Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates
Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates
1 other identifier
interventional
162
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Dec 2012
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
April 9, 2014
CompletedFebruary 15, 2017
December 1, 2016
2 months
December 20, 2012
February 28, 2014
December 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value
Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
30 minutes
Secondary Outcomes (1)
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
30 minutes
Other Outcomes (2)
Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals)
30 minutes
Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals)
30 minutes
Study Arms (1)
Neonates 'Left-over' Blood Samples
EXPERIMENTALBlood 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. Two left-over samples could be obtained from a single neonate. Laboratory professionals tested the BG concentration using three Bayer Blood Glucose Monitoring Systems (BGMS): Contour® NEXT BGMS, Contour® PLUS BGMS, and Contour® Next EZ BGMS.
Interventions
Lab professionals tested the BG concentration using Contour® NEXT BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Lab professionals tested the BG concentration using Contour® PLUS BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Lab professionals tested the BG concentration using Contour® Next EZ BGMS (Blood Glucose Monitoring System). All meter BG results were compared with plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Eligibility Criteria
You may qualify if:
- Routine blood samples (heelstick) collected from neonates (less than 30 days of age).
- A portion of the samples (approximately 10%) will be from subjects \<24 hours old.
- A portion of the samples (at least 10%) will be from subjects in the NICU.
- Sample blood volume must be sufficient to complete investigational testing in addition to prescribed testing.
You may not qualify if:
- Samples from babies \>=30 days of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jane Wallace
- Organization
- Ascensia Diabetes Care
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis J Dietzen, PhD, DABCC
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
December 25, 2012
Study Start
December 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 15, 2017
Results First Posted
April 9, 2014
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share