Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

NCT05131139 | Unknown DMC FDA Device

• 1 other identifier: CTP-0041
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

Brief Summary

A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.

  The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 365 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively.

  365 days

• Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.

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

  365 days

Study Arms (1)

Continuous Glucose Monitoring Device

EXPERIMENTAL

Eversense 524 CGM System and ROME CGM System.

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

Eversense 524 CGM System and ROME CGM System.

Continuous Glucose Monitoring Device

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥14 years of age
• Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 years and older
• Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old
• 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.

You may not qualify if:

• History of unexplained 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 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.
• 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)
• For subjects inserted with the ROME CGM System: 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 (4)

AMCR Institute Inc.

Escondido, California, 92025, United States

RECRUITING

Rocky Mountain Diabetes Center, LLC. (RMDC)

Idaho Falls, Idaho, 83404, United States

RECRUITING

Clinical Trials of Texas, LLC. (CTT)

San Antonio, Texas, 78229, United States

RECRUITING

Rainier Clinical Research Center

Renton, Washington, 98057, 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

Katherine Tweden

CONTACT

240-624-2602; katherine.tweden@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: November 10, 2021
• First Posted: November 23, 2021
• Study Start: October 20, 2021
• Primary Completion: March 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)