The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
XP Technology, LLC
Study ID
NCT05055804
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ELG — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 11, 2021
Status verified
Jan 2025
Primary completion
Oct 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ELG Device Comparison to Whole Blood Testing
    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.

Primary Outcome Measure

Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event [ Time Frame: Visit will last for up to 1-2 hours. This outcome will measure overnight fasting results. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rouse Family Medical ClinicSpringdaleArkansas72764-

Find similar trials in Springdale, AR

By condition
Type 1 diabetesType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Rouse Family Medical Clinic· Springdale, AR

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