Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Contour® NEXT BGMS; Device: Contour® PLUS BGMS; Device: Contour® Next EZ BGMS

• Registration Number: NCT01756274
• Lead Sponsor: Ascensia Diabetes Care

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-25
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-02-28
• Results First Submitted QC: 2014-02-28
• Results First Posted: 2014-04-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 <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.

Exclusion Criteria

• Samples from babies >=30 days of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonates 'Left-over' Blood Samples	Contour® Next EZ BGMS	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. 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.
Neonates 'Left-over' Blood Samples	Contour® NEXT BGMS	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. 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.
Neonates 'Left-over' Blood Samples	Contour® PLUS BGMS	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. 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.

Primary Outcome Measures

Name	Time	Method
Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value	30 minutes	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).

Secondary Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States