdf
18. https://www.accessdata.fda.gov/cdrh_docs/reviews/K110571.pdf

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Department Of Biomedical Engineering M.Sc. Program, Decision Theories for Biomedical Engineering