The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

NCT ID: NCT05055804

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2025-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ELG

Intervention Type: 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.

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.

Intervention Type: DEVICE

Other Intervention Names

ELG, Easy Light Glycometer

Eligibility Criteria

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 days
• Have had a blood transfusion or severe blood loss in the last 14 days
• Have Sickle Cell Anemia

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XP Technology, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Joe P Rouse, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Peter P Xaysanasy, DPM

Role: STUDY_DIRECTOR

XP Technology, LLC

Locations

Rouse Family Medical Clinic

Springdale, Arkansas, United States

Countries

United States

Other Identifiers

Q151642/S001

Identifier Type: -

Identifier Source: org_study_id