The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

Study Overview
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Brief Summary
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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.

Official Title
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The ELG Analysis of Glucose a Correlational to Blood Glucose Assa

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: ELG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Clinical trials with a single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELG Device Comparison to Whole Blood Testing<br>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<br>* 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.<br>* Other names: ELG, Easy Light Glycometer;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ELG, Diabetes