Excecutive Summary:

A glucometer is a handheld device that is used to measure blood glucose levels. Nowadays the approximate range of blood samples that are needed for the measurement, ranges from around 0.5 µl to 3.0 µl.

Different companies have developed different kinds of glucometers. So, there is a minor variation in the size and features. The general parts of the device include the display unit, power supply unit (battery), test strips port, memory unit, measurement unit, and control buttons.

You will be able to set the date and time in the meter. Besides that, you will also be able to set the blood sample volume for measurement.

Glucose Test Strip

Generally, glucose test strip is coated with an enzyme such as glucose oxidase. The oxidase is capable of catalyzing the oxidation reaction of blood glucose to gluconic acid and hydrogen peroxide. Hydrogen peroxide is an indicator that changes its color during the process of oxidation. In other words, the intensity of the color formation is directly proportional to the intensity of the blood glucose level.

The test strip should not be exposed to an outer environment for a long period of time. Else, the moisture and the sunlight will ruin its chemical composition. Thus, the accuracy of the measurement of glucose will decrease.

The test strips are designed for single use. Also, before you use the test strip, you need to see its life span. Generally, the life span of the strips is about six months. But, I personally suggest you not use it for more than four months.

Each company provides you with its own test strips. So, using the test strip of any other company can give you an incorrect result.

Lancing Device

The lancing device consists of the disposable lancet in it. The lancet is used for drawing out the blood. The video shown below gives you a general idea of how you can load the lancet inside the lancing device

REGUOLATORY STATUS:The Glucometer is in Class C of the risk-based classification of medical devices because it has a medium level of risk. 3. Appointment of Indian Authorized Agent- If the manufacturer is not an Indian, an IAA, or Indian Authorized Agent, has been chosen.

Pricing:Most of the glucometers present in India are in the range of 400 to 1000 rupees.

The growing importance of the "Glucose Meters market" in the present market environment is highlighted in this market research analysis. By examining the Glucose Meters market 2022 to 2028, the report also sheds some light on the market's future. The Glucose Meters market has been divided into a few significant segments and subsegments by analysts to give readers a thorough overview of the market. The segments and subsegments are as follows: Handhold,Wearable,Others. There are numerous uses that the Glucose Meters market may offer to various industries. The programs are Household,Hospitals,Clinics.

The global Glucose Meters market size is projected to reach multi million by 2028, in comparision to 2021, at unexpected CAGR during 2022-2028 (Ask for Sample Report).

The following regions are highlighted in the research study in order to provide a regional analysis of the Glucose Meters market: North America: United States, Canada, Europe: GermanyFrance, U.K., Italy, Russia,Asia-Pacific: China, Japan, South, India, Australia, China, Indonesia, Thailand, Malaysia, Latin America:Mexico, Brazil, Argentina, Colombia, Middle East & Africa:Turkey, Saudi, Arabia, UAE, Korea. The research highlights the overall performance of the Glucose Meters market and lists the top players in the market. The main players of the Glucose Meters market are Roche,Lifescan,Abbott,i-SENS,Omron,ARKRAY,Terumo Corporation,Hainice Medical Inc.,Mendor Oy,Care Diagnostica,ISOtech Co., Ltd,Health & Life,OK Biotech Co.,Ltd,Yuwell,Edan,SANNUO,YICHENG,EGENS,B. Braun,77 Elektronika,Nipro Dagnostics,Infopia Co.,LTD,AgaMatrix Inc,ALL Medicus

 

The Glucose Meters market is divided into the following groups based on its numerous components:

• Roche
• Lifescan
• Abbott
• i-SENS
• Omron
• ARKRAY
• Terumo Corporation
• Hainice Medical Inc.
• Mendor Oy
• Care Diagnostica
• ISOtech Co., Ltd
• Health & Life
• OK Biotech Co.,Ltd
• Yuwell
• Edan
• SANNUO
• YICHENG
• EGENS
• B. Braun
• 77 Elektronika
• Nipro Dagnostics
• Infopia Co.,LTD
• AgaMatrix Inc
• ALL Medicus

The Glucose Meters market is divided into various types, including:

• Handhold
• Wearable
• Others

The following categories make up the market industry research by application Glucose Meters:

• Household
• Hospitals
• Clinics

By area, the list of Glucose Meters market participants is as follows:

• North America:
  • United States
  • Canada
• Europe:
  • Germany
  • France
  • U.K.
  • Italy
  • Russia
• Asia-Pacific:
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • China Taiwan
  • Indonesia
  • Thailand
  • Malaysia
• Latin America:
  • Mexico
  • Brazil
  • Argentina Korea
  • Colombia
• Middle East & Africa:
  • Turkey
  • Saudi
  • Arabia
  • UAE
  • Korea

The following are the main advantages that the Glucose Meters market offers participants and members of the industry:

• The research report includes important financial data on the Glucose Meters market.
• A thorough analysis of the Glucose Meters market based on a number of segments and subsegments is included in the research report.
• The research report focuses on the key geographical trends of the Glucose Meters market and how it is in various regions.

Total Decription:

The Government of India’s Ministry of Health and Family Welfare stated in a notification that the following medical devices would be considered drugs as of January 1, 2021. The devices are as follows:

1. Glucometer

2. Nebuliser

3. Blood Pressure monitoring device

4. Electronic thermometer

All of these devices must be registered in compliance with the quality parameters outlined in the Medical Devices Rules of 2017 and other standards set by the Bureau of Indian Standards (BIS). The proposal to bring nebulisers, blood pressure monitors, digital thermometers, and glucometers under the preview of the Drug law was approved by the Drug Technical Advisory Body (DTAB), which is India’s highest drug advisory body. According to the notification, it is important to obtain CDSCO Medical Device Registration for Glucometer.

The Glucometer is a Class-C medical device; therefore, it is mandatory to register the device with CDSCO. Even the slightest mistake during the registration process could cause the application to be turned down. So, it’s always best to get help from a professional for CDSCO Medical Device registration for Glucometer.

Sensitivity of Glucometer:

The sensitivity of amperometric glucose sensors is usually affected by the concentration of amino  acids  and urea [16,17]. This is because the molecules of these materials have very small size, which enables them to diffuse by the polymeric membrane of glucose sensors. The efforts of different researchers are directed mainly toward eliminating these interfering influences. Two principles have been conceived and both have been utilized for this purpose: separation and differentiation by selectively permeable membranes (molecular size); and potential-dependent reactivity of different plasma components at the electrode [18]. Of course, many researchers succeeded in suppressing adverse effect of amino acids to a tolerable limit of error by covering the electrode with a compact membrane. The simultaneous elimination of the interference of amino acids and urea has also been possible, although with reduced accuracy. Lerner et al. [19] claimed the ability to measure glucose in the presence of amino acids  and urea  with an  error of less than 10%. From the clinical norm point of view this error is significant [20]. This is because, according to the Tonkse criterion [20], the maximum allowable error for glucose measurements is 7.2%. The Tonkse criterion states that the maximum tolerable error for analytical measurements is 0.5S_b, where S_b is the biological standard deviation, which can be easily determined from the range for the  glucose  clinical norm.  The  range  for  the  clinical  norm  for  glucose  inhuman blood is 90 – 120  mg dl71  (105+2S_b). Thus, the biological standard deviation S_b is equal to 7.5 mg dl71.Therefore, the maximum percentage tolerable error is 7.2%. 

determine the effect of urea concentration in blood upon the sensitivity of the glucose sensor, a lot of experiments were carried out. The experiments were performed in vitro using the measuring stand shown in figure 1. The Yellow Springs Instrument (YSI) labora- tory glucose analyser is a standard instrument for glucose measurements. It is used here to calibrate the glucose sensor and to control the glucose concentration in the blood samples investigated.

 

The urea sensor is an electrochemical sensor similar to the amperometric glucose sensor. The only difference between them is that a polysulphone polymer mem- brane with a degree of sulphonation equal to 0.175 is used in the urea sensor instead of a polymer membrane in the glucose sensor, while the remaining parts of both sensors are identical.

Using the polysulphone membrane, urea can be measured free from interference with good accuracy in the presence of glucose and indeed also in the presence of other larger molecules.. Both urea and glucose sensors are in touch with the blood sample in the measuring cell, which is mixed with heparin to improve the biocompatibility of the sensors with the blood sample. The measuring cell is closed to avoid the entrance of atmospheric gases to the blood sample, which may affect also the sensitivity of  the glucose sensor. The range of the output signals (currents) of the glucose and urea sensors is 0 to 20 mA.The current of each sensor is converted into voltage using an op-amp based current-to-voltage (I/V) con- verter [21]. Then, the output signal (voltage) of the I/V converter is amplified using a non-inverting amplifier with a voltage gain (A_v) equal to 100. After this, the output voltage of the amplifier is digitized using the ICL 7107 A/D converter [22].  This  A/D  converter  includes a display driver, thus allowing a direct interface with a three and a half digit liquid crystal display.To investigate the effect of urea upon the sensitivity of the amperometric glucose sensor, the concentration of urea in the  blood sample  (with  fixed glucose concen-tration)  is  changed  from  0  to  600 mg  dl71   and  the output signal (current) of the glucose sensor for each change in urea concentration recorded. This range ofurea concentration change covers the normal (10 – 55 mg dl71)   and   pathological   ranges   (more   than 55 mg dl71) for  a human.  The  in vitro change  of urea in the blood sample is done by adding different known concentrations  of  urea   to  this  sample.  The   measure-ment of sensor current during the change of urea concentration is done at constant glucose concentra- tion in the blood sample. The results obtained for the glucose sensor’s output current (i_sen) and urea con- centration (c_urea) coincide in figure 2.Of course, the glucose sensor’s output current is first measured for the blood sample with a constant glucose concentration with no urea. Then, the urea is added to 

the blood sample and the current is measured for each change in urea concentration. From figure 2, it can be concluded that the current of the glucose sensor is increased if the urea concentration in the blood increases. Thus, the sensitivity of the glucose sensor will be changed and the amount of this change depends on the urea concentration in the blood sample investigated.

 

From the experimental results obtained, the correction factor that represents the influence of urea concentra- tion on the sensor’s output current can be determined. This  factor  is  found  to  be  0.05 mA mg71  dl71   for  the

urea concentration in the range 10 to 100 mg dl71  and

0.01 mA mg71  dl71  for urea concentration in the range 100 to 600 mg  dl71.

The electronic implementation of these two correction factors requires first a measurement of urea concentra- tion in the blood sample investigated. This means that the measurement of glucose in blood requires two sensors: a glucose sensor and a urea sensor. This is because to correct the output signal of the applied glucose sensor from the influence of urea, the urea concentration must be measured (using a urea sensor). Then, the influence of urea concentration upon the current of the glucose sensor can be eliminated  using the following relationships:

i_corr ˆ c_urea £ correction  factor;                       …1†

itrue  ˆ iglucose sensor  ¡ icorr;                            …2† where i_corr is the correction current that represents the influence of urea upon the current of  the  glucose sensor, c_urea is the actual urea concentration in  the  blood sample investigated, i_{glucose sensor} is  the  actual  value of the output current of the glucose  sensor  and i_true is the true value of the glucose-sensor  output current  which is  free of urea  concentration   influences.

 

The value of the correction factor must be selected depending on the range of measured urea concentra- tion. The electronic  realization  of  the previous equa-

 

glucose sensor, a urea sensor, a differential bioelectric amplifier, an A/D converter and a microprocessor system. It is designed to measure the glucose concen- tration   in   the   range   0   to   700 mg dl71     and   urea concentration   in   the   range   0 – 600 mg dl71.   These ranges cover the normal and pathological ranges of blood glucose and urea concentrations [20].

 

The amperometric glucose and urea sensors have linear static characteristic and the sensitivity of the glucose

sensor  is  0.0292 mA mg71  dl71   while  the  sensitivity  of the urea sensor is 0.0237  mA mg71  dl71.

The analogue part of the  designed instrument includes: a current-to-voltage (I/V) converter, an instrumenta- tion amplifier, an active filter and an  A/D  converter. The analogue switch is used to select one  sensor (glucose or urea sensor) at a time. This switch is controlled by the microprocessor. Then, the output signal (current) of each sensor is converted into voltage using an op-amp based I/V converter. Next, the output signal of the I/V converter is  entered  into  the bioelectric amplifier. The designed instrumentation amplifier must have high voltage gain (A_v), high input resistance (R_in) and high common mode rejection ratio (CMRR) [24]. These parameters were  fulfilled  using  the instrumentation amplifier shown in figure 4. The parameters of this amplifier are: A_v = 100,

Essential Principle Checklist:

The main principle of the glucometer is to determine the amount of "sugar" in the blood. There are two variations of this action. The first option is photometric determination, and the second one is electromechanical.

Modern glucometers allow us to show the exact content of human sugar. Thus, the photometric principle of operation is based on the determination of glucose by changing the shade of the reagent. The electrochemical form shows the sugar level by measuring the current that appears during the process.

Devices of modern types for measuring glycemia consist of a system with adjustable ejection of blades in order to pierce the skin, an electronic unit that is equipped with a liquid crystal display and test strips.

Initially, nothing is particularly clear, the device seems strange and it's not at all clear how to use it. In fact, there is nothing wrong with that. Modern instruments allow you to quickly use them. After all, this device should be in the house of every person suffering from diabetes.

Many people are interested in how the glucometer works, and how to measure the glucose level. So, as mentioned above, there are two principles of action. One of them is called photometric, the second - electromechanical.

So, the first option works as follows. In the interaction of blood glucose and a special reagent that will be applied to the test strip, the latter stains blue. So the intensity of the shade depends on the concentration of glucose. The optical system of the device carries out color analysis and, from these data, determines the level of sugar. The truth is, this device has its disadvantages. Too fragile, and it requires special care, and the results obtained have a great error.

The next device is electromechanical. In this case, glucose interacts with the test strip, resulting in a small electrical current. The device, in turn, fixes this value and determines the level of sugar. In this case, the results can be considered more accurate.

MANUFACTURING AND DESIGN:

One way that diabetics monitor blood glucose concentration is by testing blood samples several times throughout the day and injecting the appropriate dose of insulin. Upon doctors' recommendations and using such products, patients typically measure blood glucose level several (three to five) times a day. Generally these blood samples are taken from the finger, but can be taken from other places. A finger-stick comprised of a lancet is used to prick the finger and withdraw a small amount of blood that is placed on a test strip. The test strip is placed in a monitoring kit typically based on the electroenzymatic oxidation of glucose. While there is no known cure for diabetes, studies show that patients who regularly monitor their blood glucose levels and work closely with their healthcare providers have fewer complications in relation to the disease.

 

Using a typical glucometer and lancing device, the sampling and measurement process is generally as follows. First, the user prepares the meter for use by removing a test strip from a protective wrapper or vial and inserting it in to the meter. The glucometer may confirm the proper placement of the test strip and indicate that it is prepared for a sample. Some glucometers also may require a calibration or reference step at this time. The user prepares the lancing device by removing a cover from the lancing device, placing a disposable lancet in the lancing device, replacing the cover, and setting a spring-like mechanism in the lancing device that provides the force to drive the lancet into the skin. These steps may happen simultaneously (e.g., typical lancing devices set their spring mechanisms when one installs the lancet). The user then places the lancing device on the finger. After positioning the lancing device on the finger, the user presses a button or switch on the device to release the lancet. The spring drives the lancet forward, creating a small wound.

After lancing, a small droplet of blood appears at the lancing site. If adequate, the user places the sample on a test strip according to manufacturer's instructions. The meter then measures the blood glucose concentration (typically by chemical reaction of glucose with reagents on the test strip).

Raw Materials

There are many raw materials used to produce a glucose monitoring kit. The test strips consist of a porous fabric or material such as polyamide, polyolefin, polysulfone, or cellulose. There is also a water-based hydroxyl eslastomer with silica and ground titanium dioxide. Water, tramethylbenzidine, horseradish peroxidase, glucose oxidase, carboxymethylcellulose, and dialyzed carboxylated vinyl acetate ethyl copolymer latex are also used.

The meter itself is composed of a plastic case that houses the printed circuit board and sensors. There is a liquid crystal display (LCD) that will show the readings of the blood glucose.

The lancet is composed of a stainless steel needle encased in a plastic housing.

Design

There are many different forms of glucose test kits. Some glucometers have needles al-ready installed. The user only presses the release button and the meter ejects the needle prick and withdraws a sample. Others require a separate lancet and test strips. These are the most commonly used forms of glucose kits.

The meter itself typically has a LCD display at the top of the machine. In the middle towards the bottom is a horseshoe-shaped slot in which to fit the test strip. Underneath this slot is a sensor that transmits the readout from the blood sample. The device runs off of batteries and usually has a short term memory built in to remember past glucose readings. Some devices can be hooked up to computer programs to track these readings and printout charts and diagrams depicting drastic shifts.

The Manufacturing
Process

Test strips

1. The test strip is preferably a porous membrane in the form of a non-woven, a woven fabric, a stretched sheet, or prepared from a material such as polyester, polyamide, polyolefin, polysulfone, or cellulose.
2. A test strip is manufactured by mixing 40 g of an anionically stabilized (3.8 parts by weight sodium lauryl sulfate and 0.8 parts by weight dodecyl benzene sulfonic acid) water-based hydroxyl elastomer, containing about 5% by weight colloidal silica and 5 g of finely ground titanium dioxide. Then I g of tetramethylbenzidine, 5,000 units horseradish peroxidase, 5,000 units glucose oxidase, 0.12 g tris, and 10 g of water (hydroxymethyl) aminomethane (buffer) are mixed into the batch.
3. After mixing to ensure a homogeneous blend, the batch is cast onto a polyethylene terephthalate sheet for added structural integrity in a carrier matrix, and dried at 122°F (50°C) for 20 minutes.
4. Next, 100 mg of 3-dimethyl amino benzoic acid, 13 mg of 3-methyl-2-benzothiazolinone hydrazone, 100 mg of citric acid monohydrate-sodium citrate dihydrate, and 50 mg of Loval are added in dry form to a 50 ml tube.
5. These dry materials are mixed with a spatula, then 1.5 g of 10% water solution of carboxymethylcellulose is added and mixed thoroughly with the above solids.
6. Next, 2.1 g of dialyzed carboxylated vinyl acetate ethyl copolymer latex is added and thoroughly mixed.

   The latex copolymer had been dialyzed (separation of larger particles from smaller particles) by placing about 100 g of carboxylated vinyl acetate/ethylene copolymer emulsion into a membrane tubing. The filled membrane was soaked in a water (distilled) bath at 68°F (20°C) for 60 hours to allow low molecular weight particles, unreacted monomer, catalyst, surfactant, etc. to pass through the membrane. During the 60 hours the water was continuously changed using an overflow system. The remaining dialyzed emulsion was then used in preparing the reagent layer.

7. Then 0.18 ml of glucose oxidase is pippeted to the tube as a liquid. Next, peroxidase is pipeted as a liquid to the tube and tartrazine is pipeted to the tube. The resulting mixture is mixed thoroughly. This mixture is allowed to stand for approximately 15 minutes.
8. A polished-matte vinyl support prior to being coated with the above solution was cut to form cell rows and then wiped clean with methanol. The mixture is pulled into a 10 ml syringe and approximately 10, 6 mm drops are placed on each cell row. The coated cell row is heated in an oven at 98.6°F (37°C) for 30 minutes followed by 113°F (45°C) for two hours. This process of coating and spreading the mixture is repeated for each cell row. The cell rows were then cut into strips of the desired size.
9. These strips were packaged with absorbent packs of silica gel and dried overnight at approximately 86°F (30°C) and 25 mm/Hg vacuum.

The glucometer

1. A molding press is loaded within the mold cavities, and a pellet of encapsulating material (thermoplastic resins used in the injection molding such as phenol resin, epoxy resin, silicone resin, unsaturated polyester resin, and other thermosetting resins) is placed in a receiving chamber.
   1. Encapsulation of the integrated circuits (of the glucose detector) is achieved by heating the encapsulating material pellet and pressing it within the chamber using a transfer plunger, which causes the pellet to liquefy and flow into the mold cavities through small passages between the chamber and the mold cavities.
   2. After allowing the encapsulating material to solidify again, the molding press is opened and the mold parts are separated.
   3. After removal of the encapsulated integrated circuits, the open molding press is ready to receive new inserts and encapsulating material pellet to repeat the encapsulating process.

      The lancet

      1. Blood lancets today are generally manufactured using either an injection-molding process or an assembly process. In the injection-molding process, the wire is held in place by the adherence of the wire to the surrounding finger grip material.
      2. The finger grips are generally made of plastic material such as polyethylene. The sharp point of the wire is embedded in a point cover with a narrow neck attaching the point cover to the finger grips.
      3. The point cover maintains the wire point clean until use. When the lancet is to be used, the point cover is twisted off at the neck, exposing the wire point for use.
      4. The assembly process involves attaching the wire to the finger grips with an adhesive such as thermal epoxy, two-part epoxy, or ultra violet adhesive.
      5. A cap is then placed over the wire point for protection and sterility. When the lancet is to be used, the cap is twisted off at the neck, thus exposing the wire point for use.

VERIFICATION AND VALIDATION:

Fifty of the 150 glucose meters (AccuCheck Inform II, Roche Diagnostics, Mannheim, Germany) located over all the buildings of the hospital were included in the present study. Two pools of human serum were obtained from residual specimens from inpatients. All had negative serological screen- ing results for viral infections (human immunodeficiency virus and hepatitis). The 2 different pools contained 20 mL of each level with glucose values of L1 = 70.3 ± 0.02 mg/dL and L2 = 296 ± 0.05 mg/dL (mean values and SD by 8 runs) using a Cen- tral Laboratory method (glucose oxidase, GLUO V1.02.00 on the ADVIA 2400, Siemens Diagnostics, NY). The pools were stored at −20°C before being sent to the hospital units. All samples were delivered to care units directly by the laboratory operators. Overall working time for sample preparation and deliv- ery was registered by the laboratory operators, whereas the time for running the samples was registered by the nurses. Both samples were analyzed on 2 different days (at least 1 month apart

FIGURE 1. Overall distribution of results for the 2 glucose levels. Low level: mean value: 80.23 ± 1.85 mg/dL. High level: mean value: 308.3 ± 8.3 mg/dL.

between the 2 evaluations). The results were used to obtain data on the instruments' analytical performance and to determine the bias between the POC devices and the laboratory instruments. A specific report was used to send the results of each device to the units at the end of the analytical assessment with the instructions to review the results in the unit and file with the documents for the devices.

 

RESULTS

Mean values of all instrument results were in L1 = 80.23 ±

1.85 and in L2 = 308.3 ± 8.3. The distribution of values for the 2 samples on both runs is shown in detail in Figure 1. The mean bias between the laboratory method and the POC devices (without reference method) was L1 = 6.59% and L2 = 2.03%. No total error more than 15% was observed in the 200 values of collected data; 1 data point showed a total error greater than 10% (L1); and 7 samples showed a total error of more than 5% (both levels; Fig. 2). An example of a final report for a care unit with the specific instructions by the POCT manager is shown in Figure 3.

A total of 36 hours and 40 minutes of labor was required for the quality assessment program. The mean working time reported

between the 2 evaluations). The results were used to obtain data on the instruments' analytical performance and to determine the bias between the POC devices and the laboratory instruments. A specific report was used to send the results of each device to the units at the end of the analytical assessment with the instructions to review the results in the unit and file with the documents for the devices.

 

RESULTS

Mean values of all instrument results were in L1 = 80.23 ±

1.85 and in L2 = 308.3 ± 8.3. The distribution of values for the 2 samples on both runs is shown in detail in Figure 1. The mean bias between the laboratory method and the POC devices (without reference method) was L1 = 6.59% and L2 = 2.03%. No total error more than 15% was observed in the 200 values of collected data; 1 data point showed a total error greater than 10% (L1); and 7 samples showed a total error of more than 5% (both levels; Fig. 2). An example of a final report for a care unit with the specific instructions by the POCT manager is shown in Figure 3.A total of 36 hours and 40 minutes of labor was required for the quality assessment program. The mean working time reported

by the nurses in care units for running the samples was of 7 ± 5 minutes for each of the 2 deliveries, resulting in a total time of 11:40 hours. Working time for laboratory operators was 15 minutes for each device and sample delivery. The total of 25 hours of time for the laboratory operators was divided into 7 hours for sample preparation, 12 hours for sample delivery, and 6 hours for data analysis. The overall breakdown of the time required for the program is shown in Figure 4.

 

The growing importance of the "Glucose Meters market" in the present market environment is highlighted in this market research analysis. By examining the Glucose Meters market 2022 to 2028, the report also sheds some light on the market's future. The Glucose Meters market has been divided into a few significant segments and subsegments by analysts to give readers a thorough overview of the market. The segments and subsegments are as follows: Handhold,Wearable,Others. There are numerous uses that the Glucose Meters market may offer to various industries. The programs are Household,Hospitals,Clinics.

The global Glucose Meters market size is projected to reach multi million by 2028, in comparision to 2021, at unexpected CAGR during 2022-2028 (Ask for Sample Report).

The following regions are highlighted in the research study in order to provide a regional analysis of the Glucose Meters market: North America: United States, Canada, Europe: GermanyFrance, U.K., Italy, Russia,Asia-Pacific: China, Japan, South, India, Australia, China, Indonesia, Thailand, Malaysia, Latin America:Mexico, Brazil, Argentina, Colombia, Middle East & Africa:Turkey, Saudi, Arabia, UAE, Korea. The research highlights the overall performance of the Glucose Meters market and lists the top players in the market. The main players of the Glucose Meters market are Roche,Lifescan,Abbott,i-SENS,Omron,ARKRAY,Terumo Corporation,Hainice Medical Inc.,Mendor Oy,Care Diagnostica,ISOtech Co., Ltd,Health & Life,OK Biotech Co.,Ltd,Yuwell,Edan,SANNUO,YICHENG,EGENS,B. Braun,77 Elektronika,Nipro Dagnostics,Infopia Co.,LTD,AgaMatrix Inc,ALL Medicus

 

The Glucose Meters market is divided into the following groups based on its numerous components:

• Roche
• Lifescan
• Abbott
• i-SENS
• Omron
• ARKRAY
• Terumo Corporation
• Hainice Medical Inc.
• Mendor Oy
• Care Diagnostica
• ISOtech Co., Ltd
• Health & Life
• OK Biotech Co.,Ltd
• Yuwell
• Edan
• SANNUO
• YICHENG
• EGENS
• B. Braun
• 77 Elektronika
• Nipro Dagnostics
• Infopia Co.,LTD
• AgaMatrix Inc
• ALL Medicus

The Glucose Meters market is divided into various types, including:

• Handhold
• Wearable
• Others

The following categories make up the market industry research by application Glucose Meters:

• Household
• Hospitals
• Clinics

By area, the list of Glucose Meters market participants is as follows:

• North America:
  • United States
  • Canada
• Europe:
  • Germany
  • France
  • U.K.
  • Italy
  • Russia
• Asia-Pacific:
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • China Taiwan
  • Indonesia
  • Thailand
  • Malaysia
• Latin America:
  • Mexico
  • Brazil
  • Argentina Korea
  • Colombia
• Middle East & Africa:
  • Turkey
  • Saudi
  • Arabia
  • UAE
  • Korea

The following are the main advantages that the Glucose Meters market offers participants and members of the industry:

• The research report includes important financial data on the Glucose Meters market.
• A thorough analysis of the Glucose Meters market based on a number of segments and subsegments is included in the research report.
• The research report focuses on the key geographical trends of the Glucose Meters market and how it is in various regions

 

POST MARKET SURVELLENCE:

BGMSs are an essential tool for monitoring control of diabe- tes. Marketing of BGMSs is controlled in the United States by the US Food and Drug Administration (FDA). Clearance by the FDA requires conformance to performance guide- lines, which have been gradually requiring greater analytical accuracy (see Table 1). Accuracy of results is critically important first, for the safety of subjects to know whether they require immediate treatment to modify their glucose levels and second, so that medications can be titrated to reach a point of maximal effectiveness as defined by each trial. This tool is particularly important during many clinical trials where the outcome of treatment is defined with a blood glu- cose value.

Accuracy is doubly important in a clinical trial where the endpoint is hypoglycemia, because a falsely low reading may lead to an incorrect conclusion that a treatment may not be safe—when it actually is safe. Also, a falsely elevated glucose level can lead to excessive titration of medication and can

 

lead to an increased number of hypoglycemic episodes. A positively biased BGMS will usually manifest itself by two outcomes: (1) an unusually large number of hypoglycemic readings and (2) a lower than expected HbA1c level, because blood glucose levels will be driven downward by excessive and unnecessary medication titration. These two outcomes both occurred in the clinical trial that was discussed in the Philis-Tsimikas article.¹

The risks of a clinical trial are spelled out in an informed consent form (ICF) for a subject to sign. For a trial of a diabe- tes drug or device requiring blood glucose monitoring for safety, I have never seen an ICF that presents a risk of the study as an inaccurate blood glucose reading that can result in excessive insulin dosing and an increased risk of hypoglyce- mia. If this were a known problem with BGMSs used in clini- cal trials, then such a risk might well be considered unsafe by many institutional review boards (IRBs) and patients, and far fewer trials of diabetes products would be authorized by IRBs.

 

Accuracy Results in a Two-Part Surveillance Study

In this issue Pfützner and colleagues as well as Demircik and col- leagues each report one part of the results of a two-part surveillance study that they were contracted by Novo Nordisk to conduct in order to evaluate the analytical accuracy of the BGMS used in the Philis-Tsimikas study. These two accuracy studies were performed generally in accordance with the ISO15197:2015 (the European harmonized version of ISO15107:2013) guidelines with additional 

data collection in the hypoglycemic range (below 100 mg/dl) where the BGMS was suspected to be most inaccurate. First, Pfützner and colleagues concluded that the tested BGMs did not meet the mini- mum accuracy criteria specified for this study.³ Second, Demircik and colleagues concluded that the BGMs met repeatability require- ments, but their studies also demonstrated a significant positive measurement bias in the low range (below mg/dL).⁴ In addition, in their studies the product failed the ISO15197:2015 criteria for hematocrit interference. These two analytical accuracy studies were a form of postmarket surveillance testing. This type of testing is not the same as registration testing or determining whether a product is FDA or ISO compliant. In a surveillance study to meet predetermined performance criteria, the number of tests performed might be fewer than what is mandated for registration, not every test procedure is necessarily performed, and in some cases, the product testing method or reference method is not performed exactly as mandated by the manufacturer, in order for the surveil- lance testers to save time or money or for the testing to be more convenient for test subjects.⁵ An ideal surveillance study for accu- racy will be performed as closely as possible to registration meth- ods and reasons for any deviation from the required method as laid out in the standard or guidance will be explained.

Both Pfützner and Demircik were not able to obtain their test materials from an environmentally controlled supply chain where the strips could be certified as having been stored at room temperature and humidity before being sent to these investigators. In the two studies, however, all strip lots and devices received at their common test site in Germany from various geographical locations displayed the same measurement bias, which suggested that the inaccu- racy was due to a systematic problem, rather than improper storage.

Linearity studies performed by Demircik and colleagues on glycolyzed specimens did not measure pO2, which must be maintained at a steady concentration when evaluating glu- cose oxidase-based BGMSs like the one tested in these three articles. The literature contains data suggesting both that measurement and formal stabilization of ambient pO2 is⁶ and is not⁷ necessary for accurate testing of BGMSs containing this enzyme.

 

Although the results by Pfützner, Demircik, and their col- leagues cannot be used to definitely conclude that the MyGlucoHealth would not meet registration criteria for accuracy if the product were to be tested now according to all the criteria mandated by FDA or ISO, their two studies are nevertheless important. The results demonstrated by these investigators in the low range (below 100 mg/dl) were very striking. They reported that 203 of 300 specimens tested with the BGMS were outside the ±15% acceptance limit in this range, whereas per ISO 15197 2013 no more than 15 of their specimens should have been outside this range and per FDA 2018 draft, no more than 15 specimens out of every 300 specimens of any blood glucose level should have been out- side of this ±15% range (see Table 1). The data collected by Pfützner, Demircik, and their colleagues are highly suspi- cious for inaccuracy and suggests a hypothesis that the MyGlucoHealth would not pass 15197:2013 or FDA 2018 draft criteria if it were to be tested now for accuracy accord- ing to package insert instructions by way of a comparison method exactly specified by either regulatory agency.

 

LABELLING:

Intended Use:

Blood glucose meters are reviewed as part of a system that includes the meter, test strips, lancing devices, and control solutions. These systems are currently cleared for professional use only, home use only, or for both professional and home use as indicated in the Indications for Use Statement. However, BGMS are generally packaged with multiple use lancing devices (e.g., lancets with re-useable holders, etc.) regardless of whether they are intended for single patient or multiple patient use. An important step in preventing bloodborne pathogen outbreaks is to distinguish single patient use devices from multiple patient use devices. Therefore, all BGMS sponsors should provide the following:

1. Sponsors should decide whether their device is intended for single patient use, for multiple patient use, or both. If only for one use (single patient use or multiple patient use) the sponsor should follow the recommendations below for the use they choose. The “single patient-home use” IFU statement should clearly state that the BGMS is intended for use by lay users and should only be used by a single patient. The “multiple patient, professional use” IFU statement should clearly state that the BGMS may be used for multiple patients in a professional healthcare setting (ie. hospitals, doctor’s offices, etc.). At the current time, we will continue to allow sponsors to check “OTC” on the Indications for use form even for the “multiple patient, professional use” device.
2. Sponsors who wish to sell their device for both uses should create distinct products. These products may have the same technical components (e.g., same meter and test strips and same performance data), but they will be considered separate devices. The two device systems (meter and test strips) will have separate names (e.g., “ABC blood glucose test system” and “ABCmulti blood glucose test system”), separate Indications for Use (IFU) statements (submitted on separate forms), and separate product labeling. Please note that though these will be considered separate device systems, we will currently allow both uses to be bundled in a single 510(k) submission and we will accept one set of performance data for both products (provided the only difference is the name and labeling). The devices will be categorized for CLIA separately under the two distinct names.
3. Distinct BGMS starter kits should be provided for each intended use. The single patient BGMS kit may contain either an auto-disabling, single use lancing device or a multiple use lancing device. However, the multiple patient BGMS kit can only contain auto-disabling, single use lancing devices. The labeling for BGMS intended for multiple patient use should clearly state that only auto-disabling, single use lancing devices should be used with this system and instructions on how these auto-disabling lancing devices can be obtained should be provided.

2. Validated cleaning and disinfection procedures:

Please provide validated cleaning and disinfecting procedures for your BGMS (regardless of its intended use) for our review. Your cleaning and disinfecting validation study should include the following:

1. Selection of cleaning and disinfection solvents and procedures that do not result in physical deterioration of the device overall, or deterioration of any device component such as the housing or touch pad or buttons. Please make note of these physical indicators during your study and provide this information for our review. The disinfection solvent you choose should be effective against HIV, Hepatitis C, and Hepatitis B virus. Outbreak episodes have been largely due to transmission of Hepatitis B and C viruses. However, of the two, Hepatitis B virus is the most difficult to kill. Please note that 70% ethanol solutions are not effective against viral bloodborne pathogens and the use of 10% bleach solutions may lead to physical degradation of your device. A list of Environmental Protection Agency (EPA) registered disinfectants effective against Hepatitis B can be found at the following website: https://www.epa.gov/pesticide-registration/list-d-epas-registered-antimicrobial-products-effective-against-human-hiv-1
2. Demonstration that your disinfection protocol is effective against Hepatitis B virus. We recommend demonstration of disinfection effectiveness through viral challenge of the material used to manufacture the housing of the meter. It is not necessary to do viral challenge studies with the actual meter. Please note that your disinfection protocol should contain solvent appropriate contact times. Please see Attachment 1 for more information on disinfection protocols.
3. Demonstration through bench studies that your BGMS is robust to cleaning and disinfection procedures after multiple cleaning and disinfection cycles. Please use worst case scenarios with regards to cleaning and disinfection frequency and end user environment. For example, the number of times you clean/disinfect the meter should be representative of the cleaning/disinfection that the meter will be exposed to in its 3-5 year life. To determine the appropriate number of cleanings/disinfections  for the study we suggest considering the number of times a meter will likely be cleaned/disinfected per day in its end user environment and extrapolating that number to the life of the meter.  Please note that for single patient BGMS kits, you should also demonstrate that lifetime cleaning of any re-useable lancing devices packaged with your meter does not affect its performance. Accelerated testing would be appropriate here to simulate the cleanings/disinfections over the life of the meter and lancing device. These studies should demonstrate that the analytical performance of the blood glucose monitoring system is not impacted by the cleaning and disinfection procedures.
4. Please provide a description of how the cleaning and disinfection procedures affect the port of your meter. If you determine that your meter port can not withstand your cleaning and/or disinfection procedures, you should work to ensure that future designs of your meter can withstand cleaning and disinfection at the port and other openings. The meter port is highly susceptible to blood contamination, therefore it is important to be able to clean and disinfect this portion of your meter to reduce the risk of bloodborne pathogen transmission.
5. When you evaluate your device after the disinfection phase please keep in mind that the disinfectant should not cloud the face/display of the meter and should not corrode or erode the plastic housing or buttons.  Please make note of these physical indicators during your study.
6. Please include infection control in your risk analysis studies and incorporate these validated cleaning and disinfecting procedures into your risk assessment.
7. Please provide a description of the protocols and acceptance criteria for all studies.
8. To assist sponsors, FDA is working on more specific recommendations for cleaning and validation studies and will provide these in the near future.

3. Separate labeling for each BGMS kit:

Please submit separate labeling (user manual, quick guide, test strip labeling, and box labeling) for each BGMS for our review. The user manual should contain instructions for how and when users should perform cleaning and disinfection procedures for the meter and/or lancing devices, based on the studies performed (note that both the single and multiple use devices should contain thorough instructions on cleaning and disinfection). Also, lancing labeling should contain appropriate warnings on lancing device use. For example, for single patient BGMS kits, the lancing device labeling warning should state that the lancing device is only intended for a single user and should not be shared between users. In addition, the labeling should provide specific information on the appropriate use of the device (e.g., single or multiple patients, proper limitations and warnings, etc.). Please see Attachment 2 for initial specific labeling recommendations.

4. System accuracy and user performance studies:

System accuracy and user performance studies for blood glucose monitoring systems include multiple users and multiple blood glucose monitoring devices. Please note that from this point forward, only auto-disabling, single use lancing devices should be used in these studies. The protocol for these studies should include detailed cleaning and disinfection procedures that were followed and what additional measures were in place to mitigate the risk of potentially transmitting disease between healthcare providers, subjects and users (for example use of disposable gloves or other physical barriers). The user performance study protocol should also include details on how often gloves of the trained health professionals were changed between users. Glucose meters should be cleaned and disinfected between subjects in all validation studies performed by the sponsor.

5. Special 510(k)s:

If you are planning to submit a new BGMS Special 510(k), the intended use, validated cleaning and disinfection procedures, and labeling considerations discussed above in Items 1 to 3 apply. However, these Special 510(k) submissions will not generally require conversion to Traditional 510(k)s to address the considerations discussed in this letter.

Please note that these measures are only one step in the path forward to reduce the incidence of bloodborne pathogen transmission by BGMS and to protect public health. The FDA is continually evaluating the regulatory actions necessary to address the safe use of BGMS devices. Additional requirements may be necessary in the future to ensure patient safety. FDA is committed to being as transparent as possible in this endeavor.

 

6. HOW TO USE:The procedure for the usage of glucometer should be specified 

7.WARNING:Information regarding the storage of glucometer and as well as the information regarding the battery present in the glucometer should be specified