Home Use Sensor Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02932514
• Date of registration: 05/10/2016
• Prospective Registration: No
• Primary sponsor: Senseonics, Inc.
• Public title: Home Use Sensor Study HOUSE
• Scientific title: Home Use Sensor (HOUSE) Study
• Date of first enrolment: October 2016
• Target sample size: 17
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02932514
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Mona Landin-Olsson, M.D., Ph.D
• Affiliation: Skane University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult subjects, age =18 years

2. Clinically confirmed diagnosis of diabetes mellitus for =1 year and using insulin by
subcutaneous injection or insulin pump.

3. Subject has signed an informed consent form and is willing to comply with protocol
requirements

Exclusion Criteria:

1. Female subjects of childbearing capacity (defined as not surgically sterile or not
menopausal for = 1 year) who are lactating or pregnant, intending to become pregnant,
or not practicing birth control during the course of the study

2. A condition preventing or complicating the placement, operation or removal of the
sensor or wearing of transmitter, including upper extremity deformities or skin
condition

3. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient
ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic>160 mm
HG or diastolic >100 mm Hg at time of screening); current congestive heart failure;
history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with
asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may
participate if negative stress test within 1 year prior to screening and written
clearance from cardiologist documented.

4. History of hepatitis B, hepatitis C, or HIV

5. Currently receiving (or likely to need during the study period): immunosuppressant
therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin);
glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use
of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site
only); antibiotics for chronic infection (e.g. osteomyelitis, endocarditis)

6. A condition requiring or likely to require magnetic resonance imaging (MRI)

7. Known topical or local anesthetic allergy

8. Known allergy to glucocorticoids

9. Any condition that in the investigator's opinion would make the subject unable to
complete the study or would make it not in the subject's best interest to participate
in the study. Conditions include, but are not limited to, psychiatric conditions,
known current or recent alcohol abuse or drug abuse by subject history, a condition
that may increase the risk of induced hypoglycemia or risk related to repeated blood
testing. Investigator will supply rationale for exclusion

10. Participation in another clinical investigation (drug or device) within 2 weeks prior
to screening or intent to participate during the study period

11. The presence of any other active implanted device*



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Device: Eversense (Senseonics) Continuous Glucose Monitoring System

Primary Outcome(s)

Accuracy of Eversense CGM System for Arm and Abdomen Sensors compared to SMBG Meter as determined by Mean Absolute Relative Difference (MARD) calculations. [Time Frame: 180 Days]

Usability of the Eversense CGM System over 180 days will be evaluated through Study Questionnaires. [Time Frame: 180 days]

Secondary ID(s)

CTP-0025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors