Eversense Gemini system with new flash glucose feature — testing accuracy and safety

Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature

This will test whether the Eversense Gemini wearable glucose monitor with a new flash feature gives accurate and safe glucose readings for adults with type 1 or type 2 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Senseonics, Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Escondido, California)
• Trial ID: NCT07386340 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter evaluation comparing glucose readings from the Eversense Gemini system with its new flash glucose measurement feature against reference glucose measurements and the existing Eversense 365 CGM system. Adult participants with a clinical diagnosis of diabetes for at least one year will wear the device and undergo scheduled reference glucose checks to measure accuracy. The study will also collect safety data and record any device-related adverse events. Participants with recent severe hypoglycemia, recent diabetic ketoacidosis, gastroparesis, or who are pregnant or lactating are excluded.

Who should consider this trial

Good fit: Adults aged 18 or older with type 1 or type 2 diabetes diagnosed at least one year earlier who can give informed consent and follow study procedures are ideal candidates.

Not a fit: People with recent severe hypoglycemia or diabetic ketoacidosis, gastroparesis, pregnant or lactating women, or those under 18 are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the Gemini system could provide adults with diabetes more accurate and convenient glucose readings that help with day-to-day glucose management.

How similar studies have performed: Prior studies of implanted Eversense CGM systems, including the Eversense 365, have shown acceptable accuracy and safety, though the specific flash measurement enhancements in Gemini are newer.

Eligibility criteria

Inclusion Criteria:

Subjects meeting all of the following inclusion criteria will be included in this study:

1. Subjects ≥18 years of age
2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
3. Subject has signed an informed consent form (ICF) and 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 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 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 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. 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 the protocol)

Where this trial is running

Escondido, California

• Headlands Research - AMCR Institute — Escondido, California, United States (RECRUITING)

Study contacts

• Study coordinator: Maggie Lewis

Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2