At a glance
ClinicalIndex Comparison Record- ✓Type 1 or type 2 diabetes
- ✓Age 18–75 years (not yet 76th birthday), with ~50% under age 55
- ✓Routine home blood glucose testing at least once per day
- ✓Able to speak, read, and understand English and study labeling
- ✕Pregnancy
- ✕Physical (dexterity), visual, or neurological impairments impairing device use
- ✕Disorders or infection in fingertip lancing areas
- ✕Acute or chronic skin infections
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Labeling Comprehension and Performance Evaluation of the Apollo Blood Glucose Monitoring System With Capillary Blood [Commercial Name is CONTOUR® USB]
In Brief
A clinical study evaluating Apollo Blood Glucose Monitoring System for Diabetes. Completed, enrolled 74 participants across 1 site.
Detailed Summary
The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
Study Details
Timeline
Interventions
Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.