The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ELG.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The ELG Analysis of Glucose a Correlational to Blood Glucose Assa
Overview
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.
Interventions
- 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.
Primary outcome measures
- Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event [Time frame: 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 [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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Rouse Family Medical Clinic — Springdale
Identifiers
NCT: NCT05055804 · Q151642/S001