Evaluation of the Accuracy of an Implanted Glucose Sensor

Completed · Not applicable

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02647905

Run by

Senseonics, Inc.

People needed

90

Starts

2016-01-01

Expected to finish

2016-07-01

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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