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

Tracking Information
First Submitted Date  ICMJE December 31, 2015
First Posted Date  ICMJE January 6, 2016
Results First Submitted Date  ICMJE April 2, 2018
Results First Posted Date  ICMJE June 6, 2018
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2018)
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%)
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of the Accuracy of an Implanted Glucose Sensor
Official Title  ICMJE A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Device: Continuous Glucose Monitoring System
Accuracy and safety assessment of a continuous glucose monitoring device
Study Arms  ICMJE 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
Intervention: Device: Continuous Glucose Monitoring System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02647905
Other Study ID Numbers  ICMJE CTP-0023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Senseonics, Inc.
Study Sponsor  ICMJE Senseonics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Christiansen, MD Diablo Clinical Research
PRS Account Senseonics, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP