CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
CONTOUR® NEXT EZ BGMS +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01548885
NCT01548885N/ACompleted
CompareCT.gov

Evaluation of Blood Glucose Meter Systems - NACT Study

Ascensia Diabetes Care·interventional·Posted Mar 8, 2012·Updated Feb 29, 2016

In Brief

A clinical study evaluating CONTOUR® NEXT EZ BGMS, FreeStyle Freedom Lite® BGMS, and 3 other interventions for Diabetes. Completed, enrolled 146 participants across 1 site.

Detailed Summary

The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2012
Enrollment StartMar 1, 2012
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 14.3 years ago

Interventions

CONTOUR® NEXT EZ BGMSdevice

Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of CONTOUR® NEXT EZ BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

FreeStyle Freedom Lite® BGMSdevice

Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of FreeStyle Freedom Lite® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

ACCU-CHEK® Aviva BGMSdevice

Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of ACCU-CHEK® Aviva BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

TRUEtrack® BGMSdevice

Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of TRUEtrack® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

OneTouch® Ultra®2 BGMSdevice

Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® Ultra®2 BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).