Accuracy Study for Enhanced Meter Feature

A

AgaMatrix

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: AgaMatrix Blood Glucose Monitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885546
AGAFPGM02

Details and patient eligibility

About

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.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

133 participants in 1 patient group

Enhanced meter feature usability
Other group
Description:
Home diabetes monitoring by patient using provided blood glucose monitoring system.
Treatment:
Device: AgaMatrix Blood Glucose Monitor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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