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

Not Applicable

Completed

Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1

Interventions: Device: Continuous Glucose Monitoring System

Registration Number: NCT03808376

Lead Sponsor: Senseonics, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 208

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitoring Device	Continuous Glucose Monitoring System	The Eversense® 180 CGM System

Primary Outcome Measures

Name	Time	Method
Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events	180 days	Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure.
Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements	180 days	The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM \\| (Glucose)sensor - (Glucose)reference \\| / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (8): Atlanta Diabetes Care
🇺🇸
Atlanta, Georgia, United States
Barbara Davis Center for Diabetes
🇺🇸
Aurora, Colorado, United States
John Muir Physician Network Clinical Research Center
🇺🇸
Concord, California, United States
AMCR Institute Inc.
🇺🇸
Escondido, California, United States
Rocky mountain Diabetes Center C/O Research Department
🇺🇸
Idaho Falls, Idaho, United States
Diablo Clinical Research
🇺🇸
Walnut Creek, California, United States
Rainier Clinical Research Center
🇺🇸
Renton, Washington, United States
Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States