A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System in Canada

NCT ID: NCT02933164

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31

Brief Summary

The purpose of this clinical investigation is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arms

Evaluation of the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring System

Intervention Type: DEVICE

Effectiveness and safety of a Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System

Effectiveness and safety of a Continuous Glucose Monitoring System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects age ≥12 years

2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year

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 in the past 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); antibiotic 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 (as defined further in protocol)

12. The presence of any other CGM sensor or transmitter located in upper arm (other location is acceptable)

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senseonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LMC Clinical Research Inc.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CTP-0024

Identifier Type: -

Identifier Source: org_study_id