NCT02154126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

May 23, 2014

Last Update Submit

January 19, 2016

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Accuracy (mean absolute relative difference) compared to be reference device should be less than 20%

    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

Study Arms (1)

Accuracy assessment

OTHER
Device: Continuous Glucose Monitoring Device (Senseonics)

Interventions

Continuous Glucose Monitoring Device (Senseonics)DEVICE
Accuracy assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥18 years of age
  • 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)
  • Subject has signed an informed consent document and is willing to comply with protocol requirements

You may not qualify if:

  • History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure
  • Diabetic ketoacidosis in the past 6 months
  • Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
  • 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
  • Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy including active retinopathy
  • Hematocrit \>50% or \<30%
  • Females lactating or pregnant or intending to become pregnant during the course of the investigation
  • A condition requiring or likely to require magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Centre

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (1)

  • Kropff J, Choudhary P, Neupane S, Barnard K, Bain SC, Kapitza C, Forst T, Link M, Dehennis A, DeVries JH. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care. 2017 Jan;40(1):63-68. doi: 10.2337/dc16-1525. Epub 2016 Nov 4.

    PMID: 27815290DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • J.Hans de Vries, MD

    Academic Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 3, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 21, 2016

Record last verified: 2015-05

Locations

NL(1)