User Study for Enhanced Meter Feature



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/8/2018
Start Date:January 2014
End Date:March 2014

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Trial Summary
Trial Overview
Inclusion Criteria

User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS

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.


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
We found this trial at
1
site
Atlanta Diabetes Associates
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
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