The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouse Family Medical Clinic

Springdale, Arkansas, 72764, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ELG, Easy Light Glycometer

Primary outcomes

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

Time frame: 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

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.

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.

Sponsors and collaborators

Lead sponsor

XP Technology, LLC

Other

Registry information

Official study title

The ELG Analysis of Glucose a Correlational to Blood Glucose Assa

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Sep 24, 2021
Registry last updated: Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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