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Continuous Glucose Monitoring System
Continuous Glucose Monitoring for Diabetes
N/A
Waitlist Available
Research Sponsored by Senseonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
Subjects age ≥12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
Study Summary
This trial is testing how well a new, modified sensor works compared to the current sensor, and whether it is safe to use.
Who is the study for?
This trial is for individuals aged 12 or older with a confirmed diagnosis of diabetes for at least one year. Participants must be willing to follow the study's procedures and have signed an informed consent form. Pregnant women, those not using birth control, or with certain heart conditions, uncontrolled hypertension, skin conditions affecting sensor placement, severe allergies to local anesthetics or glucocorticoids are excluded.Check my eligibility
What is being tested?
The trial is testing modified Sensor designs in the Senseonics Continuous Glucose Monitoring System for up to 180 days. It aims to assess how long the system can last effectively and safely both in clinical settings and during participants' regular home use.See study design
What are the potential side effects?
Potential side effects may include skin irritation where the sensor is placed, allergic reactions if sensitive to materials used in sensors or transmitters, and possible inaccuracies leading to mismanagement of glucose levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with diabetes for at least a year.
Select...
I am 12 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CGM Relative Difference to Laboratory Reference reported as MARD
Trial Design
1Treatment groups
Experimental Treatment
Group I: ArmsExperimental Treatment1 Intervention
Evaluation of the effectiveness of modified Sensor designs on the longevity (up to 180 days) of the Senseonics Continuous Glucose Monitoring (CGM) System. The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.
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
1,968 Total Patients Enrolled
1 Trials studying Diabetes
925 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with diabetes for at least a year.I am 12 years old or older.I am currently on or might need immunosuppressants, chemotherapy, blood thinners, steroids, or antibiotics for a chronic infection during the study.I am not pregnant, breastfeeding, planning to become pregnant, or avoiding birth control during the study.I have heart issues like uncontrolled blood pressure or recent heart attacks.I have a history of hepatitis B, C, or HIV.I have a condition that makes it hard to use or wear medical devices on my body.
Research Study Groups:
This trial has the following groups:- Group 1: Arms
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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently recruiting participants for this project?
"As indicated on clinicaltrials.gov, this medical experiment is no longer looking for patients to partake in the study - it was first posted on October 1st 2016 and most recently updated May 19th 2017. Fortunately, there are 1173 alternative trials currently recruiting participants at present."
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