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

• ClinicalTrials.gov Identifier: NCT02647905
• Recruitment Status: Completed
• First Posted: January 6, 2016
• Results First Posted: June 6, 2018
• Last Update Posted: June 6, 2018
• Sponsor: Senseonics, Inc.
• Information provided by (Responsible Party): Senseonics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus	Device: Continuous Glucose Monitoring System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
• Study Start Date: January 2016
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Accuracy assessment, CGMS; 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	Device: Continuous Glucose Monitoring System; Accuracy and safety assessment of a continuous glucose monitoring device

Outcome Measures

Primary Outcome Measures :

1. CGM Relative Difference to Laboratory Reference Reported as MARD [ Time Frame: 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.

Other Outcome Measures:

1. CGM System Agreement With Reference Control [ Time Frame: 90 days ]
   The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

John Muir Physician Network Clinical Research Center

Concord, California, United States, 94520

AMCR Institute

Escondido, California, United States, 92025

Diablo Clinical Research

Walnut Creek, California, United States, 94598

United States, Georgia

Atlanta Diabetes Care

Atlanta, Georgia, United States, 30318

United States, New York

Mount Sinai Diabetes Center

New York, New York, United States, 10029

United States, Texas

Worldwide Clinical Trials

San Antonio, Texas, United States, 78217

Clinical Trials of Texas

San Antonio, Texas, United States, 78229

United States, Virginia

UVA Diabetes and Endocrine Clinic

Charlottesville, Virginia, United States, 22903

United States, Washington

Rainier Clinical Research

Renton, Washington, United States, 98057

Sponsors and Collaborators

Senseonics, Inc.

Investigators

• Principal Investigator: Mark Christiansen, MD; Diablo Clinical Research

More Information

• Responsible Party: Senseonics, Inc.
• ClinicalTrials.gov Identifier: NCT02647905
• Other Study ID Numbers: CTP-0023
• First Posted: January 6, 2016
• Results First Posted: June 6, 2018
• Last Update Posted: June 6, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Senseonics, Inc.:

type 1 diabetes; type 2 diabetes; CGM; implantable; accuracy; longevity