User Study for Enhanced Meter Feature

AgaMatrix

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: AgaMatrix Blood Glucose Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01889355

AGAFPGM01

Details and patient eligibility

About

This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.

This study will evaluate a user's ability to use the enhanced meter feature.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

IC 1. Age of subject is 18 years or older

IC 2. Type I or type II diabetes inclusive of the following populations:

1. Mixed insulin therapies
2. Basal insulin therapies
3. Bolus insulin therapies
4. CSII therapies
5. MDI therapies
6. Non-insulin diabetic treatments (oral and injectable)
7. Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently

Exclusion criteria EC 1. Pregnant EC 2. Hct <20 or >60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.

EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

EC 9. Previous experience using the MyStar Extra BGMS

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 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