OneTouch® Ultra® Brand Test Strips: Meter

OneTouch® Ultra® Brand Test Strips: Meter

OneTouch Ultra Brand Test Strips:
Meter equivalence and proven accuracy
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Introduction
Since the introduction of the OneTouch® Ultra® System
in 2000, published evaluations have shown that the
system provides accurate blood glucose results in the
hands of patients and healthcare professionals.1– 6
In one clinical evaluation, more than 50,000 blood
glucose samples were tested on 609 batches of test
strips over a 5-year period, demonstrating a consistent,
high level of accuracy (Figure 1).
Figure 1. OneTouch® Ultra® Test Strips: Proven accuracy over 5 years
Consensus error grid performance,7
2001–2006, n=50,077
Zone Analysis
Zone A: 98.5%
Zone B: 1.5%
Zone C: 0.0% (5 of 50,077 results)
Zones D and E: 0.0% (0 results)
Introduced in 2003, the OneTouch® UltraSmart®
System is an integrated glucose meter and electronic
logbook. The OneTouch® UltraSmart® Meter uses the
same test strip as the OneTouch® Ultra® Meter. Previous
testing has shown that results obtained using the
OneTouch® UltraSmart® Meter are equivalent to those
obtained using the OneTouch® Ultra® Meter.8
The OneTouch® Ultra® 2 System offers enhanced
functionality (e.g., before- and after-meal flags and
averages) for evaluating meal-related test results. All
OneTouch® Ultra® System meters use OneTouch® Ultra®
Test Strips. The purpose of this report is to present the
findings from meter equivalence testing conducted with
the OneTouch® Ultra® 2 Meter.
Procedure
• Blood collected from a single donor was adjusted
to five different glucose concentrations: 20, 70,
240, 450, and 600 mg/dL (1.1, 3.9, 13.3, 25.0,
and 33.3 mmol/L).
• Testing was conducted using 16 OneTouch® Ultra®
Meters and 16 OneTouch® Ultra® 2 Meters using a
single batch of test strips.
zone a: No effect on clinical action
zone b: Altered clinical action, little or no effect on
clinical outcome
zone c: Altered clinical action, likely to affect clinical
outcome
zone d: Altered clinical action, could have significantly
medical risk
zone e: Altered clinical action, could have dangerous
consequences
• Each blood sample was tested five times on each
meter.
• Using the OneTouch® Ultra® Meter as the control,
the mean bias of the OneTouch® Ultra® 2 Meter
was determined and compared against previously
determined acceptance criteria.
Results
The results show that the mean bias between the
OneTouch® Ultra® 2 Meter and the OneTouch® Ultra®
Meter is within the acceptance criteria of 3 mg/dL
(0.17 mmol/L) or 4% (Table 1).
Table 1. Mean Bias for OneTouch® Ultra® 2 compared to OneTouch® Ultra®
Glucose level mg/dL (mmol/L)
Bias from OneTouch® Ultra® mg/dL (mmol/L), or % *
20 (1.1)
1.23 (0.07)
70 (3.9)
0.98 (0.05)
240 (13.3)
0.49%
450 (25.0)
1.07%
600 (33.3)
0.10%
* For glucose M 70 mg/dL (3.9 mmol/L), bias is reported in mg/dL (mmol/L).
For glucose 70 mg/dL, bias is reported in %.
Conclusion
• Consistent accuracy, as shown by 5 years of clinical
testing, and meter-demonstrated equivalency allow
patients and healthcare professionals to have
greater confidence and trust in the OneTouch® Ultra®,
OneTouch® UltraSmart®, and OneTouch® Ultra® 2 Systems.
References
1. Weinzimer SA, Beck RW, Chase HP, Buckingham BA, Tamborlane
WV, Kollman C, Coffey J, Xing D, Ruedy KJ; Diabetes Research in
Children Network Study Group. Accuracy of newer-generation
home blood glucose meters in a Diabetes Research in Children
Network (DirecNet) inpatient exercise study. Diabetes Technol Ther.
2005 Oct;7(5):675–80.
2. The Diabetes Research in Children Network (DirecNet) Study Group.
A multicenter study of the accuracy of the OneTouch® Ultra® home
glucose meter in children with type 1 diabetes. Diabetes Technol
Ther. 2003;5(6):933–41.
3. Demers J, Kane MP, Bakst G, Busch RS, Hamilton RA. Accuracy of
home blood glucose monitors using forearm samples: FreeStyle®
versus OneTouch® Ultra®. Am J Health Syst Pharm. 2003 Jun
1;60(11):1130 –5.
4. Bina DM, Anderson RL, Johnson ML, Bergenstal RM, Kendall DM.
Clinical impact of prandial state, exercise, and site preparation on
the equivalence of alternative-site blood glucose testing. Diabetes
Care. 2003 Apr;26(4):981–5.
5. Jungheim K, Koschinsky T. Glucose monitoring at the arm:
risky delays of hypoglycemia detection. Diabetes Care. 2002
Jun;25(6):956–60.
6. Ellison JM, Stegmann JM, Colner SL, Michael RH, Sharma MK, Ervin
KR, Horwitz DL. Rapid changes in postprandial blood glucose
produce concentration differences at finger, forearm, and thigh
sampling sites. Diabetes Care. 2002 Jun;25(6):961– 4.
7. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus
error grid to evaluate the clinical significance of inaccuracies
in the measurement of blood glucose. Diabetes Care. 2000;
23(8):1143–1148.
8. LifeScan, Inc. Clinical accuracy and user acceptance of the
OneTouch® UltraSmart® Blood Glucose Monitoring System.
Milpitas (CA); 02/2003. AW 058-874A.
www.LifeScan.com
© 2006 LifeScan, Inc. Milpitas, California 95035 05/2006 AW 087-308A Printed in the USA