User Study for Enhanced Meter Feature

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.

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

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

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

Treatment and study plan

AgaMatrix Blood Glucose Monitor

Device

Primary outcomes

Enhanced Meter Feature Usability

Time frame: 4 weeks

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).

Sponsors and collaborators

Lead sponsor

AgaMatrix, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jun 28, 2013
Registry last updated: Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed