Diabetes, Anemia
Conditions
Brief summary
This study will compare blood collection from the forearm using an investigational device, TAP20-C to blood collection from the finger tip. The blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.
Interventions
DEVICETAP20-C
DEVICESAFE-T-FILL
Sponsors
Seventh Sense Biosystems
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Subject Group 1. Male and female volunteers 18 years of age or older. 2. Voluntary written consent to participate in this study. Diabetic Subject Group 1. Male and female volunteers 18 years of age or older. 2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report. 3. Voluntary written consent to participate in this study.
Exclusion criteria
1. Subjects who are pregnant or nursing mothers by self-report. 2. Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins. 3. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested. 4. Subjects with a missing index or middle finger on either hand or a missing forearm 5. Subjects who have known allergies to titanium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non Inferiority of Analyte Levels | Day 1 | The study will compare the concentrations of glucose, hemoglobin and hemoglobin A1c in blood samples collected with the two different blood collection methods in a single 2 1/2 hour session. |
Countries
United States
Outcome results
None listed