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

January 19, 2016 updated by: Senseonics, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Accuracy assessment
Device: Continuous Glucose Monitoring Device (Senseonics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senseonics, Inc.

Investigators

  • Principal Investigator: J.Hans de Vries, MD, Academic Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CTP-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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