Accuracy Study for Enhanced Meter Feature

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885546
• Other study ID #: AGAFPGM02
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: July 6, 2015
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: AgaMatrix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• AgaMatrix Blood Glucose Monitor

Locations

Country	Name	City	State
United States	MassResearch, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AgaMatrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User's ability to obtain the enhanced meter feature		16 weeks	No