The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

N/AEnrolling By InvitationNCT05055804

XP Technology, LLC100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

ELGDEVICE

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Rouse Family Medical Clinic

Springdale, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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