CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
Bayer G3 / Tatsu System +5 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/NCT01614613
NCT01614613N/ACompleted
CompareCT.gov

Clinical Evaluation of Bayer G3 / Tatsu System and BGMs From Other Companies

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

In Brief

A clinical study evaluating Bayer G3 / Tatsu System, Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips, and 4 other interventions for Diabetes. Completed, enrolled 146 participants across 1 site.

Detailed Summary

The purpose of this study was to test the performance of an investigational Bayer Blood Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was to obtain glucose samples from subjects with diabetes across the meter operating ranges. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). All lancings and testing were performed by study staff.

Study Details

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

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartMay 1, 2012
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.1 years ago

Interventions

Bayer G3 / Tatsu Systemdevice

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Stripsdevice

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Freestyle Lite® Meter and Test Strips with ZipwikTM tabsdevice

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Stripsdevice

Study staff performed Blood Glucose (BG) tested with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

One Touch® VerioTM Pro/One Touch® VerioTM Test Stripsdevice

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Truetrack® Meter/Truetrack® Test Stripsdevice

Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).