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BUILT BY EUGENE KAGANOVICH
Lancing Device Comparison
Accuracy of the glucose meter
Accuracy of the glucometers is one of the controversial questions. According American Diabetes Association (2011) if blood sugar below 100 or above 100 glucometers errors must be no more than 15%. Every meter is calibrated differently, error allowed by FDA is 20%. In my opinion it must be 0, but it’s impossible . FDA has difficult time to collect errors information about glucometers, because clients do not report problems to FDA.
If you report errors with your meter to the customer service they will ask if you experienced any health problem because of malfunction of the meter. If you did experienced hypoglycemia or hyperglycemia, and what next they will report to FDA or just simple replace your meter. How many times did you receive the letter for recall of your meter?
MARKET OF GLUCOSE METERS.
The market for home glucose meters are over $4 billions (Howell, Kissinger, Kaufman, & Jui Yeh). Some resource show information even higher as $25 billions for glucose meter market. Statistical prediction is shocking "by the end of 2013 there was 382 Million people suffering from diabetes and this figure is expect to rise further to 592 Million by 2035" (Blood Glucose Device Market worth 592 Million by 2035, 2014). United States has highest number of test strips market share worldwide.
Roche Diagnostic, LifeScan Inc, Bayer HealthCare and Abbott Laboratories together controls nearly 50% market share of self-
TYPES OF THE TEST STRIPS.
Development of electrochemical test strips started in 1987. The electrochemical strips is made by screen printing a conductive carbon ink on a plastic substrate. Measurements of blood sugar is based on reaction of an electrochemically active mediator with an enzyme (Bronzino & Peterson, 2014). Enzymes convert glucose into electrical current (chemical reactions into electricity). Two types of enzymes are glucose oxidase or glucose dehydrogenase.
Test strips contain a capillary that sucks up blood sample, the glucose in the blood reacts with an enzyme electrode containing glucose oxidase. The mediator in turn is reoxidised by reaction at the electrode,which generates an electrical current.
Test strips containing GDH-
NEW TYPE OF THE TEST STRIPS.
In 2006 -
FDA and ISO guidelines on the accuracy of glucometers have been in place since 1996
95% of the reading must be withing 20% of a reference method for glucose >75 mg/dl and withing 15 mg/dl for glucose value < 75 mg/dl
In 2009 requirement was changed to 95% withing 15% for glucose value > 75 mg/dl and withing 10 mg/dl for glucose number < 75 mg/dl
I followed many discussions how to improve quality of glucometers and test strips.
FDA has proposed changing guidelines on the accuracy of glucometers, make it tighter for home and clinical-
Market of glucose meter is over $4 billions, why not to invest some amount of the profit for development higher quality glucometers? Why meters which cost fraction perform better that more expensive models? Why US market is closed for other meters from Eropian countries? Most health insurances are covering highest price cost for test strips, price of the 100 test strips run between $20 up to $ 150. Anyone can explain this WHY? Yes companies invest money in development, research studies and manufacturing, absolutly it involve expenses. But this expenses comes with huge profit.
Technology in glucose monitoring moving toward continuous glucose monitoring systems which is more complicated and has one of the MOST sofisticated algorithm for displaying blood sugar numbers. If companies moving toward high end technology how difficult it wil be developed new high quailty of the glucometers.
Blood glucose device market worth 592 million by 2035. (2014, Mar 20). PR Newswire Retrieved from http://search.proquest.com/docview/1508825244?accountid=458.
Bronzino, J., & Peterson, D. (2014). Medical Devices and Human Engineering. CRC Press.
Howell, J., Kissinger, P., Kaufman, A., & Jui Yeh, H. (n.d.). Glucose Test Strips and Electroanalytical Chemistry in the. Evansville: Department of Chemistry.
It is not fun to poke your finger every day. Your finger becomes sore. I described two models which I like and one model that is not available anymore. It was one of the best lancet devices on the market, and it was very expensive. I own this model, and you will be surprised it works. Unfortunately, I have no more drums for this electronically lancing device. This model is out of the market now.
Pelikan Sun Lancing Device
Pelikan Sun electronic lancing device is not available anymore on the market. I purchased in 2009. It was made in USA. From my past experience, this is one of the best lancing devices. It was entirely painless. You can see from picture size is huge for lancing device. It comes with cartridges, which include 50 lancets. What was so cool is the depth that can be set to obtain the blood drop. There are 30 lancing depths from 0.1 to 3.0 increments. Insurance didn’t cover Pelikan Sun lancing device. Price for lancing device was $199 and 2 lancet discs (100 lancets) for $14.99. What make me think why insurance didn’t cover what was painless for obtaining the blood samples for children and adult? No answers but they cover device, which is painful and has many drawbacks. At this time, none of the companies have a similar products like Pelikan Sun, and I do miss them.
New 6 pre-
Redesign mechanism of lancing device.
11 depth settings.
Easy to use.
Design is intuitive.
Lancet 30 G
OneTouch Delica Lancing Device
Small Lancing device.
7 depths, I’m not sure who can use #7 depth? It is not easy to operate.
The parts are too small for inserting lancet in the lancing device. Required more than one attempt to penetrate skin.
Lancet 33 G
- Resolution of the screen. Colour or black and white
- Size of the meter
- Meter do not require to enter test strips ‘code
- Ability to upload readings to the software.
- Errors notification
- Cost of test strips.
- How big memory of the meter
- Ability to mark blood sugar reading such as before or after meals
- Alarms. To check blood sugar in 2 hours and etc
- Customer Service.
- Any upgrade options.