Status:
COMPLETED
Accuracy 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 between Healthcare Professional visits. This information may facilitate...
Eligibility Criteria
Inclusion
- Type I or type II diabetes inclusive of the following populations:
- Mixed insulin therapies
- Basal insulin therapies
- Continuous subcutaneous insulin infusion therapies
- Multiple daily injection therapies
- Non-insulin diabetic treatments (oral and injectable)
- Life style (exercise and diet) diabetes management
- New diagnosis of diabetes
- Non diabetics
- Able to speak and read English proficiently
- Subjects must be willing to:
- once a month, perform a 7 point blood glucose profile over the course of one day
- perform fasting blood glucose tests every day
- complete baseline and follow-up questionnaires
- consent to baseline HbA1c assays
Exclusion
- Pregnant
- Hct \<20 or \>60
- Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
- Homeless
- Incarcerated
- Mentally ill
- Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.
- Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01885546
Start Date
July 1 2013
End Date
December 1 2013
Last Update
July 8 2015
Active Locations (1)
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1
MassResearch, LLC
Waltham, Massachusetts, United States, 02453