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NCT01614613 · ClinicalTrials.gov registry record · NA
Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting
A NA study, sponsored by Ascensia Diabetes Care.
- Completed
- Registry status
- NA
- Development phase
- 146
- Enrollment target
NCT01614613: Completed NA study, sponsored by Ascensia Diabetes Care.
NCT01614613 is a NA study that has completed, run by Ascensia Diabetes Care. The registered enrollment target is 146 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01614613, a NA study, has completed, sponsored by Ascensia Diabetes Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 146 participants
- Enrollment target
Study 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.
Primary Outcome
Using samples with BG \< 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value.
Interventions
- DEVICE Bayer G3 / Tatsu System
- DEVICE Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips
- DEVICE Freestyle Lite® Meter and Test Strips with ZipwikTM tabs
- DEVICE OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips
- DEVICE One Touch® VerioTM Pro/One Touch® VerioTM Test Strips
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT01614613 record still lists
NCT01614613 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Bayer G3 / Tatsu System is the first listed.
NCT01614613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01614613 about?
NCT01614613 is a clinical study titled "Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting". 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 collec...
What is the current status of trial NCT01614613?
This trial is currently completed. It is a NA study. The enrollment target is 146 participants. The study started on 2012-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01614613?
The interventions under investigation include: Bayer G3 / Tatsu System (DEVICE), Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips (DEVICE), Freestyle Lite® Meter and Test Strips with ZipwikTM tabs (DEVICE), OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips (DEVICE), One Touch® VerioTM Pro/One Touch® VerioTM Test Strips (DEVICE).
Who is sponsoring clinical trial NCT01614613?
This trial is sponsored by Ascensia Diabetes Care, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01614613's enrollment target sits among peer trials
146 704th of 2000 higher than 1,296 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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