User Study for Enhanced Meter Feature
User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
1 other identifier
interventional
121
1 country
1
Brief Summary
This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control. This study will evaluate a user's ability to use 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 Jan 2014
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 28, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
August 6, 2018
CompletedAugust 6, 2018
March 1, 2014
1 month
June 21, 2013
July 10, 2018
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Enhanced Meter Feature Usability
The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
4 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:
- IC 1. Age of subject is 18 years or older
- IC 2. Type I or type II diabetes inclusive of the following populations:
- Mixed insulin therapies
- Basal insulin therapies
- Bolus insulin therapies
- CSII therapies
- MDI therapies
- Non-insulin diabetic treatments (oral and injectable)
- Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently
You may not qualify if:
- EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
- EC 9. Previous experience using the MyStar Extra BGMS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AgaMatrix, Inc.lead
Study Sites (1)
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Clinical Research Technician
- Organization
- AgaMatrix, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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 28, 2013
Study Start
January 1, 2014
Primary Completion
February 1, 2014
Study Completion
March 1, 2014
Last Updated
August 6, 2018
Results First Posted
August 6, 2018
Record last verified: 2014-03