The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The ELG Analysis of Glucose a Correlational to Blood Glucose Assa

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05055804
• Other study ID #: Q151642/S001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: August 11, 2022

Study information

• Verified date: September 2021
• Source: XP Technology, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Device:
• ELG
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.

Locations

Country	Name	City	State
United States	Rouse Family Medical Clinic	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
XP Technology, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.