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

NCT02933164 | Unknown

• 1 other identifier: CTP-0024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• CGM Relative Difference to Laboratory Reference reported as MARD

  Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.

  180 days

Study Arms (1)

Arms

EXPERIMENTAL

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.

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

Effectiveness and safety of a Continuous Glucose Monitoring System

Arms

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age ≥12 years
• Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
• Subject has signed an informed consent form and is willing to comply with protocol requirements

You may not qualify if:

• 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.
• A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
• 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.
• History of hepatitis B, hepatitis C, or HIV
• Currently receiving (or likely to need during the study period):
• A condition requiring or likely to require magnetic resonance imaging (MRI)
• Known topical or local anesthetic allergy
• Known allergy to glucocorticoids
• Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
• The presence of any other active implanted device (as defined further in protocol)
• The presence of any other CGM sensor or transmitter located in upper arm (other location is acceptable)

Sponsors & Collaborators

• Senseonics, Inc.: lead

Study Sites (1)

LMC Clinical Research Inc.

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

CA (1)