Clinical trial NCT02647905: Evaluation of the Accuracy of an Implanted Glucose Sensor
Official title: A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: type 1 diabetes
type 2 diabetes
CGM
implantable
accuracy
longevity
Lead sponsor: Senseonics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 90
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 Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics 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 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. 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.
4. A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
5. 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.
6. Hematocrit \<30% or \>55%
7. History of hepatitis B, hepatitis C, or HIV
8. 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.

Primary outcomes:
measure: CGM Relative Difference to Laboratory Reference Reported as MARD
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
measure: CGM System Agreement With Reference Control
timeFrame: 90 days
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Care
state: Georgia
city: New York
country: United States
facility: Mount Sinai Diabetes Center
state: New York
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Charlottesville
country: United States
facility: UVA Diabetes and Endocrine Clinic
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research
state: Washington
Study officials:
affiliation: Diablo Clinical Research
name: Mark Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References: