Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Contour® NEXT BGMS; Device: Contour® PLUS BGMS; Device: Contour® Next EZ BGMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756274

CTD-2010-009-03

Details and patient eligibility

About

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).

Enrollment: 162 patients

Sex: All

Ages: Under 30 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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162 participants in 1 patient group

Neonates 'Left-over' Blood Samples

Experimental group

Description:

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.

Treatment:

Device: Contour® NEXT BGMS

Device: Contour® Next EZ BGMS

Device: Contour® PLUS BGMS