N/A
N=146
Comparison Evaluation of Blood Glucose Meter Systems
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01548885 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range — 4.7; 6.3; 18.3; 23.4 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CONTOUR® NEXT EZ BGMS (Device); FreeStyle Freedom Lite® BGMS (Device); ACCU-CHEK® Aviva BGMS (Device); TRUEtrack® BGMS (Device); OneTouch® Ultra®2 BGMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range |
4.7; 6.3; 18.3; 23.4; 26.2 | — |
| SECONDARY MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) |
0.7; 2.5; 18.3; 22.4; 33.2 | — |
Summary
The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.
Eligibility Criteria
Inclusion Criteria
- Males and females
- 18 years of age or older
- Willing to complete all study procedures
Exclusion Criteria
- Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
- Hemophilia or any other bleeding disorder
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01548885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.