Diabetes
Conditions
Brief summary
This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.
Interventions
DEVICEFingerstick
DEVICETAP20-C
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 with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested. 3. Subjects with a missing index or middle finger on either hand or a missing forearm 4. 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 various analytes in blood samples collected by both collection methods in a single 2 hour session. |
Countries
United States
Contacts
Primary ContactHoward Bernstein, MD, Phd
Outcome results
None listed