DiabetesNCT02045758
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick
A study testing Fingerstick and TAP20-C in people with Diabetes, run by Seventh Sense Biosystems at 1 site in United States.
Trial summary
This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Fingerstick and TAP20-C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subject Group
- Male and female volunteers 18 years of age or older.
- Voluntary written consent to participate in this study. Diabetic Subject Group
- <!-- -->
- Male and female volunteers 18 years of age or older.
- Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.
- Voluntary written consent to participate in this study.
Who cannot join
- Subjects who are pregnant or nursing mothers by self-report.
- Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
- Subjects with a missing index or middle finger on either hand or a missing forearm
- Subjects who have known allergies to titanium.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seventh Sense Biosystems
Cambridge, Massachusetts, 02141
About this study
This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.
- Conditions
- Diabetes
- Being tested
- Fingerstick, TAP20-C
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingerstickDevice
TAP20-CDevice
| Study group | Role | What they receive |
|---|---|---|
| TAP20-C | Experimental | TAP20-C Receives: Device: TAP20-C |
| Fingerstick | Active comparator | Fingerstick Receives: Device: Fingerstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Inferiority of Analyte Levels
The study will compare the concentrations of various analytes in blood samples collected by both collection methods in a single 2 hour session.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seventh Sense Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045758
- Sponsor's protocol ID
- 14-P002
- Status last verified
- Sep 2014
- First submitted
- 22 Jan 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick
- ClinicalTrials.gov ID
- NCT02045758
- Acronym / sponsor ID
- 14-P002
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seventh Sense BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP20-C | Experimental | Device: TAP20-CTAP20-C |
| Fingerstick | Active comparator | Device: FingerstickFingerstick |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy Subject Group
- <!-- -->
Key exclusion criteria (4 listed)
- Subjects who are pregnant or nursing mothers by self-report.
- Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
- Subjects with a missing index or middle finger on either hand or a missing forearm
- Subjects who have known allergies to titanium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingerstick | Device | Fingerstick |
| TAP20-C | Device | TAP20-C |
Primary outcome
Non-Inferiority of Analyte Levels
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
Related trials for Diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fingerstick and TAP20-C in people with Diabetes, run by Seventh Sense Biosystems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howard Bernstein, MD, Phd (617-547-7246, hbernstein@7sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Inferiority of Analyte Levels (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.