The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Device: ELG

• Registration Number: NCT05055804
• Lead Sponsor: XP Technology, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-11
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELG Device Comparison to Whole Blood Testing	ELG	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 Measures

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

Trial Locations

Locations (1)

Rouse Family Medical Clinic; 🇺🇸 Springdale, Arkansas, United States