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

Sponsors

Lead Sponsor: Senseonics, Inc.

Source Senseonics, Inc.
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.

Overall Status Completed
Start Date January 2016
Completion Date July 2016
Primary Completion Date July 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
CGM Relative Difference to Laboratory Reference Reported as MARD 90 days
Enrollment 90
Condition
Intervention

Intervention Type: Device

Intervention Name: Continuous Glucose Monitoring System

Description: Accuracy and safety assessment of a continuous glucose monitoring device

Arm Group Label: Accuracy assessment, CGMS

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mark Christiansen, MD Principal Investigator Diablo Clinical Research
Location
Facility:
John Muir Physician Network Clinical Research Center | Concord, California, 94520, United States
AMCR Institute | Escondido, California, 92025, United States
Diablo Clinical Research | Walnut Creek, California, 94598, United States
Atlanta Diabetes Care | Atlanta, Georgia, 30318, United States
Mount Sinai Diabetes Center | New York, New York, 10029, United States
Worldwide Clinical Trials | San Antonio, Texas, 78217, United States
Clinical Trials of Texas | San Antonio, Texas, 78229, United States
UVA Diabetes and Endocrine Clinic | Charlottesville, Virginia, 22903, United States
Rainier Clinical Research | Renton, Washington, 98057, United States
Location Countries

United States

Verification Date

May 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Accuracy assessment, CGMS

Type: Experimental

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

Acronym PRECISEII
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov