Accuracy Study for Enhanced Meter Feature
Accuracy Study for the Evaluation of Obtaining an Enhanced Meter Feature Using an AgaMatrix BGMS
1 other identifier
interventional
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Jul 2013
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 8, 2015
January 1, 2014
4 months
June 21, 2013
July 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
User's ability to obtain the enhanced meter feature
16 weeks
Study Arms (1)
Enhanced meter feature usability
OTHERHome diabetes monitoring by patient using provided blood glucose monitoring system.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AgaMatrix, Inc.lead
Study Sites (1)
MassResearch, LLC
Waltham, Massachusetts, 02453, United States
Related Publications (1)
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.
PMID: 26002835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2013
First Posted
June 25, 2013
Study Start
July 1, 2013
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
July 8, 2015
Record last verified: 2014-01