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The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
Sponsor: XP Technology, LLC
Summary
This study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.
Official title: The ELG Analysis of Glucose a Correlational to Blood Glucose Assa
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-08-11
Completion Date
2025-11
Last Updated
2025-01-16
Healthy Volunteers
No
Interventions
ELG
The effectiveness of ELG to standardized blood test methods (fingerstick) and comparison to AlcNOW + (or equivalence) and of laboratory test results. Human subject requirements during ELG study will not challenge diabetics or non-diabetics glycemic event. For example, diabetes type 1, the subject will not have to adjust their insulin or glucose. For type 2 diabetes, the subject will not have to adjust their oral hypoglycemic agent or glucose, as well.
Locations (1)
Rouse Family Medical Clinic
Springdale, Arkansas, United States