ClinicalTrials.Veeva

Menu
The trial is taking place at:
M

Metro Detroit Endocrinology Center | Dearborn, MI

Veeva-enabled site

Post Approval Study of the Eversense® Continuous Glucose Monitoring (PAS)

S

Senseonics

Status

Active, not recruiting

Conditions

Diabetes Mellitus, Type 1
Diabetes Mellitus
Diabetes Mellitus, Type 2

Treatments

Device: Eversense® CGM system

Study type

Interventional

Funder types

Industry

Identifiers

NCT03908125
CTP-0034

Details and patient eligibility

About

A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System

Full description

The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days.

The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PASstudy will provide safety and effectiveness data up to 27 months of repeated use.

Enrollment

273 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subject has diabetes
  2. Subject is greater than 18 years of age

Exclusion criteria

  1. Subject is critically ill or hospitalized
  2. Subject has a known contraindication to dexamethasone or dexamethasone acetate
  3. Subjects requiring intravenous mannitol or mannitol irrigation solutions
  4. Female subjects who are pregnant, planning on becoming pregnant or nursing
  5. Subjects on hybrid closed loop systems or closed loop systems
  6. Subjects on other CGM systems

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

273 participants in 1 patient group

Continuous Glucose Monitoring Device
Other group
Treatment:
Device: Eversense® CGM system

Trial contacts and locations

17

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems