NCT01885546CompletedNot Applicable
Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AgaMatrix, Inc.
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- User's ability to obtain the enhanced meter feature
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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 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.
Arms & Interventions
Enhanced meter feature usability
Other
Home diabetes monitoring by patient using provided blood glucose monitoring system.
Intervention: AgaMatrix Blood Glucose Monitor (Device)
Outcomes
Primary Outcomes
User's ability to obtain the enhanced meter feature
Time Frame: 16 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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