Clinical trial NCT03808376: PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
Official title: PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Senseonics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Adult subjects, age ≥18 years
2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
3. Subject has signed an informed consent form and is willing to comply with protocol requirements

Exclusion Criteria:

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 ≥ 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 \<30% or \>60%
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); 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)
12. 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)

Primary outcomes:
measure: Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements
timeFrame: 180 days
measure: Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Escondido
country: United States
facility: AMCR Institute Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Diabetes
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Care
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky mountain Diabetes Center C/O Research Department
state: Idaho
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Barbara Davis Center
name: Satish Garg, MD
role: PRINCIPAL_INVESTIGATOR
References: