Home Use Sensor Study

Diabetes Mellitus Clinical Trial

— HOUSE  

Official title:

Home Use Sensor (HOUSE) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02932514
• Other study ID #: CTP-0025
• Status: Active, not recruiting
• Phase: N/A
• First received: October 5, 2016
• Last updated: May 19, 2017
• Start date: October 2016

Study information

• Verified date: May 2017
• Source: Senseonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense Continuous Glucose Monitoring System (Eversense System) measurements when compared with a Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System usage, and assess the usability of the Eversense system in the hands of user at home setting. Changes in HbA1c from baseline will also be evaluated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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*

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Eversense (Senseonics) Continuous Glucose Monitoring System
Evaluate accuracy of Eversense CGM System to SMBG Meter. Compare performance between abdomen and arm insertion sites. Determine the usability of the Eversense System in a home-use setting for 180 days.

Locations

Country	Name	City	State
Sweden	Diabetic Center, Sahlgrenska University Hospital	Gothenburg
Sweden	Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Eversense CGM System for Arm and Abdomen Sensors compared to SMBG Meter as determined by Mean Absolute Relative Difference (MARD) calculations.		180 Days
Primary	Usability of the Eversense CGM System over 180 days will be evaluated through Study Questionnaires.		180 days