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Completed

NCT Number: NCT01885546

Accuracy Study for Enhanced Meter Feature

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.

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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

MassResearch, LLC

Waltham, Massachusetts, 02453, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

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.

Treatment and study plan

AgaMatrix Blood Glucose Monitor

Device

Primary outcomes

  1. User's ability to obtain the enhanced meter feature

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

AgaMatrix, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2013
Registry last updated
Jul 8, 2015

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.

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