A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II

Senseonics, Inc.9 sites in 1 country90 target enrollmentJanuary 2016

ConditionsDiabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Senseonics, Inc.
Enrollment: 90
Locations: 9
Primary Endpoint: CGM Relative Difference to Laboratory Reference Reported as MARD
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

July 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Senseonics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult subjects, age ≥18 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

Exclusion Criteria

•History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
•History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
•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.
•Hematocrit \<30% or \>55%
•History of hepatitis B, hepatitis C, or HIV
•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.

Outcomes

Primary Outcomes

CGM Relative Difference to Laboratory Reference Reported as MARD

Time Frame: 90 days

Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.