The ELG Analysis of Glucose a Correlational to Blood Glucose Assay

XP Technology

Status: Invitation-only

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Device: ELG

Study type: Interventional

Funder types: Other

Identifiers

NCT05055804

Q151642/S001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ELG Device Comparison to Whole Blood Testing

Experimental group

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.

Treatment:

Device: ELG