Evaluation of the Eversense Continuous Glucose Monitoring System

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

This study is testing how well and safely the Eversense Continuous Glucose Monitoring System works for adults and teens with diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Senseonics, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Escondido, California and 3 other locations)
• Trial ID: NCT05131139 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the accuracy and safety of the Eversense 524 Continuous Glucose Monitoring (CGM) System and ROME CGM System with enhanced features in adults and adolescents with diabetes. Participants aged 14 years and older will be monitored to compare the CGM systems' performance against reference glucose measurements. The study aims to ensure that these systems provide reliable glucose readings while assessing their safety for users. The evaluation will include both adult and pediatric populations with Type 1 Diabetes Mellitus.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 years and older with a clinically confirmed diagnosis of diabetes mellitus.

Not a fit: Patients with a history of severe hypoglycemia or diabetic ketoacidosis in the past six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved glucose monitoring for patients with diabetes, enhancing their ability to manage their condition effectively.

How similar studies have performed: Previous studies on continuous glucose monitoring systems have shown promising results, indicating that this approach has potential for success.

Eligibility criteria

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)

Where this trial is running

Escondido, California and 3 other locations

• AMCR Institute Inc. — Escondido, California, United States (Recruiting)
• Rocky Mountain Diabetes Center, LLC. (RMDC) — Idaho Falls, Idaho, United States (Recruiting)
• Clinical Trials of Texas, LLC. (CTT) — San Antonio, Texas, United States (Recruiting)
• Rainier Clinical Research Center — Renton, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Maggie Lewis

Conditions Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2