Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

April 24, 2023 updated by: Senseonics, Inc.

Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rocky Mountain Diabetes Center, LLC. (RMDC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Liljenquist
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Trials of Texas, LLC. (CTT)
        • Contact:
          • Shelbie Martin
          • Phone Number: 161 210-949-0122
        • Contact:
        • Principal Investigator:
          • Douglas S Denham, DO
    • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects meeting all of the following inclusion criteria will be included in this study:

  1. Subjects ≥14 years of age
  2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 years and older
  3. Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old
  4. Subject has signed an informed consent or assent form and parent/guardian has signed an informed consent, as applicable, and subject is willing to comply with protocol requirements.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:

  1. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure.
  2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months.
  3. Subjects with gastroparesis.
  4. Female subjects of childbearing capacity (defined as of child bearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
  5. A condition preventing or complicating the placement, operation, or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition.
  6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
  7. Hematocrit <38% or >60% at screening
  8. History of hepatitis B, hepatitis C, or HIV
  9. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study.
  10. History of adrenal insufficiency
  11. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only; antibiotic for chronic infection (e.g., osteomyelitis, endocarditis)
  12. For subjects inserted with the ROME CGM System: A condition requiring or likely to require magnetic resonance imaging (MRI)
  13. Known topical or local anesthetic allergy
  14. Known allergy to glucocorticoids
  15. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
  16. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
  17. The presence of any other active implanted device (as defined further in protocol)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous Glucose Monitoring Device
Eversense 524 CGM System and ROME CGM System.
Device: Continuous Glucose Monitoring System
Eversense 524 CGM System and ROME CGM System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.
Time Frame: 365 days
The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 365 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively.
365 days
Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.
Time Frame: 365 days
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events
365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senseonics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Anticipated)

March 30, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-0041

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Continuous Glucose Monitoring System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe