Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Diabetes Clinical Trial

Official title:

Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756274
• Other study ID #: CTD-2010-009-03
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: January 29, 2016
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Contour® NEXT BGMS
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).
• Contour® PLUS BGMS
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).
• Contour® Next EZ BGMS
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).

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)	30 minutes	No
Other	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)	To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)	30 minutes	No
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	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	No
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	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	No