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Clinical Trials/NCT01885546
NCT01885546
Completed
Not Applicable

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

AgaMatrix, Inc.1 site in 1 country133 target enrollmentJuly 2013
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ConditionsDiabetes Mellitus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
AgaMatrix, Inc.
Enrollment
133
Locations
1
Primary Endpoint
User's ability to obtain the enhanced meter feature
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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 increased dialogue between patient and Healthcare Professionals and can remind patients of the importance of glycemic control.

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

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Hct \<20 or \>60
  • •Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott)
  • •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.

Outcomes

Primary Outcomes

User's ability to obtain the enhanced meter feature

Time Frame: 16 weeks

Study Sites (1)

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