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NCT01889355 Clinical Trial

User Study for Enhanced Meter Feature

Diabetes Mellitus Clinical Trial

Official title:
User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01889355
Other study ID # AGAFPGM01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date March 2014

Study information
Verified date March 2014
Source AgaMatrix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

IC 1. Age of subject is 18 years or older

IC 2. Type I or type II diabetes inclusive of the following populations:

1. Mixed insulin therapies

2. Basal insulin therapies

3. Bolus insulin therapies

4. CSII therapies

5. MDI therapies

6. Non-insulin diabetic treatments (oral and injectable)

7. Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently

Exclusion criteria EC 1. Pregnant EC 2. Hct <20 or >60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• AgaMatrix Blood Glucose Monitor

Locations
Country Name City State
United States Atlanta Diabetes Associates Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
AgaMatrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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