Introducing B LOOD G LUCOSE M ONITORING S YSTEM B LOOD G LUCOSE M - PowerPoint PPT Presentation

Introducing B LOOD G LUCOSE M ONITORING S YSTEM B LOOD G LUCOSE M ONITORING S YSTEM

Contents Co te ts • Meter details & kit • GlucoRx services, compliance & approvals • Softw are • Studies • Cost savings Cost savings • Product w ebsite • Manufacturer M f t • Contact details diabetes care the smart w ay

New GlucoRx blood glucose meter is an affordable, quality product that facilitates simple management of diabetes. d t th t f ilit t i l t f di b t Use GlucoRx test strips only for stress-free and precise testing. no coding o cod g 0.7µL blood volume; 7 seconds reaction time accurate & painless AST strip & lancet ejection 4 alarm reminders easy result indicators & ketone w arning 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, 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 k i 2 25 DT price £9.95, PIP code 349-1347 FAD-dependent glucose d h d dehydrogenase (GDH- (GDH FAD) enzyme for blood glucose measurement - strips avoid interference from blood oxygen from blood oxygen variation and also prevent maltose and w arranty holders galactose interference entitled to free solution entitled to free solution in blood samples in blood samples. every 6 months diabetes care the smart w ay

GlucoRx Lancing device • lancet ejection - avoids needle stick injuries! GlucoRx blood Lancets • durable construction • durable construction (single use) • convenient pen shape • adjustable tip allow s precise customisation of lancet penetration • easy operation 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 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 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 g p

PC link Use our Healthcare System to help manage your blood glucose: y p g y g http://w w w.taidoc.com/GlucoRX_HealthCareMgtSys_V3.04_2010 0721.exe ….. a personal computer application that enables upload, storage and analysis of test data from the GlucoRx meter g y 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 y ( ) g g y 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 i di indicates clinically accuracy. t li i ll Also the precision [intermediate (day-to-day precision) and repeatability p ) p y (w ithin-day precision)] of TD- 4230 w as examined. TD-4230 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 study Investigation of the g 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 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 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), p ( ( ), 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 Th l f ti f th t t d t d th t R f d i b 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 ) 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 th t it i f th t d fi d b th t d d 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 - TO BE B IOSENSOR S TRIPS TO BE March 2010 B ASIC P RICE ( P ) READ ONLY WITH FOR 50 APPROPRIATE METER GlucoRx testing strips 995 Advantage Plus 1506 Aviva 1478 Savings of Savings of Contour 1485 up to 34%! FreeStyle 1473 FreeStyle Lite 1473 GlucoMen LX Sensors 1444 OneTouch Ultra 1464 OneTouch Vita OneTouch Vita 1464 1464 Optium Plus 1464 diabetes care the smart w ay

Savings of up to 39%! DRUG TARIFF March 2010 B ASIC PRICE ( P ) L ANCETS - S TERILE , S INGLE -U SE G AUGE FOR 200 GlucoRx Lancets (DiME) (DiME) 0 31mm/30 gauge 0.31mm/30 gauge 550 550 FastClix (Roche Diagnostics) 0.3mm/30 gauge 902 FreeStyle 0.5mm/25 gauge 694 (Abbott Labs Ltd) Microlet Microlet 0.5mm/28 gauge 0.5mm/28 gauge 717 717 (Bayer Diagnostics) 902 Multiclix 0.3mm/30 gauge (Roche Diagnostics) 717 OneTouch Comfort 0.20mm/33 gauge (LifeScan UK) OneTouch FinePoint (formerly FinePoint) 0.5mm/25 gauge 702 (LifeScan UK) OneTouch UltraSoft 0.4mm/28 gauge 716 (LifeScan UK) 735 Softclix 0.4mm/28 gauge g g (Roche Diagnostics Ltd) 736 Softclix XL 0.8mm/21 gauge (Roche Diagnostics Ltd) 708 Thin Lancets 0.36mm/28 gauge (Abbott Labs Ltd) 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% America 54% Europe 25% Middle East 10% Asia 7% T i Taiw an 4% 4% diabetes care the smart w ay

Production capacity • • Based on 8 hours a day w ith 1 production line per month 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