PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.

Official Title
-----------------
PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days

Conditions
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects, age ≥18 years Clinically confirmed diagnosis of diabetes mellitus for ≥1 year Subject has signed an informed consent form and is willing to comply with protocol requirements Exclusion Criteria: 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 ≥ 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 <30% or >60% 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); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis) 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring Device<br>The Eversense® 180 CGM System | Device: Continuous Glucose Monitoring System<br>* The Eversense® 180 CGM System<br>* Other names: Eversense CGM system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Measure - mean absolute relative difference (MARD) | The effectiveness endpoint will be mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL. | 180 days | 
| Safety Endpoint - Incidence of device-related or sensor insertion/removal procedure-related serious adverse | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 180 days post-Sensor insertion or removal and follow-up. | 180 days |