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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131139
• Other study ID #: CTP-0041
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2023
• Source: Senseonics, Inc.
• Contact: Maggie Lewis
• Phone: 667-218-3309
• Email: maggie.lewis[@]senseonics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

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

1. Subjects =14 years of age

2. Clinically confirmed diagnosis of diabetes mellitus for =1 year for adults 18 years and older

3. Clinically confirmed diagnosis of type I diabetes mellitus for =1 year for adolescents 14 -17 years old

4. 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.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:

1. History of unexplained 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 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.

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. For subjects inserted with the ROME CGM System: 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 protocol)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Device:
• Continuous Glucose Monitoring System
Eversense 524 CGM System and ROME CGM System.

Locations

Country	Name	City	State
United States	AMCR Institute Inc.	Escondido	California
United States	Rocky Mountain Diabetes Center, LLC. (RMDC)	Idaho Falls	Idaho
United States	Rainier Clinical Research Center	Renton	Washington
United States	Clinical Trials of Texas, LLC. (CTT)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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