The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

The ELG Analysis of Glucose a Correlational to Blood Glucose Assa

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: ELG

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72764
      • Rouse Family Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; Other Names: ELG, Easy Light Glycometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: XP Technology, LLC
• Investigators: Principal Investigator: Dr. Joe P Rouse, MD; Study Director: Dr. Peter P Xaysanasy, DPM, XP Technology, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Anticipated): August 11, 2022
• Study Completion (Anticipated): August 11, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; ELG
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Q151642/S001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes