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

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)

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273 participants in 1 patient group

Continuous Glucose Monitoring Device

Other group

Treatment:

Device: Eversense® CGM system