XP Technology, LLC
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.
Inclusion Criteria: * Have been diagnosed with type 1 or 2 diabetes * Be 25 - 65 years of age * Male or female * Various ethnicities are desired * Must be available for 2 visits within a 2-4 week period and willing to spend up to 1-2 hours/visit * Must have daytime availability for visits * Able to have 1 venous blood draw \& up to 4 fingersticks for complete blood testing at each visit * Must be willing and able to fast (for at least 6 hours) prior to first visit Exclusion Criteria: * Taking drugs of abuse (illegal and/or prescription) * Have been in another research study in the last 30 d…
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.
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