N/A N=115 Basic Science

User Study for Enhanced Meter Feature

Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01889355 ↗

Enrolled (actual)

115

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Enhanced Meter Feature Usability — 50 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AgaMatrix Blood Glucose Monitor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AgaMatrix, Inc.
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Enhanced Meter Feature Usability	50	—

Summary

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.

Eligibility 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:

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

Exclusion criteria EC 1. Pregnant EC 2. Hct 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01889355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.