Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01268488
First received: December 29, 2010
Last updated: September 14, 2012
Last verified: September 2012
Results First Received: September 14, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Diabetes
Intervention: Device: Ninja 2 Investigational Blood Glucose Meter

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Intended Users of the System

Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.

Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.


Participant Flow:   Overall Study
    Intended Users of the System  
STARTED     98  
COMPLETED     93  
NOT COMPLETED     5  
Adverse Event                 3  
Physician Decision                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Users of the System

Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.

Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.


Baseline Measures
    Intended Users of the System  
Number of Participants  
[units: participants]
  98  
Age  
[units: years]
Mean ( Full Range )
  50.8  
  ( 19 to 79 )  
Gender  
[units: participants]
 
Female     53  
Male     45  
Region of Enrollment  
[units: participants]
 
United States     98  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method   [ Time Frame: 2 hours ]

2.  Secondary:   Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 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 ]

4.  Secondary:   Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
It was decided that this investigational BG monitoring system would not be part of a regulatory submission. It will not proceed to market.


  More Information
  Hide More Information

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: Maria Viggiani
Organization: Bayer Healthcare, Diabetes Care
phone: 914-333-6280
e-mail: maria.viggiani@bayer.com


No publications provided


Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01268488     History of Changes
Other Study ID Numbers: CTD-2010-008-02
Study First Received: December 29, 2010
Results First Received: September 14, 2012
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board