The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

NCT05055804 | Enrolling By Invitation FDA Device

• 1 other identifier: Q151642/S001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

ELG; Diabetes

Outcome Measures

Primary Outcomes (2)

• Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event

  Measuring precision and accuracy of ELG (glucose/A1C %) without blood samples, by performance evaluation to 3 different standard OTC fingerstick, A1C Now (or equivalent OTC brand) and NGSP-certified lab, using whole blood comparative tests with use of venous blood draw/fingersticks and NGSP-certified lab, and assess confidence limits to Bland-Altman plot, after overnight fasting for a minimum of 6 hours.

  Visit will last for up to 1-2 hours. This outcome will measure overnight fasting results.

• Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Non-Fasting Event

  Measuring precision and accuracy of ELG (glucose/A1C %) without blood samples, by performance evaluation to 3 different standard OTC fingerstick, A1C Now (or equivalent OTC brand) and NGSP-certified lab, using whole blood comparative tests with use of venous blood draw/fingersticks and NGSP-certified lab, and assess confidence limits to Bland-Altman plot, during non-fasting.

  This visit will be measured within a 4 week time frame, following the 1st visit. This visit will last for up to 1-2 hours. This outcome will measure non-fasting results.

Study Arms (1)

ELG Device Comparison to Whole Blood Testing

EXPERIMENTAL

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.

Device: ELG

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.

Also known as: ELG, Easy Light Glycometer

ELG Device Comparison to Whole Blood Testing

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• XP Technology, LLC: lead

Study Sites (1)

Rouse Family Medical Clinic

Springdale, Arkansas, 72764, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr. Joe P Rouse, MD

  PRINCIPAL INVESTIGATOR

• Dr. Peter P Xaysanasy, DPM

  XP Technology, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trials with a single arm

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 24, 2021
• Study Start: August 11, 2021
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)