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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Senseonics, Inc.

Study Description
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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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647905


Locations
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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
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Principal Investigator: Mark Christiansen, MD Diablo Clinical Research
More Information
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Responsible Party: Senseonics, Inc.
ClinicalTrials.gov Identifier: NCT02647905    
Other Study ID Numbers: CTP-0023
First Posted: January 6, 2016    Key Record Dates
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