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Continuous Glucose Monitoring System
Eversense CGM for Diabetes (NA-PAS Trial)
Verified Trial
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
Subject has diabetes
Subject is ≥18 years of age
Must not have
Subjects requiring intravenous mannitol or mannitol irrigation solutions
Timeline
Screening 1 day
Treatment 12 months
Follow Up 30 days
Awards & highlights
NA-PAS Trial Summary
This trial is designed to study how well the Eversense CGM system works compared to self-monitoring of blood sugar in managing diabetes. The study will last for 12 months and will include clinic visits and home use of the Eversense CGM system.
Who is the study for?
Adults with Type 1 or Type 2 diabetes who have never used a continuous glucose monitor (CGM) for more than one week in the last six months. Participants must own an internet-enabled smartphone and be able to follow study instructions. Critically ill patients, those on dialysis, pregnant or nursing women, and individuals with certain medical conditions are excluded.Check my eligibility
What is being tested?
The study is testing the Eversense CGM System's effectiveness compared to traditional blood glucose meter monitoring over a year. For the first six months, participants will use their usual blood glucose meters; for the next six months, they'll switch to using Eversense CGM non-adjunctively.See study design
What are the potential side effects?
Potential side effects may include skin irritation from sensor insertion for the Eversense CGM system and possible allergic reactions to dexamethasone used in sensor adhesive if there's known sensitivity.
NA-PAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have diabetes.
Select...
I am 18 years old or older.
Select...
You have a smartphone that can connect to the internet.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need mannitol IV or for irrigation.
NA-PAS Trial Timeline
Screening ~ 1 day4 visits
Treatment ~ 12 months4 visits
Follow Up ~ 30 days0 visits
Screening ~ 1 day
Treatment ~ 12 months
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
NA-PAS Trial Design
1Treatment groups
Experimental Treatment
Group I: Self monitoring of blood glucose, then CGM SystemExperimental Treatment2 Interventions
All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood glucose meter
2018
N/A
~180
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Senseonics, Inc.Lead Sponsor
9 Previous Clinical Trials
1,079 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am critically ill or currently in the hospital.I have diabetes.I have diabetes.I am currently receiving dialysis.I am not pregnant, planning to become pregnant, or nursing.I need mannitol IV or for irrigation.I have diabetes.I am 18 years old or older.You have a smartphone that can connect to the internet.I am allergic or cannot take dexamethasone.I am 18 years old or older.You own a smartphone that can connect to the internet.You are able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion.
Research Study Groups:
This trial has the following groups:- Group 1: Self monitoring of blood glucose, then CGM System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 30 Months after you stop receiving the treatment.
Diabetes Patient Testimony for trial: Trial Name: NCT04836546 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability to join this research endeavor?
"Indeed, the clinical trial is open to applicants. It has been available since April 13th 2021 and was last modified on November 10th 2022 according to information provided on clinicaltrials.gov."
Answered by AI
How many facilities are hosting this research endeavor?
"The trial is being conducted at Atlanta Diabetes Associates in Georgia, The Center for Diabetes and Endocrine Care in Florida, and Rocky Mountain Clinical Research in Maryland. Additionally, there are 11 other sites participating throughout the U.S."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Other
Maryland
Florida
How old are they?
18 - 65
What site did they apply to?
MedCare Research
Atlanta Diabetes Associates
Miami Lakes Clinical Trials INC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
1
0
Why did patients apply to this trial?
81 yr old. Interested in trying CGM monitor. Porque quisieran que encontraran la cura y bajar de peso.
PatientReceived 1 prior treatment
I have a monitoring system now and would love the opportunity to try another one ! Thank you for your consideration!
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How many in office visits are required ? How many office visits are there during the trial period. And is there any compensation for the trial?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Miami Lakes Clinical Trials INC: < 48 hours
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