Accuracy Study for Enhanced Meter Feature

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: AgaMatrix Blood Glucose Monitor

• Registration Number: NCT01885546
• Lead Sponsor: AgaMatrix, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-25
• Study Start: 2013-07
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced meter feature usability	AgaMatrix Blood Glucose Monitor	Home diabetes monitoring by patient using provided blood glucose monitoring system.

Primary Outcome Measures

Name	Time	Method
User's ability to obtain the enhanced meter feature	16 weeks

Trial Locations

Locations (1)

MassResearch, LLC; 🇺🇸 Waltham, Massachusetts, United States