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2. ISIC GlucoVision Looking to the Future Automated Glucose Testing Jefferson Lin CEO Victor Chiang CRO COO Sean Cleary CTO Shun Yu CMO Zhen Yu Andy Zheng CFO Faculty Advisor Christopher Jacobs DS1 Design Problem amp Design Brief Design Problem In the United States alone 23 6 million people roughly 7 8 of the population have diabetes Glucose meters have become essential management devices used by these individuals on a daily basis Amongst the 10 million elderly diabetic patients however approximately 50 suffer from arthritis and almost 45 also suffer from diabetic retinopathy For these individuals with both visual and dexterity impairment even seemingly routine procedures like pricking their fingertips and using the glucose meters may prove difficult Furthermore the amount of blood acquired on testing strips sometimes proves insufficient requiring repeated attempts to extract more blood Design Brief We propose an augmentation of current devices by designing an add on to complement existing meters The new design will aim to provide stationary support during the testing procedure and requires minimal dexterity for blood extraction via fingertip punctures It should provide the means to automatically extract and detect that enough blood has been acquired for testing without causing the patients additional discomfort It will be easy to use and sufficiently adapted for sterilization to prevent i
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4. Meter requires only a 0 6 microliter sample volume and results appear in 5 seconds Test results can be stored into a 300 value memory and downloaded to a PC via infrared with proprietary ACCU CHEK software Device features a detachable lancet which can be used attached or detached from the blood glucose meter User is asked to press a plunger on the lancing device like a pen one the test site Audible alarms can be programmed to remind the user up to 3 times a day to check blood glucose levels MSRP 85 00 Comments This product utilizes a rotating drum of test strips as a means to eliminate individual strip handling It s similar to our idea of loading multiple strips onto a rotating disk or a conveyor belt However each individual strip still needs to be discarded with this device and the lances still need to be individually loaded and replaced during each test Our product will be advantageous because after loading a whole disk or conveyor belt no further action needs to be done in terms of replacement until the entire disk belt runs out The device also includes a lot of removable parts including the lancing device very rapidly launches and then retracts the lances and various caps which may not be convenient for the elderly population our add on will target Although the alternate sites palm forearm upper arm and thigh testing capability of the device is worth considering k blood glucose meters More p
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6. Print this Page D E mail this Page Larger Type Home oo ACCU CHEK Comfort Curve Test Strips ACCU CHEK Products Purchase Comfort 00 707 NOPE Lire R The ACCU CHEK Comfort Curve test strips used with ACCU CHEK Curve test strips About Diabetes Advantage and ACCU CHEK Complete add to each systems ease of use with their unique shape small sample size requirement and ability o pull blood into the strip Purchase asier blood application urved strip fits your finger for easier blood application small blood samples Comfort Curve Dosing is easy since the strips require a small sample size asier handling Easy to use est strips are designed to be touchable so you don t need to start over if you touch the strip Veit ig K onfident testing the yellow window is full you have enough blood in the test strip If it s not full more blood can be For Testing pplied within 15 seconds Glucose in Whole Blood Accurate results dd 7 igh quality electrodes with palladium deliver improved accuracy and dependability You can trust the Advantage esults even at extreme temperatures from 57 to 104 F test strips in hospitals Blood Glucose Monitors surance 50 onitoring your blood sugar is one of the most important elements of managing your diabetes Whether Roche ou rely on private insurance or Medicare our Insurance Information page can help you get reimbursed Test Strips
7. The Gluco Vatch monitor a newly developed product of Cygnus Inc is a wrist worn device that provides automatic non invasive measurement of glucose levels for adults with diabetes It has a disposable sensor that adheres to the wearer s wrist allowing measurement of sugar levels in the interstitial fluids on the outermost layers of the skin of the wrist Although itis not yet FDA approved for use by diabetics and is still being tested and considered an investigative device diabetics around the world anxiously await its release How the GhicoWatch Monitor Works Before use the Glucovvatch monitor must first be calibrated The wearer may do this by taking an initial glucose measurement using the traditional finger pri calibrated the monitor can provide up to three glucose readings each hour for 12 hours The GlucoVWatch monitor uses reverse iontophoresis to collect intact skin Similar to the transdermal medication patches used for smoking cessation and hormone therapy iontophoresis is a non invasive needle free m controlling the transport of water soluble ionic electrically charged drugs out of the skin and surrounding tissues using a low level of electrical current A single use sensor containing gel collection discs gathers glucose samples The gel collection discs contain the enzyme glucose oxidase As glucose entg the glucose oxidase in the gel to form hydrogen peroxide A biosensor in contact with each gel collection disc detects
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9. insulin or exercise The measured levels at alternate sites appear to change more slowly than in the fingertips due to their vasculature The fingertips are source of arterial blood whereas alternative site testing usually test venuous blood After one has a meal their glucose levels change rapidly Arterial blood is the fastest indicator of blood since glucose is directly absorbed into the blood stream and pumped toward the extremities This means that alternative site test results may be different from fingertip test results not because of the meter s ability to test accurately but because the actual glucose concentration can be different Recent studies over the past few years have compared the accuracy of alternate site testing results with results from fingertip blood glucose monitoring The studies have generally shown that during routine blood glucose monitoring such as before meals or two or more hours after meals or exercise the results from alternate sites correspond well with results from fingertip monitoring However because glucose utilization in the fingertips is faster than in the arms or other sites when blood glucose level is falling rapidly e g immediately after exercise or rising rapidly e g right after a meal alternate site readings lag behind fingertip readings This could result in delayed detection of hypoglycemia or sharp changes in blood glucose level Therefore alternate site testing should not be performed dire
10. latest televisions and digital cameras The screen is also self illuminating and high contrast for readability and viewable from a wide angle Plus it comes in five brilliant colors http www animascorp com animas onetouch ping insulin pump aspx Summary OneTouch Ping An insulin pump that also detects glucose levels Wireless information shared between the OneTouch meter and the OneTouch pump The pump is capable of calculating and delivering necessary bolus It s also capable of giving very small dosages down to 0 025U hr for basal dosing Detects and stores information about carb content in consumed food and then delivers necessary amount of insulin It s also waterproof up to 12 meters for 24 hours and therefore works while the patient s in the pool or caught in the rain MSRP To be determined Comment This device was something that we came across and thought was very neat Not only is it capable of detecting blood sugar levels it can relay the information wirelessly to an insulin pump and have that pump deliver the appropriate amount of insulin This requires a needle to be subcutaneously imbedded in the patient for extended periods of time which is something we thought we d steer away from The water proof aspect however was a protective aspect of the device maybe our add on can incorporate as well assuming it s not too complicated to implement 10 ACCU CHEK mu E Help Me Navigate Meter Warranty A
11. on the attached lancing lt messages and meter and advance a device You can Black Cap Clear Cap results stored in test strip Also at the Lancet Use this cap for Use this cap for memory completion of a test i fingertip testing only non fingertip testing only M Button slide and release this unattached Prese this bition button to tum off the A Protective 1 Comfort Dial with Depth Selection to review results in meter and release Battery Cover This shows the number of the memory the test strip Slide the cover Drum Door to unlock and setting on the comfort dial Covers the 1 S Button kek SNA open the battery compartment where d Press this button to compartment the test drum goes EE the T year Test Strip Slot uran x res Strip Count Test strips come out Window Shows of the meter here Drum Door Tab the number of test Lancing Device Lift up on this tab to strips remaining in i open the drum door a test drum Plunger http www accu chek com us rewrite content en US 2 1 10 article ACCM general article 2353 htm Summary ACCU CHEK diabetic meter systems Portable blood glucose meter that utilizes a pre loaded drum of 17 diabetes test strips to eliminate individual strip handling Disposable test drums are sold separately Device can be used to test from patient s fingertip palm forearm upper arm thigh or calf ACCU CHEK Compact Plust Bood Glucose
12. our customers to suffer from similar dexterity and visual impairments The intuitive design that eliminates the need for elderly users to interact with very small parts is something we wish to incorporate into our design It is also very well marketed and described Price 15 16 C 6 Features So what should you look for in a mechanical pencil There sre a surprising variety of features to consider even sticking with only the most common variations a Lead Size may well be your first consideration For drawing and sketching you may want quite thick lead and some mechanical pencils are available with 4mm or thicker lead For writing many people prefer 0 9mm or 0 7mm with 0 5mm and 0 3mm becoming more popular for writing and drawing and certainly leading the way for technical drawing The thicker the lead the more likely it is to need sharpening but the thicker the line you can get from it and the easier it is to shade large areas If you like especially soft or hard lead grades you may be limited by the thicknesses your preferred grade of lead is available in 0 5mm usually has the widest choice and softer grades are more common in thicker leads If you write or draw aggressively thinner leads can be prone to snapping so you may prefer something thicker and stronger Modern leads are tougher than older leads though so if you used to find 0 5mm leads snapped for you years ago it might be worth another try with a modern lead like Pe
13. per day 1 A blood glucose test is performed by piercing the skin to draw blood typically from the fingertip This blood sample is then placed on a chemically active disposable strip which indicates the result either by a color change or by an electrochemical change which is measured by an electronic meter There are several key characteristics of modern blood glucose meters These include size test strips volume of blood sample testing speed display and memory data storage These testing devices are typically small hand held and battery powered with a liquid crystal display screen The electrochemistry of the testing strip is essential to the operation of the glucose monitor Test strips are the consumable one time use elements of these meters and a typical test trip is composed of the following 29 w w if glucose levels are Blood is put on monitor to check glucose levels A blood sample is taken glucose oxidase 32 potassium ferricyanide too high insulin is and 39 w w non reactive ingredients Each administered if strip contains a capillary to draw up blood from glucose levels One way to administer the patient and an enzyme electrode containing are too low insulin is through an glucose oxidase which can be reoxidized with carbohydrates ee a Q an excess of ferricyanide ion The concentration are ingested of glucose in the blood sample can be measured milligrams per deciliter mg dl since i
14. pr vour testina supplies and show vou how to save monev each month http www accu chek com us rewrite generalContent en US article ACCM general article 2542 htm Summary ACCU CHEK Comfort Curve Test Strips These test strips are curved to fit around your finger You don t need to put the blood on the test strip and users are instructed not to do this By simply placing the curved area next to the drop of blood on your finger the blood will be pulled into the yellow testing window MSRP 33 69 Comment These test strips are ideal in our design to draw the user s blood directly into the capillary situated in the middle of the test strip Our current design is implemented with the rotating disk of lances that comes up below where the test strip is positioned We re thinking by implementing these grooved test strips the lances can puncture through right by the capillary without the need to break through the strip itself 11 C Similar Applications C 1 Abbott Diabetes Care Help is now at hand Tour Account User ID Password How to use Place preloaded Sof Tact Sof Tact meters are no longer available However test strips can still be metar on the arm and i press stari button purchased at your local pharmacy or Diabetes Australia outlet sof Tact automatically obtains blood sample Product information and the product usage guide is provided below and begins to test le Sof Ta
15. the hydrogen peroxide and issues ane monitor uses the calibration value initially entered by the wearer to translate the signal into a glucose measurement The monitor then displays the glucose memory In addition to taking glucose readings the Glucovvatch monitor can sound alarms in response to results outside of high and low values selected fo feature can provide a method to reduce the risk of hyperglycemia abnormal increase of sugar in the blood and hypoglycemia abnormal decrease of sugar The Glucoy atch monitor should prove to be an excellent alternative to the painful pricking of traditional glucose reading methods For many concerned diabe Update on the GhicoWatch b AutoSensor The U S Food and Drug Administration FDA approved the use ofthe GlucoVVatch as a prescription device for adults with diabetes on March 22 2001 This glucose monitoring device of its kind currently approved by the FDA Diabetes and Glucose Monitoring Web Site Links GlucoWatch Biographer http www brookscole com chemistry d templates student resources 0030223180 garrettgrisham HotTopics GlucoWatch html Summary amp Comments Animas GlucoVVatch G2 Biographer system The glucowatch was an attempt at a non invasive glucose measuring device for patients who test their blood sugar levels multiple times per day The device used small electrical currents to draw glucose out of the arm and because of this caused mild to moderate skin irritation The wris
16. 500 blood glucose test results Individual results are processed within 5 seconds of testing Users are asked to either puncture at the fingertip or at alternate sites This meter employs a unique feature that eases the testing at these alternate sites When puncturing at the forearm or palm the user is asked to firmly press and hold the lancing device until the OneTouch AST TM Clear Cap changes color as blood collects beneath the skin This indicates to the user that there is sufficient blood for a good sample The OneTouch disposable lancing device has nine puncture depth settings to use for children and adults Proprietary disposable test strips are sold separately MSRP 19 99 Comments This is a small portable device This could be advantageous in terms of accessibility but may pose a problem to use for the elderly being so small We re not sure if it comes with its own lancing device as the webpage makes no mention of it Similar to the Accu Chek this device is also capable of alternate sites testing at the base of the thumb the forearm the upper arm and at the thigh Alternate site testing is definitely worth considering in our add on as it s less painful than at the fingertip This existing device also utilizes color change to indicate that enough blood has been loaded onto the test strip which is a reminder that our add on should have some sort of similar visual audio queue to serve the same function Getting Sta
17. 59 99 Comment This new meter by Ascensia can be served to a similar audience as our add on It utilizes a rotating disk for loading of test strips as to increase convenience Again though once the disk is loaded the strips still need to be discarded individually after usage Neither dexterity nor visual impairment is very well targeted since the patient still needs to manually bring the small exposed tip of the test strip to the test site Our add on instead will eliminate the small steps Furthermore the lances and the lancing device are also separate from the body of the meter unlike what we ve envisioned for our add on Nonetheless the disk design warrants further observation and can be used in our finalizing our design B 4 always feel close to you Even when we re 9 84 feet apart OneTouch Ping Meet the brains of this outfit OneTouch Ping is the intelligent glucose management system with one thing on its mind working together to help you perform at your best C om p are y A A F gt yo R H TM Like other insulin pump systems OneTouch Pins frees you from multiple daily injections and OneTouch Ping gives you the ability to quickly and easily adjust your insulin based on your body s immediate t th needs But unlike other systems OneTouch Ping delivers the double whammy in terms of smarts The competition pump is packed with unique capabilities that may be accessed both wirele
18. 95 15 k EZ Change Hearing Aid Battery Caddie Convenient Battery Caddie Energizer com Mozilla Firefox File Edit View History Bookmarks Tools Help o v Lo http www energizer com products hearing aid batteries consumer Pages battery caddy aspx F G Google o A Most Visited The World of Warcraft MM Gmail Inbox 228 s lt ype2Dia A Cemplicati a Columbia FDA gt CDR D Cybiocare FDA Appro 22 Blood gluc Z Identifying Z2 Self monit Z Importance Identifying _ Admission Basics Ho sueJPG G H Breaking Nu amp States Actiu amp Letters T EZ Cha x vv Energizer HOME BATTERYFINDER WHERE TO BUY ONLINE it 1 SEARCH PRODUCTS SPECIAL PROMOTIONS ENERGIZER BUNNY CENTER MEDIA CENTER LEARNING CENTER TECHNICAL INFO Home gt Products gt Hearing Aid Batteries gt Hearing Aid Wearers gt Energizer EZ Change Z220 27 ZChange m Energizer EZ Change Hearing Aid Batteries Hearing Aid Wearers Change your batteries without changing your plans Energizerg EZ Change The Energizer EZ Change hearing aid battery dispenser is simple enough for anyone to use Our portable battery dispenser makes it easy to replace your battery Energizer Tear Pack wherever and whenever you choose Cochlear Implant Batteries Small and in charge Audiologists Hearing Aid z 2 i Professionals About the
19. Care a Features and benefits of the Ascensia BREEZE 2 include Select New Locatiorkd u No Coding required No individual Test Strip Handling EA Bayer Links NEW Results in 5 seconds Bayer Global NEW Small sample 1uL required Investor Relations u Large easy to read display General Conditions of a Easy to use single function buttons Use u Automatic error detection and messaging Privacy Statement m Supports Diabetes Management Software u NEW 420 test memory m Automatic underfill detection ensures enough blood to perform each test successfully u Alternate Site Testing AST INDIVIDUALLY SEALED STRIPS FOR arthritis In fact the system even earned the Ease of Use Commendation from the Arthritis EXTENDED LIFE E EN The Ascensia BREEZE 2 system is ideal for people with limited dexterity due to Foundation US and Canada Done http www bayerdiabetes com 1110 htm Summary Ascensia CONTOUR BREEZES2 Glucose Monitoring System Device offers 5 second test time and is capable of storing 420 test entries Unique rotating 10 test disc and automatic strip filling action allows for easier handling for people with limited dexterity due to arthritis Meter automatically checks for errors and calibrates each time a new lot of test strips is used Device is cleared for multiple site testing including the finger forearm palm abdomen and thigh One microliter sample size required MSRP
20. Furniture gt Medical Lighting Wearable Digital Pulse Oximeter gt Otoscopes amp Nonin s WristOx 3100 is a small lightweight pulse oximeter designed to be worn Ophthalmoscopes comfortably on the patient s wrist Ideal for monitoring daily activities and for overnight studies the compact design of the WristOx is intended to give the patient greater freedom gt Pulse while improving patient compliance Right out of the box in the spot check mode the WristOx Oximeters Capnographs is a powerful tool to complete the picture add nVISION software and enable advanced WristOx features gt Scales gt Spirometers Nonin 3100 Wrist Oximeter Includes Two 1 5V Alkaline N cell Batteries gt Sterilizers Autoclaves gt Stress Test Systems http www medicaldevicedepot com Nonin WristOx 3100 W earable Digital Pulse Oximete p 3100 htm Summary amp Comments Nonin WristOx 3100 Wearable Digital Pulse Oximeter Device is a small lightweight pulse oximeter designed to be worn comfortably on the patient s wrist Ideal for monitoring daily activities and for overnight studies the compact design of the WristOx is intended to give the patient greater freedom while improving patient compliance The concept of a wearable device can be incorporated into our design ideas We like the automatic monitoring and ease of use this device offers MSRP 725 00 14 gt 7 gt CH a ios ican ts oucon E er Google Q Getti
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22. PORTABLE BLOOD GLUCOSE MONITORING IN VITRO DIAGNOSTIC DEVICES USING GLUCOSE OXIDASE DEHYDROGENASE OR HEXOKINASE METHODOLOGY VERSION 02 14 96 This is a flexible document presenting current guidance on the preparation of premarket notifications 510 k s for glucose in vitro diagnostics devices employing enzymatic methodologies t is based on current technology 2 clinical experience 3 previous submissions by manufacturers to the Food and Drug Administration FDA and 4 Safe Medical Devices Act of 1990 and regulations in the Code of Federal Regulations CFR So that we may revise the draft as necessary please send your comments to the add given below Joseph Hackett Ph D Associate Director http www fda gov Diabetes glucose html a Identification A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell tumors b Classification II FDA all devices require testing and accuracy check before marketing the FDA has approved one minimally invasive and one noninvasive device both devices however are not meant to serve as replacements for standard devices they re meant to provide additional information on top of standard measurements both also need to be re calibra
23. ates the process of blood glucose testing the user is still required to change individual test strips and lances between testings The meter is also much larger than other meters and somewhat awkward to handle for very small hands The internal lancing and blood application also means that the meter requires cleaning This device has been discontinued as of 2005 12 While diabetes is a chronic disease that has no known cure self monitoring of sugar levels by patients has transformed the management of diabetes over the last several years allowing diabetics to achieve and maintain specific glycemic goals Why is self monitoring so critical Without proper management of diabetes the disease can cause severe long term health complications including blindness kidney disease heart disease and nerve damage potentially leading to amputation or death Results of blood glucose monitoring are used to asses efficacy of therapy and to quide modifications in nutrition therapy exercise and medications to achieve the best possible blood glucose control By keeping the concentration of glucose blood inside a defined range 100 120 mg dL diabetics can lead normal lives Shown above at left are the daily accouterments of a diabetic glucose monitor lancet alcohol swabs syri needles insulin and emergency sugar for over injection of insulin Enter the GhicoWatch Monitor As previously described monitoring blood glucose levels all day is no small ordeal
24. ce were also developed by Ames Destrostix was available since 1965 and required a large sample of blood The color change in the strip corresponded with a color chart of varying levels of blood glucose The strip also required blood to be washed off one minute before inserting into the device to be measured The first articles in the medical literature on the home blood glucose monitoring were published in 1978 These demonstrated that patients could reliably measure their blood glucose levels at home and improve control of their glucose levels This led to the development of tvvo dominating meters for the home market Glucometer and Accu Check 1 As a result of the growing accuracy of domestic meters color changing test strips faded from popularity With the American Diabetes Association Food and Drug Administrations and National Institutes of Health s recommendations today s blood glucose device are designed to keep track of patient glucose levels over time help make day today decisions for glucose management and to recognize emergency situations Advanced meters today help in controlling glucose at a specific healthy level and adjusting glucose levels in response to changes in life style for individuals requiring medication Blood glucose monitoring is pivotal in the care of diabetes mellitus American Diabetes Association ADA recommends that most patients with type 2 diabetes test their blood glucose levels three or more times
25. cs are a very important consideration since target users are dexterity and or visually impaired Device must be accessible since elderly population has difficulty programming complex devices Device should be relatively small and rectangular to allow for easy transport Minimal training should be required since currently special nurses teach patients how to use glucose monitors prior to treatment plans Should cost less than 150 to manufacture and less than 200 to sell Reliability of data is essential since inaccurate measurements can result in patient mortality Life of product for user is approximately 5 10 years Life of product for company is approximately 2 years Data acquired should be saved over time and readily uploaded to computers Device should take less than 1 year to design since market is susceptible to new innovations in non invasive measurement techniques Device must not harm patients unnecessarily i e stab them to deep Device must deliver necessary volume of blood between 1 and 10 microliters depending on glucose monitor Device must add on to an existing glucose monitor and be separable to allow for portability 22 CC OISI 3 2 Apeaye UU U sey 5 1 61 YIM AemAue 1 Sulidno souls 5 M S UO ppE y u 10 ae u pue UO ppe y u s pol1 5
26. ct Blood Glucose Electrodes Product Information vie Sof Tact Diabetes Management System User Manual Beep sound signals the y countdown to results fay Clinically accurate blood ql cose results are given in just 20 seconds on s large back lit display http www abbottdiabetescare com au sof tac php Summary amp Comments MediSense Sof Tact Meters The Sof Tact Diabetes Management System is designed for in vitro diagnostic use use outside of the body It is for use only with fresh capillary whole blood from sites such as your forearm upper arm or the base of your thumb To use both test strip and standard lancet are placed within the unit Holding the Sof Tact against your skin you press a button that generates a slight vacuum lances the skin and applies the blood to the test strip This happens in about five to ten seconds and is completely automatic Once the test strip has a sample the unit generates a reading in 20 seconds Even though testing was relatively painless the Sof Tact is not the ideal alternative site monitor because of its relatively large blood volume requirement Obtaining the required 2 3 microliters from the forearm was not always easy Other alternative site meters require from one third to one tenth the volume of blood as the Sof Tact One reader who uses the Sof Tact reports that changing the lancet each time is essential to getting the correct blood volume Though the meter autom
27. ctly after a meal or exercise or when blood glucose level is low or falling It is also recommended that users confirm low readings from alternate sites with a fingerstick check before treating hypoglycemia A4 Who is the customer While the patient who uses the device is usually the primary customer many of them seek reimbursement from insurance companies To ensure our product is readily received into the market we should design it assuming the customer to be an insurance company A5 Who is the user Our target user is the elderly population living with diabetes that currently use conventional blood glucose monitors Specifically we hope users with visual and or dexterity impairments will prefer our device over currently distributed monitors 1 http www diabetesselfmanagement com articles Diabetes_Definitions Alternate Site Testing ni http www fda gov diabetes glucose html 12 15 http americandiabetes com AlternateSite htm B Existing Products B 1 EL See SE Te ACCUCHEK Mozilla Firefox o a S C http www accurchek com us rewrite content en_US 2 1 10 article ACCM_general_article_2353 htm H G Goog 22 Getting Started Latest Headines amp y LaundryView Online Laun New York Weather Fore ACCU CHEK ga Help Me Navigate E Meter Warranty Print this Page E mail this Page a Larger Type Home o ACCU CHEK Products gt ACCU CHEK Meter Systems ch M
28. e improved Q How much did your device cost A don t remember the exact cost but it should have been over 100 back then Q What do you think about our proposed device A think it ll be an improvement With the current device I m using I ve gotten so used to it that testing doesn t provide much of a problem for me and can tell how much blood need to have extracted However can certainly see the advantage of having something that provides more stationary support and sterilization Q What do you dislike about our proposed device A Well it s not something that dislike about it but for people like your grandfather who has a psychological fear of needles and getting injections can it be made less invasive or less painful Although your proposed device will provide better support and sterilization he ll still feel pain and knows that a needle is involved 18 D 2 Interview with Djalil Macki To further our understanding of how patients cope with their disease and use currently distributed blood glucose monitors we interviewed Djalil Macki a 62 year old male who has type l diabetes We first asked him a number of questions regarding how he uses his blood glucose monitor Since he uses the device multiple times per day he prefers using different fingers throughout the week so as not to bother one finger too much He also prefers using his device while seated at a table which he feels makes it easier to prick h
29. eter is ACCU CHEK Products ACCU CHEK Blood Glucose Meter Gah for You o ACCU CHEK Meter Systems Systems Use the meter selection tool and find out New Updated ACCU CHEK Click H Compact Plus System Our latest blood glucose testing systems have been designed with you ic ere in mind providing features that make it easier to test right the first time ACCU CHEK Aviva and take the pain out of testing Tired of plannin Other ACCU CHEK Meters ga your day aroun e Data Management Updated ACCU CHEK Compact Plus insulin Blood Glucose Meter Finally there s insulin therapy Purchase Accessories The first system to put all the pieces that revolves around you together Downloads Meet the 2 View detail ACCU CH Insurance Information View meter demo Spirit Insulin Pump Meter Warranty ACCU CHEK Compact Plus Blood Purchase Meter or Test Strips Glucose Meter About Diabetes All in one convenience Least pain 1 Monitorna 2 Treaimet View detail Mont Teaines A View meter demo Meals 8 Activity Caring for Others ACCU CHEK Aviva Blood Glucose bu SA abu ay 0 Meter Medical Professional ou Designed to make every strip count by S factinaticht tha firet time 2 b Done The ACCU CHEK Compact Plus System 15 Display Test On Off Button Release Button 1 Shows blood Slide and release this Slide to release the k sugar results button to turn
30. gers so you need to get a grip that suits your fingers Many people now like rubber grips and they are fast becoming the most common type available Some people still prefer the old fashioned knurled metal style and such grips do still exist especially in drafting pencils If you have trouble holding a thin pencil you may want to look for one with a wider grip like the Faber Castell Grip Plus Don t always assume though that rubber will be the most non slip surface some plastic or metal grips can be very grippy a Triangular Grips some people find a triangular grip section more comfortable and it can give you a bit more contact area with the pencil See the Faber Castell Grip range and Staedtler s Triplus pencils for some nice examples a Clip if you like to carry your pencil s in a shirt pocket a pocket clip may be important to you Most pencils come with a clip of some sort and in some cases it can be removed A clip will also stop the pencil from rolling off the desk when you put it down for a moment m Lead Advance all mechanical pencils have some way of moving the lead forward The most common is a button at the top of the pencil but there are other options available now a a Top Button still the most common and many pencils with other mechanisms also have a button on the top a Side Button a few pencils are available with a button on the side as well as or instead of the top This lets you advance the lead without movi
31. is finger and get a proper amount of blood onto the strip with relative ease Djalil is frequently frustrated with the occasional need to acquire a second sample when the first sample is insufficient He will occasionally reuse the lance but always ensures that he wipes it and washes his hands before taking a measurement When informed about the function of our device Djalil initially felt it not applicable to him since he does not have trouble pricking his finger for measurements However after further discussion he did say that it would be convenient to have a device in a stable location to automate his measurements He also felt a record of previous measurements would be beneficial He also said that since the device isn t readily portable he would still feel the need to have his current glucose monitor When asked if he would prefer a device that incorporates his existing glucose monitor he responded enthusiastically saying it would be useful to have all the results stored on one device overtime so he does not need to combine the data if he wanted to track his glucose level for a prolonged period for example when testing a new diet D 3 8 ege F Rp 4 5 0 i Patricia Kringas RN BSN MA Research Coordinator We interviewed Patricia Kringas RN at the Naomi Berrie Diabetes Center She was ecstatic over the comfort and ease of use plans we had detailed Along with agreeing that current devices needed preloaded drums or cart
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33. nd S UB y YOIUM dus ouoo B ue o p ldno sey sdins Jo eg JOASAUOD y AIOESOHON Sysip Ul s vuej v pue syoed 1 4 u Sd ns Buljpuey enpiAnpui p u y S CUILUI S o Ajay Wu 59uo ye 5 pue sdi s dninuu peo o Ayjiqedes su Cap o Z Ysa JNO si 511 uonduos q Z p pi ubis q SC UMO JNO JO 19 uu 10 93 9p e piInq o UDOUUD 51 se si uu B nsix o souinboy sobels eJu uudo A p UI US 31e 01 s besn saye ajpeau eoue Buis e Jo DUUIEIUIEIN OWI wes y Je p peo s uo ldilinul pue jqesods p osje jp u oup SU PHEW NIIP q IL 5 OWES 9U 10 16 oun e peoj UeD y 501 5 qesodsip Jo Jequunu y UO UU E SeoeRjd YyoIuM AAP U JO And oo q 1ou DIDOUS 11 ajqeyod q o Jue ui 511 sne5 g SUOOQ sdn buu oun ye uey in uled ss q o pies u q sey YSIUM wue v S ns 15 Buljpuey 104 p u y S EUIWWI S deu o urepe 501115 ot ldninu peol o l l qedeo woddns jqeyod P AOLd J IAAe SOld y AI9591 O p jipoui pue uo ppe y o p ldno
34. nfective complications as to minimize required maintenance The device will also display information in a format accessible to a wide audience of professionals and patients American Diabetes Association lt http www diabetes org about diabetes jsp gt DS2 RESEARCH A Problem Summary A 1 Diabetes Diabetes is a disorder that causes high blood sugar levels because the body does not adequately use or produce insulin a key hormone in the regulation of blood glucose levels Diabetes may be brought on by environmental factors or it may be hereditary Roughly 23 6 million Americans suffer from diabetes of which up to 5 7 million remain undiagnosed A further 57 million people are believed to have pre diabetes which is a less drastic form of the disease Diabetes refers to situations in which the body fails to respond to or create insulin which is a necessary hormone in glucose metabolism The disease s especially common in the elderly 23 1 of the population aged 60 and older have diabetes Diabetes is divided into two categories type 1 and type 2 Type 1 diabetes refers to patients whose body does not produce any insulin whereas type 2 refers to patients who either do not produce enough insulin or whose cells do not properly respond to normal insulin levels Many of the symptoms of diabetes are caused directly by high blood glucose levels rather than an insulin deficiency including increased fatigue blurry vision excessive
35. ng Started JLatest Headines 7LaundryView Online Laun ill New York Weather Fore HYSO U S A B CONFIDENCE HYGIENIC SOLUTIONS N PRODUCT TECHNOLOGY RESEARCH amp DEVELOPMENT PRIVATE LABEL INDUSTRY SOLUTIONS FAQ xy yo gitan People n Why Hyso Now About Hyso About Hyso About Hyso The Problem The Challenges HOME COMPANY PRESS TESTIMONIALS CONTACT Cleaning Matters UK DISTRIBUTOR CENTER rANING _HYSO can reduce the risk of cross contamination in the washroom loonina N http www hysonow com default aspx Summary amp Comments HYSO Automatic Door Handle Sanitizer The HYSO device contains a replaceable can of specially formulated QUAT based ULTRA CLEANER that depending on the selected interval setting can last for up to 3 months At the cusp of intervals a system of gears engages the patented stem pipe which releases a measured mist of the formula A proximity sensor detects motion within one meter of the unit ensuring the cessation of delivery thus eliminating the inadvertent spraying of a hand Also containing a light sensor the HYSO unit will power down if no ambient light is present Powered by 4 AA batteries the HYSO unit does not require special wiring into the main electric source making it easy to install and inexpensive to operate We re thinking of implementing something similar in our add on as to provide sterilization for the patients MSRP 59
36. ng the pencil as much usually using your thumb http VVVVVV Cultpens com acatalog Mechanical Pencils html Summary amp Comments Mechanical pencil constructs are similar in design to the lance loading mechanism in current devices We are identifying the best lance advancement mechanism and found an assortment of current mechanical pencil designs In considering for an optimal lance loading mechanism we are geared to finding one that is a one step snap loading in addition to being relatively easy to release These layouts are fitting for our design because they all entail simple clicks to advance the lead If we would expand upon these constructs and adapt them to a single rapid release along the entire length of the lance it would be advantageous for the user and us 17 D Interviews D 1 Grandmother Had to be translated from another language so the answers are not direct quotes Q How long have you had diabetes A had diabetes since you were born in 1987 so it s been a bit over two decades Q What is the most difficult part of having diabetes A think the most difficult part came when was first diagnosed with diabetes In China at the time the medicines weren t that great and didn t help much to manage glucose levels It really came down to self management and having to restrain myself from eating a lot of the foods that I ve been eating all my life The insulin was also not perfect whereupon it can lowe
37. ng to maintain sanitary conditions 20 E Safety Considerations and FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FDA Home Page CDRH Home Page Search A Z Index Ques FDA gt CDRH gt Guidance Documents gt Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase Dehydrogenase or Hexokinase Methodology Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase Dehydrogenase or Hexokinase Methodology DRAFT DOCUMENT This guidance document is being distributed for comment purposes only Clinical Chemistry and Toxicology Devices Branch Division of Clinical Laboratory Devices Office of Device Evaluation Draft released for comment on 2 28 97 Comments and suggestions regarding this draft document should be submitted within 60 days of the above release date to Joseph Hackett Ph D Associate Director Divisi Clinical Laboratory Devices HFZ 440 2098 Gaither Road Rockville MD 20850 Comments and suggestions received after this may not be acted upon by the Agency until th document is next revised or updated For questions regarding the draft document contact Dr Kaiser Aziz or Dr Joseph Hackett via phone 301 594 3084 or fax 301 594 5 U S DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Devices and Radiological Health REVIEW CRITERIA FOR ASSESSMENT OF
38. ntel s AIN m Lead Sleeve the part that surrounds the lead just behind the writing tip Either thin and round or conical a Thin round sleeves sre used in drafting pencils They give an easier view of the drawing area and allow the pencil to be used more accurately and easily with rules and ternplates Sometimes the sleeve can slide back so it gets pushed out of the way by the paper if you run low on lead If you use rules and templates a lot you may prefer a fixed sleeve but otherwise a sliding sleeve can be convenient a Pencils for writing usually have a conical sleeve which is less prone to getting bent or broken and less likely to poke through pockets and accidentally stab your own leg a Retractable Tip often referred to as Pocket Safe If you are going to carry a pencil in your pocket being able to retract the tip part inside the pencil can save your pocket and your leg from damage This is less important with conical sleeves than with thin sleeves m Lead Grade Indicator some pencils have an indicator you can set to show which grade of lead you have loaded in that pencil If you use a number of different pencils with different hardnesses of leads this could be very useful The indicator will usually only have a limited range of hardnesses listed so if you use unusually hard or soft leads you may not be covered by all pencils m Grip you need to be able to hold the pencil comfortably and without it slipping in your fin
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41. ower to you ONETOUCH Monitoring Learning Sharing Living The UltraMini A simple way to check your blood sugar Setting up your system Getting to know your OneTouch UltraMini Blood Glucose Meter and test strips Small Simple Now in 2 new color Limelight Pink Glow Silver Moon J new colors Purple Twilight and Blue Co OneTouch UltraMini Meter there s ney mg dL is the pre set unit of measure FRONT Display Edge to apply sample Confirmation window It just gives you a number fast Product tour d See the OneTouch Ultr Take the Product tour no Test port Up and down buttons Speed Insert test strip Turns the meter on or off speed y 4 here to turn meter Select or change information on for testing You nt BACK vvith battery door Battery door Contact bars nsert into test port Learn more about how food affects Simple Your OneTouch UltraMini Meter rx tans sauna comes complete with Simple Start Meter battery http www onetouchoffer com Summary TEST STRIP http VVVVVV Onetouchdiabetes comvultramini index himl One Touch UltraMini Blood Glucose Meter Device offers a low cost highly portable sleek design which allows for testing at the fingertip forearm or palm Requiring a 1 microliter sample of blood from the user the meter stores a maximum of
42. r the patient s blood glucose level to such an extent that it became dangerous to the patients Q What is the most challenging aspect of managing your diabetes A Up to the present day it would still be the dietary constraints Don t get me wrong it s not that love food but it s quite a burden to have to be careful about everything you eat Also you can t eat a lot per meal and have to divide your regular meals into multiple servings Q How many times a day do you have to check your glucose level A Once every 2 days or so when properly managed and inject insulin once daily If see that my glucose reading is too high on a particular day would watch my diet even more closely and may do additional tests during the day What device are you currently using A I m not too sure It s in English and can t read it Q Are you content with your current device and what do you think can be improved about it A Well I ve been using this device for almost a decade now and have gotten used to it did get a new device about a year or two ago but I m not really using it because of all the pre programming and setup required suppose it can be made more user friendly especially for people who have a language barrier Also cleaning the current device is problematic because it s difficult to open and expose the inside of the detector where the measurement strips are inserted suppose in that regard sterilization can b
43. ridges for extended testing she also liked our idea of improving lancing device comfort and handling through automation Additionally she liked our idea of pre loaded lances in the form of a drum or cartridge which would have superior handling compared to the current individual lances Nurse Kringas suggested by providing these lances in a compact user friendly container it would free the user from the high dexterity required to handles single lances Nurse Kringas also approved the finger guiding system of our add on and its universal appeal to patients with movement impairments and younger users She suggested that with a form of stationary support such as a table clamp patients with these dexterity impairments or weaker hands would be better able to test without losing their grip on the machine As she often deals with patients that have movement disorders she realized the importance that a firm stationary support would have high appeal to patients looking to be independent from assisted care Nurse Kringas also noted the need to allow the patient to rotate the finger within the machine so that the same exact site is used no more than a few times a week Often patients with diabetes rotate testing sites to avoid sores and infection to the testing area With the tight spacing and motorized components Nurse 19 Kringas was concerned with excess blood from elderly or younger users preventing efficient cleaning of the device She mentioned a pos
44. rted JLatest Headlines 7LaundryView Online Laun i New York Weather Fore DIABETES CARE Helping to improve the lives of people with diabetes daily e NEW APPLY BLOOD ICON BUTTON Products Diabetes Care Parents amp Caregivers Professi Ascensia CONTOUR Home x Products x CONTOUR TS gt Ascensia BREEZE2 Ascensia BRIO The New Ascensia BREEZE 2 E Blood Glucose Monitoring System Print Payl WA Ascensia 7 BUTTON Ascensia ELI L Using the new BREEZE 2 10 Test Disc NEW Ascensia ENTRUST N Ascensia MICROLET Ascensia BREEZE 2 r Ascensia MICROLET Just Fa sier REE PULL AND VACULANCE A Blood Glucose Moe PUSH HANDLE Ascensia The new BREEZE 2 system provides accuracy FOR TEST STRIP WinGlucofacts every time No coding required No individual strip manageme Software handling Just Easier BS d Download results from Bayer is committed to helping people with diabetes experience life s possibilities That s your meter to make your diabetes management why Bayer is introducing the new Ascensia BREEZE blood glucose monitoring 8 easier and more effective Bayer HealthCare system using the new BREEZE 2 10 test disc Justload and go Test 10 times without A LA Divisi M reloading and there is no coding required for easy accuracy every time CONVENIENT 99999 n 1 Sele ivision 10 TEST DISC 2222 aa reaa Diabetes
45. sible open air compartment would be better suited for maintenance and replacement of parts D 4 Dr Lauren Golden Endocrinologist We also interviewed Dr Lauren Golden at the Naomi Berrie Diabetes Center Dr Golden liked our ideas for a meter add on and applauded our idea to eliminate the individual placement of strips She suggested pre loading strips in the form of cartridges ranging from 15 20 to allow users easy loading As for the overall design she found our initial combination of automation and comfort to be unique and innovative since many current companies have not demonstrated a device to encompass an all in one system Dr Golden works with middle aged and older patients experiencing diabetes and found that our proposed device would be especially appealing to all people because of its simplicity and automation In regards to our finger massaging portion Dr Golden recommended massaging to occur before the procedure since massaging during blood extraction may create complications Taking her suggestion into practice we proposed the idea of a rough automated area that would produce a massaging area when the finger is placed on it When asked the question of when to sterilize or if to sterilize Dr Golden mentioned that repeated sterilization via alcohol pads actually dries the finger and causes long term issues with the patient skin Instead of sterilizing the finger she proposes that patients engage in active daily hand washi
46. size of a silver dollar the Energizer EZ Change dispenser fits in almost any pocket or purse The simple design of this hearing aid battery dispenser takes all FAQs the hassle and frustration out of handling such small batteries Straight from the Professionals Testimonials Features amp Benefits Additional Benefits See Energizer EZ Change in action A Magnet holds battery securely e Compact for easy carrying Watch the demonstration to discover just B Thumb Slide pushes out one battery Works with most hearying aid styles how simple Energizer EZ Change ata time and is available in every battery size makes changing your hearing aid C Clear Cover lets you view how many Battery goes straight from dispenser to batteries batteries are left hearing aid Dispenser has a contoured base e Dispenser keeps batteries fresh better grip protecting them from dust and dirt i Find Next Previous Highlight all 7 Match case d s s 8 Windows Explorer w EZ Change Hearing Downloads senior Design 2008 fist Autosaved Co M 9 Microsoft Office Zune y The Colbert Report LED Yahoo Search St 5 tH 9 04 AM http www energizer com products hearing aid batteries consumer Pages battery caddy aspx Summary amp Comments The Energizer EZ Change is a patented device that aids the elderly in the replacement of batteries for their hearing aids We expect
47. ssly by using the meter remote and manually And the meter remote with its full set of functions is designed to make your life with diabetes easier and more discreet In fact you can even dose your insulin from it t matches your body s needs like no other pump system OneTouch Ping gives you the smallest basal increment available 0 025 Uhr for more precise basal dosing 50 if you need 0 025 0 675 or 1 075 Uhr to perform at your best we can deliver Talk about fine tuned control It has serious communication skills The OneTouch Ping meter remote and the OneTouch Ping insulin pump communicate and shar information wirelessly In addition to testing blood glucose the meter remote can actually control pump functions This means that the meter remote can calculate a bolus then tell the pump to deliver it It also lets you view things like your basal rate without having to look at your pump It s smart about your carbs wo The meter remote can store the nutritional values of 500 of your favorite foods via CalorieKking for easy and accurate carb counting on the go Using ezManager Max software you can even customize the database or enter your own favorites like Mom chicken soup That means you can rest assured you re giving yourself the most precise insulin dose wherever whenever It s got beauty as well as brains The OneTouch Ping insulin pump has a flat panel color screen that uses the same screen technology as the
48. t is proportional to the total charge passing through the electrode Different models vary the amount of blood needed for accurate blood glucose measurements These can range from 0 3ul all the way to 10ul 2 http www fda gov Diabetes glucose html 16 10 http www mendosa com history htm S http www fda gov Diabetes glucose html 7 12 Bayer Ascensia Elite blood glucose test strips package insert 2002 http en wikipedia org wiki Glucose_meter A3 Fingertip vasculature and alternate site testing There has been a growing trend amongst modern blood glucose meters to allow for testing blood from alternative sites such as the upper arm forearm base of the thumb and thigh Alternate site testing is possible only with newer blood glucose meters that require a significantly small quantity of blood 0 6ul 1 0 ul to generate accurate blood glucose measurements Among the alternate site meters currently available are the Accu Chek Active and Compact marketed by Roche Diagnostics the Ascencia Breeze Contour DEX2 Elite and Elite XL Bayer the FreeStyle Freedom and FreeStyle Flash Abbott and the InDuo One Touch Ultra One Touch Ultra 2 and OneTouch UltraSmart LifeScan Each meter s user manual specifies what parts of the body can be used to obtain the blood sample Sampling blood from alternative site may be desirable but it has some limitations Glucose concentrations change rapidly after every meal injection of
49. t watch design is a good attempt to make the device convenient to use The device still required daily calibration using a conventional finger prick measurement and therefore did not eliminate the necessity for invasive measurements on a regular basis Suffering from inaccuracies in measurement especially at low glucose levels and expensive costs the sensor needs to be replaced every 13 hours and they cost approximately 5 00 each which is very expensive compared with test Strips the glucowatch has been discontinued Since the glucowatch did not rely on finger prick measurements it did not need to address the manual dexterity impairments we are focusing on 13 C 3 Nonin WristOx 3100 Wearable Digital Pulse Oximeter Mozilla Firerox lt gt 5 o On http Awww medicaldevicedepot com Nonin WristOx 3 100 Wearable Digital Pulse Oximete p 3100 htm Started Latest Online Laun New York Fore Search Home gt Pulse Oximeters Capnographs gt d Nonin WristOx 3100 Wearable Digital Pulse Oximeter Leem List Price 725 00 Our Price 675 00 You Save 50 00 Products gt Ambulatory BP Monitors Product Code 3100 x Audiometers amp Tympanometers gt Bone Densitometers gt C lpostopes gt Cryosurgery gt Defibrillators amp AED gt Distillers LARGER PHOTO A O eman a FRIEND EI gt Dopplers Additional Views gt Fetal Monitors S Fs Holter Systems Description gt Medical
50. tal confusion drowsiness and seizures In addition improper treatment may result in hypoglycemia a state of Blood glucose level milligrams per demiliter Hypoglycemia abnormally low blood sugar caused by side effects of 0 diabetes treatment that have a rapid effect on the 7am 12 noon 8 pm 7 am 12 noon 6 pm 7 brain SE 2 Glucose Meters 2 American Diabetes Association http www diabetes org about diabetes js American Diabetes Association http www diabetes org about diabetes js American Diabetes Association http www diabetes org about diabetes js American Diabetes Association http www diabetes org about diabetes js Diabetes Control and Complication Trial Research Group The effect of intensive treatment of diabetes in the development and progression of long term complications in insulin dependent diabetes mellitus New England Journal of Medicine 1993 329 977 Harris M Cowie C Howie L Self monitoring of blood glucose by adults with diabetes in the United States population Diabetes Care 1993 16 1116 Merck Diabetes Information http www merck com mmhe sec13 ch165 ch165a html Prior to the invention of blood glucose meters glucose levels were measured by color changing test strips The first blood glucose meter was developed by Anton Hubert Clemens The Ames Reflectance Meter ARM was primarily meant for use by physicians offices The test Strips used by the devi
51. ted frequently Safety Considerations the movement of the lance needle needs to be restricted beyond a certain threshold as to prevent puncturing the patients too deeply the restricting ring for inducing blood extraction needs to be capped at a maximum amount of force applied as to prevent causing the patients additional discomfort perhaps some sort of safety mechanism should be included as to prevent small children from insertion their fingers into the detector small removable parts are involved in the construction of the device and warrant further consideration i e how to prevent a small child from removing one of the pieces and ends up choking on it 24 DS3 Constraints and Specifications Constraints Must be usable by dexterity and or visually impaired patients Must not cause unnecessary pain to patients Must not be so large as to prohibit portability i e transport between home and work should not be inhibited Must reliably and accurately detect glucose levels Must be readily able to be sterilized Should be adjustable for use on different fingers Should be adjustable to allow for different pressures necessary to puncture skin of varying thickness Must be easily maintained and cleaned Must be priced competitively compared to existing glucose monitors Specifications Device must be testable using materials of varying toughness Device will be AC powered from wall outlet includes necessary transformers Ergonomi
52. thirst and hunger and frequent urination If high glucose levels remain untreated severe complications can occur Adults with diabetes have heart disease death rates 2 4 times higher than those without Long term complications include damage to the nervous system kidneys and eyes For instance diabetes is the lead cause of kidney failure accounting for 44 of new cases in 2005 Over 40 of diabetics also suffer from diabetic retinopathy limiting their visual abilities This can result in difficulties performing various tasks including blood glucose measurements as existing devices include a lot of small removable parts Furthermore approximately 1 in 2 elderly diabetic patients also suffer from arthritis leading to dexterity impairment that further complicates their working with existing glucose meters While there is no cure for diabetes proper monitoring of blood glucose levels along with changes to diet and lifestyle can greatly reduce the risk of complications in diabetic patients Treatments vary depending on the severity of the disease in an individual patient Self monitoring of blood glucose levels and treatment with insulin is one common treatment Approximately 40 of patients with type 1 diabetes perform blood glucose testing at least once per day It is important to monitor the patient s blood glucose closely Extremely high blood glucose levels can result in rapid dehydration causing acute complications such as men
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