Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII)

Senseonics

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02647905

CTP-0023

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Accuracy assessment, CGMS

Experimental group

Description:

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

Treatment:

Device: Continuous Glucose Monitoring System