Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
133 participants
INTERVENTIONAL
2013-07-31
2013-12-31
Brief Summary
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This study will evaluate a user's ability to obtain the enhanced meter feature.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Enhanced meter feature usability
Home diabetes monitoring by patient using provided blood glucose monitoring system.
AgaMatrix Blood Glucose Monitor
Interventions
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AgaMatrix Blood Glucose Monitor
Eligibility Criteria
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Inclusion Criteria
1. Mixed insulin therapies
2. Basal insulin therapies
3. Continuous subcutaneous insulin infusion therapies
4. Multiple daily injection therapies
5. Non-insulin diabetic treatments (oral and injectable)
6. Life style (exercise and diet) diabetes management
7. New diagnosis of diabetes
* Non diabetics
* Able to speak and read English proficiently
* Subjects must be willing to:
1. once a month, perform a 7 point blood glucose profile over the course of one day
2. perform fasting blood glucose tests every day
3. complete baseline and follow-up questionnaires
4. consent to baseline HbA1c assays
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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AgaMatrix, Inc.
INDUSTRY
Responsible Party
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Locations
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MassResearch, LLC
Waltham, Massachusetts, United States
Countries
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References
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Sieber J, Flacke F, Dumais B, Peters CC, Mallery EB, Taylor L. Evaluation of a Methodology for Estimating HbA1c Value by a New Glucose Meter. J Diabetes Sci Technol. 2015 May 22;10(1):67-71. doi: 10.1177/1932296815587323.
Other Identifiers
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AGAFPGM02
Identifier Type: -
Identifier Source: org_study_id
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