Post Approval Study of the Eversense® Continuous Glucose Monitoring

Senseonics, Inc.273 enrolled

Overview

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

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 PAS study will provide safety and effectiveness data up to 27 months of repeated use.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

273

Conditions

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

Interventions

Eversense® CGM SystemDEVICE

Continuous Glucose monitoring device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center

Newport Beach, California, United States

Denver Endocrinology, Diabetes & Thyroid Center

Englewood, Colorado, United States

Outcomes

Primary Outcomes

The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.

The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%.

Time frame: up to 27 months

The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.

The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.

Time frame: Baseline and Month 12

Secondary Outcomes

The Additional Effectiveness Endpoint of Average Hours of Use Per Day

Time frame: up to 27 months

The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline

Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24

Patient Satisfaction With CGM System Use (CGM-SAT Scale)

CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.

Time frame: up to 27 months

Patient Reported Diabetes Distress Scale (DDS)

The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.

Time frame: Screening, Day 180, Day 360, and Day 720

Success Rate of Insertion Procedures: Overall and by HCP Experience

Data from ClinicalTrials.gov

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