Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how accurate and safe the Eversense Gemini blood sugar monitoring system is with its new flash measurement feature. It compares Gemini readings with reference blood sugar tests and the Eversense 365 system. It is for adults who have had diabetes for at least 1 year.
A prospective, multicenter evaluation of performance and safety of the Eversense Gemini System with flash glucose measurement feature. The purpose of this clinical investigation is to evaluate the accuracy of the Gemini System with new technological flash glucose monitoring (FGM) feature enhancements compared to reference glucose measurements and the Eversense 365 CGM System. The investigation will also evaluate safety of the Gemini System usage.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older.
- A doctor has confirmed that you have had diabetes for at least 1 year.
- You have signed a consent form and are willing to follow the study rules.
Who can't join
- In the past 6 months, you had low blood sugar that caused a seizure or made you pass out, or diabetic ketoacidosis (dangerous acid buildup) that needed emergency or hospital care. You have gastroparesis (slow stomach emptying) or a history of adrenal glands not making enough hormones.
- You can become pregnant and are pregnant, breastfeeding, planning pregnancy, or not using birth control during the study.
- You have a condition that makes placing, using, or removing the sensor or wearing its transmitter difficult; may need an MRI scan; or have another active implanted device.
- You have heart artery disease with symptoms, unstable chest pain, heart failure, certain irregular heartbeats, or blood pressure above 160/100. You had a heart attack, stroke, or mini-stroke in the past 6 months. Heart artery disease without symptoms requires a negative stress test within 1 year and written heart doctor approval.
- Your hematocrit (the share of blood made up of red blood cells) is below 38% or above 60%. You have a history of hepatitis B, hepatitis C, or HIV, or are being treated for seizures without written approval from a nerve specialist.
- You take or may need medicines that weaken the immune system, chemotherapy, blood clot prevention medicines other than aspirin, steroid creams at the sensor site, or antibiotics for a long-term infection. You are allergic to local numbing medicines or glucocorticoids (steroid medicines).
- The study doctor believes a condition could make the study unsafe, keep you from finishing, or make joining not in your best interest. This may include mental health conditions, current or recent alcohol or drug abuse, or added risks from low blood sugar or repeated blood tests.
- You joined another drug or device study within 2 weeks before screening, or plan to join one during this study.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
CA
- Headlands Research - AMCR Institute · Escondido, CA 92025Jenine Yager Stone, PhD, MSN, FNP-C · Study contact · 760-466-1520 · jenine.yagerstone@headlandsresearchamcr.comMore trials in Escondido