RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-20

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05131139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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.	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)

Inclusion Criteria

Exclusion Criteria

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.

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)

Contacts and Locations

Study Contact

Maggie Lewis

CONTACT

667-218-3309

maggie.lewis@senseonics.com

Katherine Tweden

CONTACT

240-624-2602

katherine.tweden@senseonics.com

Study Locations (Sites)

AMCR Institute Inc.

Escondido, California, 92025

United States

Rocky Mountain Diabetes Center, LLC. (RMDC)

Idaho Falls, Idaho, 83404

United States

Clinical Trials of Texas, LLC. (CTT)

San Antonio, Texas, 78229

United States

Rainier Clinical Research Center

Renton, Washington, 98057

United States

Collaborators and Investigators

Sponsor: Senseonics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-20

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2021-10-20

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

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