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

Introducing

BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM

Contents Co te ts

• Meter details & kit
• GlucoRx services, compliance & approvals
• Softw are
• Studies
• Cost savings

Cost savings

• Product w ebsite

M f t

• Manufacturer
• Contact details

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New GlucoRx blood glucose meter is an affordable, quality d t th t f ilit t i l t f di b t product that facilitates simple management of diabetes. Use GlucoRx test strips only for stress-free and precise testing.

no coding

• 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

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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

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GlucoRx Test strips

k i 2 25

GlucoRx Control solution

pack size 2 x 25s DT price £9.95, PIP code 349-1347

FAD-dependent glucose d h d (GDH dehydrogenase (GDH- FAD) enzyme for blood glucose measurement - strips avoid interference from blood oxygen from blood oxygen variation and also prevent maltose and galactose interference in blood samples

w arranty holders entitled to free solution

in blood samples.

entitled to free solution every 6 months

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GlucoRx Lancing device

• lancet ejection - avoids needle stick

injuries!

• durable construction

GlucoRx blood Lancets

• durable construction
• convenient pen shape
• adjustable tip allow s precise

customisation of lancet penetration

• easy operation

(single use)

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

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easy to use and grip

• pack size 200s

DT price £5.50, PIP code 349-1354

Services

– registered users entitled to a free battery and control solution every 6 months All GlucoRx products are CE/MHRA/FDA/DT approved

Compliance

All GlucoRx products are CE/MHRA/FDA/DT approved Full QA System; ISO 13485:2003 & ISO 9001:2008 requirements fulfilled

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European registrations p g

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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).

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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

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w as 75mg/dL.

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 t li i ll indicates clinically accuracy. 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. THEREFORE THE REQUIREMENTS

FOR ISO 15197 HAVE BEEN MET WITH THE GLUCORX METER.

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German study study

Investigation of the g measuring accuracy of 12 different systems for blood glucose self measurement according to DIN EN ISO 15197

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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. Th l f ti f th t t d t d th t R f d i b The normal function of the tested systems and that Reference devices became on each attempt day by the measurement suitable quality inspection samples examines.

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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%

• f the measured values w ere w ithin the given borders and w ould fulfill thereby

th t it i f th t d fi d b th t d d EN ISO the acceptance criteria for the system accuracy, defined by the standard EN ISO 15197, compared w ith the reference method used by the manufacturer.

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DRUG TARIFF

BIOSENSOR STRIPS

TO BE

March 2010

BIOSENSOR STRIPS - TO BE

READ ONLY WITH APPROPRIATE METER

BASIC PRICE (P)

FOR 50

GlucoRx testing strips 995

Savings of

Advantage Plus 1506 Aviva 1478 Contour 1485

Savings of up to 34%!

FreeStyle 1473 FreeStyle Lite 1473 GlucoMen LX Sensors 1444 OneTouch Ultra 1464 OneTouch Vita 1464 OneTouch Vita 1464 Optium Plus 1464 diabetes care the smart w ay

Savings of up to 39%!

DRUG TARIFF March 2010

LANCETS - STERILE, SINGLE-USE GAUGE BASIC PRICE (P)

FOR 200

GlucoRx Lancets (DiME) 0 31mm/30 gauge 550 (DiME) 0.31mm/30 gauge 550 FastClix (Roche Diagnostics) 0.3mm/30 gauge 902 FreeStyle (Abbott Labs Ltd) 0.5mm/25 gauge 694 Microlet 0.5mm/28 gauge 717 Microlet (Bayer Diagnostics) 0.5mm/28 gauge 717 Multiclix (Roche Diagnostics) 0.3mm/30 gauge 902 OneTouch Comfort (LifeScan UK) 0.20mm/33 gauge 717 OneTouch FinePoint (formerly FinePoint) (LifeScan UK) 0.5mm/25 gauge 702 OneTouch UltraSoft (LifeScan UK) 0.4mm/28 gauge 716 Softclix 0.4mm/28 gauge 735 (Roche Diagnostics Ltd) g g Softclix XL (Roche Diagnostics Ltd) 0.8mm/21 gauge 736 Thin Lancets (Abbott Labs Ltd) 0.36mm/28 gauge 708

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Website w w w.glucorx.co.uk

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For Professionals

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Manufacturer - TaiDoc Technology Corp.

• Taiw anese medical product

company established in 1998

• Became top blood glucose system

manufacturer in Taiw an in 2007 GLOBAL MARKET COVERAGE:

America 54% America 54% Europe 25% Middle East 10% Asia 7% T i 4% Taiw an 4%

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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

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DiME – distributor of GlucoRx products and medical

f disposable equipment for the pharmaceutical industry in the UK and throughout Europe 4 Wintonlea Monument Way West Woking Surrey Surrey GU21 5EN Customer services Phone: 01483 755133 Phone: 01483 755133 Fax: 01483 770195 E-Mail: info@ glucorx.co.uk Main contacts: Nilesh Nathw ani, Chris Chapman & Priya Thakur

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