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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Continuous Glucose Monitoring System

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maggie Lewis; Phone Number: 667-218-3309; Email: maggie.lewis@senseonics.com
• Study Contact Backup: Name: Susan Huynh; Phone Number: 301-407-2923; Email: susan.huynh@senseonics.com

Study Locations

• United States
  • California
    • Escondido, California, United States, 92025
      • Recruiting
      • Headlands Research - AMCR Institute
      • Contact: Jenine Yager Stone, PhD, MSN, FNP-C; Phone Number: 760-466-1520; Email: jenine.yagerstone@headlandsresearchamcr.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring Device; Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System	Device: Continuous Glucose Monitoring System; Eversense 365 Continuous Glucose Monitoring System and Gemini Glucose Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Senseonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Mellitus, Type 1; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: CTP-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes