Accuracy Study for Enhanced Meter Feature

July 6, 2015 updated by: AgaMatrix, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • MassResearch, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type I or type II diabetes inclusive of the following populations:

    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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enhanced meter feature usability
Home diabetes monitoring by patient using provided blood glucose monitoring system.
Device: AgaMatrix Blood Glucose Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
User's ability to obtain the enhanced meter feature
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AgaMatrix, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AGAFPGM02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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