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User Study for Enhanced Meter Feature

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.
 
ClinicalTrials.gov Identifier: NCT01889355
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
AgaMatrix, Inc.

Brief Summary:

This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.

This study will evaluate a user's ability to use the enhanced meter feature.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: AgaMatrix Blood Glucose Monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
Study Start Date : January 2014
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Enhanced meter feature usability
Home diabetes monitoring by patient using provided blood glucose monitoring system.
Device: AgaMatrix Blood Glucose Monitor



Primary Outcome Measures :
  1. Enhanced Meter Feature Usability [ Time Frame: 4 weeks ]
    The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

IC 1. Age of subject is 18 years or older

IC 2. Type I or type II diabetes inclusive of the following populations:

  1. Mixed insulin therapies
  2. Basal insulin therapies
  3. Bolus insulin therapies
  4. CSII therapies
  5. MDI therapies
  6. Non-insulin diabetic treatments (oral and injectable)
  7. Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently

Exclusion criteria EC 1. Pregnant EC 2. Hct <20 or >60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.

EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

EC 9. Previous experience using the MyStar Extra BGMS


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889355


Locations
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United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Sponsors and Collaborators
AgaMatrix, Inc.
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Responsible Party: AgaMatrix, Inc.
ClinicalTrials.gov Identifier: NCT01889355    
Other Study ID Numbers: AGAFPGM01
First Posted: June 28, 2013    Key Record Dates
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018
Last Verified: March 2014
Keywords provided by AgaMatrix, Inc.:
diabetes
glucose
glucometer