← Back to Search

Continuous Glucose Monitoring System

Continuous Glucose Monitoring for Diabetes

N/A
Recruiting
Research Sponsored by Senseonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects greater than or equal to18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights

Study Summary

This trial is testing the accuracy and safety of the Eversense 524 Continuous Glucose Monitoring System, which is designed to help people with diabetes manage their condition.

Who is the study for?
Adults and adolescents with diabetes (Type 1 or Type 2) can join this trial. Adults must have had diabetes for at least a year, while teens aged 14-17 need a confirmed diagnosis of Type 1 Diabetes for the same duration. Participants must consent to follow study rules. Those with certain health issues, drug abuse history, severe hypoglycemia, specific infections like hepatitis or HIV, allergies to anesthetics or glucocorticoids, recent heart problems, uncontrolled hypertension, or who are pregnant cannot join.Check my eligibility
What is being tested?
The Eversense CGM System is being tested for its accuracy and safety in monitoring blood sugar levels compared to standard glucose tests. This includes new features in the system designed to improve user experience. The study involves adults and some teenagers with diabetes and will compare readings from the device with traditional reference measurements.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the device attaches, possible allergic reactions if sensitive to materials used in the CGM system components; discomfort during insertion/removal of sensors; risk of inaccurate glucose readings leading to mismanagement of insulin doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.
Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Continuous Glucose Monitoring DeviceExperimental Treatment1 Intervention
Eversense 524 CGM System and ROME CGM System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitoring System
2016
N/A
~520

Find a Location

Who is running the clinical trial?

Senseonics, Inc.Lead Sponsor
9 Previous Clinical Trials
1,654 Total Patients Enrolled
1 Trials studying Diabetes
925 Patients Enrolled for Diabetes

Media Library

Eversense CGM System (Continuous Glucose Monitoring System) Clinical Trial Eligibility Overview. Trial Name: NCT05131139 — N/A
Diabetes Research Study Groups: Continuous Glucose Monitoring Device
Diabetes Clinical Trial 2023: Eversense CGM System Highlights & Side Effects. Trial Name: NCT05131139 — N/A
Eversense CGM System (Continuous Glucose Monitoring System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131139 — N/A
Diabetes Patient Testimony for trial: Trial Name: NCT05131139 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this clinical experiment?

"This clinical trial necessitates the recruitment of 120 patients that comply with specific requirements. Prospective participants can register at Clinical Trials of Texas, LLC or AMCR Institute Inc., both located in San Antonio and Escondido respectively."

Answered by AI

Is this investigation currently enrolling participants?

"Clinicaltrials.gov states that this clinical trial is recruiting participants, with its initial posting on October 20th 2021 and the most recent update being made on May 11th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Other
California
Texas
How old are they?
18 - 65
What site did they apply to?
Rainier Clinical Research Center
Clinical Trials of Texas, LLC. (CTT)
AMCR Institute Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+

Why did patients apply to this trial?

I want to see a cure in my T1D son's lifetime. I have been a user of the Abbott FreeStyle Libre systems for about three years.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. AMCR Institute Inc.: < 24 hours
  2. Rainier Clinical Research Center: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
2021. "Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05131139.
All > Type 1 Diabetes > Diabetes Type 2
~94 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top