Status:
COMPLETED
User Study for Enhanced Meter Feature
Lead Sponsor:
AgaMatrix, Inc.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 facilit...
Eligibility Criteria
Inclusion
- 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:
- Mixed insulin therapies
- Basal insulin therapies
- Bolus insulin therapies
- CSII therapies
- MDI therapies
- Non-insulin diabetic treatments (oral and injectable)
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01889355
Start Date
January 1 2014
End Date
March 1 2014
Last Update
August 6 2018
Active Locations (1)
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1
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318