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PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor (PRECISE)

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ClinicalTrials.gov Identifier: NCT02154126
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
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 (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor
Study Start Date : May 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Accuracy assessment Device: Continuous Glucose Monitoring Device (Senseonics)



Primary Outcome Measures :
  1. Accuracy (mean absolute relative difference) compared to be reference device should be less than 20% [ Time Frame: 90 days ]
    To determine accuracy of the Senseonics CGM System measurements over successive periods of 30 days of Sensor use through 180 days post-insertion.



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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:

Subjects meeting all of the following inclusion criteria will be included in this study:

  1. Males and females ≥18 years of age
  2. Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy)
  3. Subject has signed an informed consent document and is willing to comply with protocol requirements

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will be excluded from this study:

  1. History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure
  2. Diabetic ketoacidosis in the past 6 months
  3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
  4. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure
  5. Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy including active retinopathy
  6. Hematocrit >50% or <30%
  7. Females lactating or pregnant or intending to become pregnant during the course of the investigation
  8. A condition requiring or likely to require magnetic resonance imaging

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): NCT02154126


Locations
Netherlands
Academic Medical Centre
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Senseonics, Inc.
Investigators
Principal Investigator: J.Hans de Vries, MD Academic Medical Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senseonics, Inc.
ClinicalTrials.gov Identifier: NCT02154126     History of Changes
Other Study ID Numbers: CTP-0004
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: May 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases