Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Completed · Not applicable

Conditions studied: Diabetes

In brief

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).

Key facts

Study ID

NCT01756274

Run by

Ascensia Diabetes Care

People needed

162

Starts

2012-12-01

Expected to finish

2013-02-01

Last updated by the study team

2017-02-15

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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