Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01614613
First received: May 13, 2012
Last updated: September 9, 2013
Last verified: September 2013
Results First Received: June 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes
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
Device: Truetrack® Meter/Truetrack® Test Strips

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intended BGM Users Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.

Participant Flow:   Overall Study
    Intended BGM Users  
STARTED     146  
COMPLETED     146  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intended BGM Users Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips

Baseline Measures
    Intended BGM Users  
Number of Participants  
[units: participants]
  146  
Age  
[units: years]
Mean ( Full Range )
  53.0  
  ( 21 to 80 )  
Gender  
[units: participants]
 
Female     68  
Male     78  
Region of Enrollment  
[units: participants]
 
United States     146  



  Outcome Measures
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1.  Primary:   MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)   [ Time Frame: 6 hours ]

2.  Secondary:   MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL   [ Time Frame: 6 hours ]

3.  Secondary:   MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL   [ Time Frame: 6 hours ]

4.  Secondary:   Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)   [ Time Frame: 6 hours ]

5.  Secondary:   Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carmine Greene
Organization: Bayer Healthcare, Diabetes Care
phone: 574-257-3040
e-mail: carmine.greene@bayer.com


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01614613     History of Changes
Other Study ID Numbers: CTD-2010-009-02
Study First Received: May 13, 2012
Results First Received: June 30, 2013
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board