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New treatment option for Diabetes
Official title ROME GS System Study
ClinicalTrials.gov ID: NCT07518004
What this study is testing
- What it's testing
- The purpose of this clinical investigation is to demonstrate that the proposed physical changes to the ROME GS Sensor do not have any adverse impact on safety and performance when compared to the Eversense 365 Sensor.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people meeting all of the following will be included in this study:
- people ≥18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements
You likely can't join if
- people meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of...
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- people with gastroparesis
- Female people of childbearing capacity (defined as of childbearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are...
- A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity...
See the full eligibility criteria
- people meeting all of the following will be included in this study:
- people ≥18 years of age
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements
- people meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- people with gastroparesis
- Female people of childbearing capacity (defined as of childbearing 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...
- A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic\>160 mm HG or diastolic \>100 mm Hg at time of...
- Hematocrit \ 60% at screening
- History of hepatitis B, hepatitis C, or HIV
- Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
- History of adrenal insufficiency
- Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only...
- A condition requiring or likely to require magnetic resonance imaging (MRI)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids
- 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...
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during study period
- The presence of another active implanted device\ \ An example of an active implanted device includes but is not limited to an implantable defibrillator. Passive implantable devices are allowed. An example of a passive...
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Walnut Creek, California, United States
- San Antonio, Texas, United States
- Renton, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Escondido, California, United States; Walnut Creek, California, United States; San Antonio, Texas, United States; Renton, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.