NCT05055804

The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

The ELG Analysis of Glucose a Correlational to Blood Glucose Assa

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: XP Technology, LLC · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-08-11
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2021-09-24
• Last updated: 2025-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study