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

NCT07386340 | Recruiting DMC FDA Device

• 1 other identifier: CTP-0050
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• System agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL.

  Effectiveness Objective: To determine accuracy of the Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System. The effectiveness measure will be system agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively and compared to the Eversense 365 CGM System.

  365 days

• Number of device-related or sensor insertion/removal procedure-related serious adverse events

  Safety Objective: To demonstrate safety of the Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System. Incidence of device-related or sensor insertion/removal procedure-related serious adverse events in clinic and during home use from sensor insertion through removal and follow-up.

  365 days

Study Arms (1)

Continuous Glucose Monitoring Device

EXPERIMENTAL

Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System

Continuous Glucose Monitoring Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥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 may not qualify if:

• History of 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.
• Subjects with gastroparesis.
• 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.
• 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 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.
• Hematocrit \<38% or \>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; antibiotic for chronic infection (e.g., osteomyelitis, endocarditis)
• A condition requiring or likely to require magnetic resonance imaging (MRI)
• Known topical or local anesthetic allergy
• Known allergy to glucocorticoids
• Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period

Sponsors & Collaborators

• Senseonics, Inc.: lead

Study Sites (1)

Headlands Research - AMCR Institute

Escondido, California, 92025, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Maggie Lewis

CONTACT

667-218-3309; maggie.lewis@senseonics.com

Susan Huynh

CONTACT

301-407-2923; susan.huynh@senseonics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)