N/A
N=162
Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01756274 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: 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 percentage of Blood Glucose Results
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contour® NEXT BGMS (Device); Contour® PLUS BGMS (Device); Contour® Next EZ BGMS (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Feb 2013
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 | — |
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).
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.