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

A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System

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

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Eversense® CGM system

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Denver Endocrinology, Diabetes & Thyroid Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33312
      • The Center for Diabetes and Endocrine Care
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • MODEL Clinical Research
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Metro Detroit Endocrinology Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Diabetes and Endocrinology Specialists, Inc.
  • New York
    • Albany, New York, United States, 12206
      • Albany Medical College
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Health/PMG
  • Pennsylvania
    • Feasterville, Pennsylvania, United States, 19053
      • Diabetes & Endocrinology Consultants of Pennsylvania, LLC
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes & Endocrinology
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology
    • Cypress, Texas, United States, 77433
      • Clinical Research Solution, LLC
    • Houston, Texas, United States, 77095
      • Javara, Inc.
    • San Antonio, Texas, United States, 78229
      • Diabetes and Glandular Disease Clinic
    • Shavano Park, Texas, United States, 78231
      • Consano Clinical Research, Diabetes and Metabolism Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Glucose Monitoring Device	Device: Eversense® CGM system; Continuous Glucose monitoring device that lasts up to 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of procedure-related adverse events	The primary safety endpoint is the Incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity	12 months
Time in Range	The primary effectiveness endpoint is Time in Range, which is defined as glucose values between 70mg/dL and 180 mg/dL, at 12 months post first sensor insertion compared to first month post first sensor insertion	12 months

Collaborators and Investigators

• Sponsor: Senseonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Estimated): February 3, 2024
• Study Completion (Estimated): August 3, 2024

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CTP-0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes