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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitoring System
Sponsored by
Senseonics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

  1. Subjects greater than or equal to18 years of age
  2. Clinically confirmed diagnosis of diabetes mellitus for greater than or equal to 1 year.
  3. Subject has signed an informed consent form 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 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 not surgically sterile or not menopausal for greater than 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 within 6 months; uncontrolled hypertension (systolic greater than 160 mm HG or diastolic greater than100 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 less than 38% or greater than 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; antibiotics for chronic infection (e.g.

    osteomyelitis, endocarditis)

  12. Known topical or local anesthetic allergy
  13. Known allergy to glucocorticoids
  14. 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

  15. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
  16. The presence of any other active implanted device

Sites / Locations

  • AMCR Institute Inc.Recruiting
  • Rocky Mountain Diabetes Center, LLC. (RMDC)Recruiting
  • Clinical Trials of Texas, LLC. (CTT)Recruiting
  • Rainier Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous Glucose Monitoring Device

Arm Description

Eversense 524 CGM System and ROME CGM System.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
November 10, 2021
Last Updated
April 24, 2023
Sponsor
Senseonics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05131139
Brief Title
Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
Official Title
Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senseonics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitoring Device
Arm Type
Experimental
Arm Description
Eversense 524 CGM System and ROME CGM System.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring System
Intervention Description
Eversense 524 CGM System and ROME CGM System.
Primary Outcome Measure Information:
Title
Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.
Description
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.
Time Frame
365 days
Title
Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.
Description
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study: 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. Exclusion Criteria: Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study: 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 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 Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period The presence of any other active implanted device (as defined further in protocol)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maggie Lewis
Phone
667-218-3309
Email
maggie.lewis@senseonics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Tweden
Phone
240-624-2602
Email
katherine.tweden@senseonics.com
Facility Information:
Facility Name
AMCR Institute Inc.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Bailey, MD
Phone
877-567-2627
Email
tbailey@amcrinstitute.com
Facility Name
Rocky Mountain Diabetes Center, LLC. (RMDC)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Sulik
Phone
208-523-1122
Email
mark@idahomed.com
First Name & Middle Initial & Last Name & Degree
Joseph Rogers
Phone
208-523-1122
Email
joseph.rogers@idahomed.com
First Name & Middle Initial & Last Name & Degree
David Liljenquist
Facility Name
Clinical Trials of Texas, LLC. (CTT)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelbie Martin
Phone
210-949-0122
Ext
161
First Name & Middle Initial & Last Name & Degree
Sierra Wilson
Phone
210-949-0122
Ext
208
Email
swilson@cttexas.com
First Name & Middle Initial & Last Name & Degree
Douglas S Denham, DO
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Brazg, MD
Phone
425-251-1720
Ext
313
Email
rbrazg@rainier-research.com
First Name & Middle Initial & Last Name & Degree
Tina Mitchell
Phone
425-251-1720
Email
tmitchell@rainer-research.com
First Name & Middle Initial & Last Name & Degree
Ronald Brazg, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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