B LOOD G LUCOSE M ONITORING S YSTEM Introducing
Contents • Meter details & kit • GlucoRx services, compliance & approvals • Softw are • Studies • Cost savings • Product w ebsite • Manufacturer • Contact details diabetes care the smart w ay
New GlucoRx blood glucose meter is an affordable, quality product that facilitates simple management of diabetes. Use GlucoRx test strips only for stress-free and precise testing. no coding 0.7µL blood volume; 7 seconds reaction time accurate & painless AST strip & lancet ejection 4 alarm reminders easy result indicators & ketone w arning result range: 1.1 - 33.3 mmol/L haematocrit range: 20 - 60% memory: 450 readings w ith day averages PC link facility size: 75L/45W/16Hmm, 40.8g w ithout CR2032 battery diabetes care the smart w ay
GlucoRx Kit includes... Blood glucose meter • Test strips • Control solution • Lancing device w ith clear cap • for AST Sterile lancets • Instructions • Log book • Warranty card • Carry case • diabetes care the smart w ay
GlucoRx Test strips GlucoRx Control solution pack size 2 x 25s DT price £9.95, PIP code 349-1347 These strips utilise glucose oxidase (GOD) enzymes for blood glucose measurement - blood sample types: fresh capillary w hole blood; AST; also no interference for patients w arranty holders on dialysis containing entitled to free solution maltose. every 6 months diabetes care the smart w ay
GlucoRx Lancing device • lancet ejection - avoids needle stick injuries! GlucoRx blood Lancets • durable construction (single use) • convenient pen shape • adjustable tip allow s precise customisation of lancet penetration • easy operation • clear cap for AST • very smooth, tri-bevel point • gauge: 0.31mm • sterile w ith x-ray irradiation • easy to use and grip • pack size 200s DT price £5.50, PIP code 349-1354 diabetes care the smart w ay
Services – registered users entitled to a free battery and control solution every 6 months Compliance All GlucoRx products are CE/MHRA/FDA/DT approved Full QA System; ISO 13485:2003 & ISO 9001:2008 requirements fulfilled diabetes care the smart w ay
diabetes care the smart w ay European registrations
PC link Use our Healthcare System to help manage your blood glucose: http://w w w.glucorx.co.uk/products-s.html ….. a personal computer application that enables upload, storage and analysis of test data from the GlucoRx meter through graphs and other softw are tools (request standard RS232 PC interface cable from DiME). diabetes care the smart w ay
diabetes care the smart w ay
Performance & Clinical studies The accuracy of the GlucoRx (TD-4230) blood glucose monitoring system has been evaluated according to ISO 15197. The two bold lines represent the acceptance criteria from this guideline. ASSESSMENT: 100% of the individual difference w as w ithin ± 15mg/dL w hen glucose concentration w as less than 75mg/dL. 98% of the individual difference w as w ithin ± 20% w hen glucose concentration w as ≧ 75mg/dL. diabetes care the smart w ay
Measurements from TD-4230 correlate w ell and match those values given by YSI- 2300 over a w ide range of glucose values. 98% of the individual results fall w ithin Zone A w hich indicates clinically accuracy. Also the precision [intermediate (day-to-day precision) and repeatability (w ithin-day precision)] of TD- 4230 w as examined and show ed acceptable precision. T HEREFORE THE REQUIREMENTS FOR ISO 15197 HAVE BEEN MET WITH THE G LUCO R X METER . diabetes care the smart w ay
German study Investigation of the measuring accuracy of 12 different systems for blood glucose self measurement according to DIN EN ISO 15197 diabetes care the smart w ay
Question: Due to the central meaning of blood glucose (BG) - self measurement for the monitoring and the adjustment of the intensified insulin therapy must exhibit the used blood glucose measuring systems a sufficiently high quality. The appropriate requirements on Blood glucose measuring systems for self-'s application w ith diabetes mellitus are stated in the European standard EN ISO 15197. Therefore the follow ing minimum accuracy must be fulfilled: 95% of the individual glucose measured values must, regarding the results of the Reference procedure, w ith glucose concentrations. Methodology: Became in January 2009 as w ell as betw een July and October 2009 altogether 12 blood glucose measuring systems of different manufacturers w ith CE-indications tested. Kapilläre blood tests of 100 different test persons w ere measured w ith 2 measuring instruments each of a type. Directly before and after the measurements w ith the systems w hich can be tested samples w ere removed for measurement w ith tw o reference procedures (Hexokinase method (HK), Hitachi 917, Roche DIAGNOSTICs and Glukoseoxidase method (GOD), YSI 2300 STAT PLUS, YSI Inc.). Here full blood concentrations w ere measured. For blood glucose measuring systems, w hich are calibrated on plasma concentrations, w ere converted the reference measured values into plasma-equivalent concentrations. The normal function of the tested systems and that Reference devices became on each attempt day by the measurement suitable quality inspection samples examines. diabetes care the smart w ay
Table 1: Organization of the pairs of measured values into the glucose concentration ranges on the basis the reference method YSI Table 2: Results of the blood glucose measurements after ISO standard (* : The manufacturer data to the reference method w ere converted. Goods no data available, GOD w as used.) Illustration 1: Test devices (v.l.n.r.: Screening BZ, Hämatokrit, reference 1, test device 1, test device 2, reference 2) Illustration 2: Strew ing diagrams for each of the tw elve devices. Along the x axis the BGReferenzmessw erte is indicated in mg/dl. On the y axis the BG-differences are in mg/dl betw een Equipment measured value and reference measured value laid on. The broken lines indicate the maximum deviations from ± 15, permissible after ISO standard, mg/dl and/or to ± 20%. Conclusion: About 7 of 12 tested blood glucose measuring systems at least 95% of the measured values w ere w ithin the given borders and w ould fulfill thereby the acceptance criteria for the system accuracy, defined by the standard EN ISO 15197, compared w ith the reference method used by the manufacturer. diabetes care the smart w ay
DRUG TARIFF B IOSENSOR S TRIPS B ASIC P RICE ( P ) February 2011 - to be read only w ith appropriate meter FOR 50 GlucoRx Test Strips 995 Advantage Plus 1517 Aviva 1489 Savings Contour 1485 of up to FreeStyle 1490 34%! FreeStyle Lite 1490 GlucoMen LX Sensors 1465 OneTouch Ultra 1475 OneTouch Vita 1481 Optium Plus 1480 diabetes care the smart w ay
Savings of up to 40%! DRUG TARIFF February 2011 B ASIC PRICE ( P ) L ANCETS - S TERILE , S INGLE -U SE G AUGE FOR 200 GlucoRx Lancets 0.31mm/30 gauge 550 BD-MicroFine + 0.20mm/33 gauge 632 FastClix 0.3mm/30 gauge 913 FreeStyle 702 0.5mm/25 gauge Microlet 0.5mm/28 gauge 717 909 Multiclix 0.3mm/30 gauge OneTouch Comfort 0.20mm/33 gauge 722 708 OneTouch FinePoint 0.5mm/25 gauge 740 Softclix 0.4mm/28 gauge Softclix XL 0.8mm/21 gauge 740 diabetes care the smart w ay
Website w w w.glucorx.co.uk diabetes care the smart w ay
diabetes care the smart w ay For Professionals
Manufacturer - TaiDoc Technology Corp. • Taiw anese medical product company established in 1998 • Became top blood glucose system manufacturer in Taiw an in 2007 G LOBAL MARKET COVERAGE : America 54% Europe 25% Middle East 10% Asia 7% Taiw an 4% diabetes care the smart w ay
Production capacity • Based on 8 hours a day w ith 1 production line per month. • Easily extendable: more production lines extension available, two-folds in one month diabetes care the smart w ay
DiME – distributor of GlucoRx products and medical disposable equipment for the pharmaceutical industry in the UK and throughout Europe 4 Wintonlea Monument Way West Woking Surrey GU21 5EN Customer services Phone: 01483 755133 Fax: 01483 770195 E-Mail: info@ glucorx.co.uk Main contacts: Nilesh Nathw ani, Chris Chapman & Priya Thakur diabetes care the smart w ay
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