Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
ELG, Diabetes
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.
Interventions
DEVICEELG
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.
Sponsors
XP Technology, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Clinical trials with a single arm
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event | Visit will last for up to 1-2 hours. This outcome will measure overnight fasting results. | 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 | 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. | 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. |
Countries
United States
Outcome results
None listed