N/A
Completed N=112
Evaluation of Blood Glucose Monitoring Systems
Source: ClinicalTrials.gov NCT01699763 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range — 2.7; 10.8; 6.4 Percent Difference
Summary
The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
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 |
2.7; 10.8; 6.4 | — |
| SECONDARY MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL) |
2.63; 14.92; 8.81 | — |
| SECONDARY MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL) |
2.66; 8.76; 4.52 | — |
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 (NCT01699763). 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. Informational only — not medical advice.