N/A
Completed N=162
Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates
Source: ClinicalTrials.gov NCT01756274 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value — 100.0; 99.5; 99.5 percentage of Blood Glucose Results
Summary
The purpose of this study was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000 instrument).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value |
100.0; 99.5; 99.5 | — |
| SECONDARY Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value |
99.5; 99.1; 99.1 | — |
Eligibility Criteria
Inclusion Criteria
- Routine blood samples (heelstick) collected from neonates (less than 30 days of age).
- A portion of the samples (approximately 10%) will be from subjects =30 days of age
Data sourced from ClinicalTrials.gov (NCT01756274). 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.