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Performance of a New Glucose Meter System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264016
First Posted: December 21, 2010
Last Update Posted: February 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ascensia Diabetes Care
Results First Submitted: April 4, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Diabetes
Intervention: Device: Investigational Blood Glucose Monitoring System

  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
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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 Users of the Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system.

Participant Flow:   Overall Study
    Intended Users of the Monitoring System
STARTED   96 
COMPLETED   94 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Felt faint at sight of blood                1 



  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.
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Reporting Groups
  Description
Intended Users of the Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.

Baseline Measures
   Intended Users of the Monitoring System 
Overall Participants Analyzed 
[Units: Participants]
 93 
Age 
[Units: Years]
Mean (Full Range)
 
Mean age (range of ages)   37.8 
 (18 to 73) 
Gender [1] 
[Units: Participants]
 
Female   47 
Male   46 
[1] 94 subjects completed study; 93 subjects had evaluable blood glucose data as described in outcome measure results
Region of Enrollment [1] 
[Units: Participants]
 
United States   93 
[1] One subject withdrew voluntarily; one subject was withdrawn. 94 subjects completed the study.


  Outcome Measures
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1.  Primary:   Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method   [ Time Frame: 2 hours ]

2.  Primary:   Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method   [ Time Frame: 2 hours ]

3.  Secondary:   Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)   [ Time Frame: 2 hours ]


  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: Jane Wallace
Organization: Ascensia Diabetes Care
phone: 574-257-3063
e-mail: jane.wallace@ascensia.com



Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01264016     History of Changes
Other Study ID Numbers: CTD-2010-004-01
First Submitted: December 18, 2010
First Posted: December 21, 2010
Results First Submitted: April 4, 2012
Results First Posted: May 1, 2012
Last Update Posted: February 29, 2016