Back to resultsThe ELG Analysis of Glucose a Correlational to Blood Glucose Assay
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ELG
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring ELG, Diabetes
Eligibility Criteria
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
Sites / Locations
- Rouse Family Medical Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ELG Device Comparison to Whole Blood Testing
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05055804
First Posted
September 1, 2021
Last Updated
September 14, 2021
Sponsor
XP Technology, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05055804
Brief Title
The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
Official Title
The ELG Analysis of Glucose a Correlational to Blood Glucose Assa
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
August 11, 2022 (Anticipated)
Study Completion Date
August 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XP Technology, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
ELG, Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trials with a single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ELG Device Comparison to Whole Blood Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ELG
Other Intervention Name(s)
ELG, Easy Light Glycometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event
Description
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.
Title
Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Non-Fasting Event
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Joe P Rouse, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Peter P Xaysanasy, DPM
Organizational Affiliation
XP Technology, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Rouse Family Medical Clinic
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
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