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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    120
  • sponsor
    Senseonics, Inc.
Updated on 29 May 2022
continuous glucose monitoring

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) with next generation feature enhancements compared to reference glucose measurements. The investigation will also evaluate safety of the Eversense 524 CGM System usage.

Details
Condition Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Treatment Continuous Glucose Monitoring System
Clinical Study IdentifierNCT05131139
SponsorSenseonics, Inc.
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects meeting all of the following inclusion criteria will be included in
this study
Subjects greater than or equal to18 years of age
Clinically confirmed diagnosis of diabetes mellitus for greater than or equal to 1 year
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
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 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
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 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
Hematocrit less than 38% or greater than 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; antibiotics for chronic infection (e.g
osteomyelitis, endocarditis)
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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