Evaluation of the Accuracy of an Implanted Glucose Sensor

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Accuracy assessment, CGMS	Continuous Glucose Monitoring System	To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days

Primary Outcome Measures

Name	Time	Method
CGM Relative Difference to Laboratory Reference Reported as MARD	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.

Secondary Outcome Measures

Name	Time	Method

Locations (9): Atlanta Diabetes Care
🇺🇸
Atlanta, Georgia, United States
Worldwide Clinical Trials
🇺🇸
San Antonio, Texas, United States
Rainier Clinical Research
🇺🇸
Renton, Washington, United States
Mount Sinai Diabetes Center
🇺🇸
New York, New York, United States
UVA Diabetes and Endocrine Clinic
🇺🇸
Charlottesville, Virginia, United States
Diablo Clinical Research
🇺🇸
Walnut Creek, California, United States
John Muir Physician Network Clinical Research Center
🇺🇸
Concord, California, United States
AMCR Institute
🇺🇸
Escondido, California, United States
Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States