ELG Device for Diabetes

Recruiting in Palo Alto (17 mi)

Overseen ByDr. Joe P Rouse, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: XP Technology, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 25-65 with type 1 or type 2 diabetes. Participants must be available for two visits over 2-4 weeks, willing to fast for at least six hours before the first visit, and able to undergo a venous blood draw and up to four fingersticks per visit.

Inclusion Criteria

I have been diagnosed with diabetes.

I am between 25 and 65 years old.

Exclusion Criteria

I have sickle cell anemia.

I have not had a blood transfusion or severe blood loss in the last 14 days.

Participant Groups

The study tests the ELG medical device that monitors glucose levels in diabetic patients without needing blood samples. It compares this non-invasive method's accuracy against traditional blood testing methods.

1Treatment groups

Experimental Treatment

Group I: ELG Device Comparison to Whole Blood TestingExperimental Treatment1 Intervention

Participant will place thumb in the ELG device for scan. Scan generally takes between 1-2 minutes. ELG then displays a readout of both a glucose and A1C reading on the screen of the ELG device.