What this study is
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.
What's being tested
- ELG
Intervention · 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.
Study details
- Official title
- The ELG Analysis of Glucose a Correlational to Blood Glucose Assa
- Sponsor
- XP Technology, LLC
- Conditions
- Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2
- Enrolling
- 100 people
- Starts
- 2021-08-11
- Est. completion
- 2025-11
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRouse Family Medical Clinic
Springdale, Arkansas, United States
Study team
Sponsor
XP Technology, LLC
Study ID Q151642/S001
Principal investigator
Dr. Joe P Rouse, MD
Study director
Dr. Peter P Xaysanasy, DPM
XP Technology, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.