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Evaluation of the Accuracy of an Implanted Glucose Sensor | Clinical Trials | Clareo Health

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Evaluation of the Accuracy of an Implanted Glucose Sensor

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

NCT02647905•Senseonics, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult subjects, age ≥18 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. History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
•2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
•3. 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.
•4. A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
•5. 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.
•6. Hematocrit \<30% or \>55%
•7. History of hepatitis B, hepatitis C, or HIV
•8. 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.

Locations (9)

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

Key Dates

Start Date

January 1, 2016

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

June 6, 2018

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring System

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Accuracy of an Implanted Glucose Sensor

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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