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Clinical Trial NCT02647905 (PRECISEII) for Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII) 90
Clinical Trial NCT02647905 (PRECISEII) was an interventional study for Diabetes Mellitus that is now completed. The study started on January 1, 2016, with plans to enroll 90 participants. Led by Senseonics, Inc., the expected completion date was July 1, 2016. The latest data from ClinicalTrials.gov was last updated on June 6, 2018.
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.
Official Title
A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
Conditions
Diabetes MellitusOther Study IDs
- PRECISEII
- CTP-0023
NCT ID Number
Start Date (Actual)
2016-01
Last Update Posted
2018-06-06
Completion Date (Estimated)
2016-07
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
type 1 diabetes
type 2 diabetes
CGM
implantable
accuracy
longevity
type 2 diabetes
CGM
implantable
accuracy
longevity
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAccuracy assessment, CGMS To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days | Continuous Glucose Monitoring System Accuracy and safety assessment of a continuous glucose monitoring device |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
CGM Relative Difference to Laboratory Reference Reported as MARD | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. | 90 days |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- History of 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
- 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 >55%
- History of hepatitis B, hepatitis C, or HIV
- 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.
Senseonics, Inc.No contact data.
9 Study Locations in 1 Countries
California
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States
AMCR Institute, Escondido, California, 92025, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Georgia
Atlanta Diabetes Care, Atlanta, Georgia, 30318, United States
New York
Mount Sinai Diabetes Center, New York, New York, 10029, United States
Texas
Worldwide Clinical Trials, San Antonio, Texas, 78217, United States
Clinical Trials of Texas, San Antonio, Texas, 78229, United States
Virginia
UVA Diabetes and Endocrine Clinic, Charlottesville, Virginia, 22903, United States
Washington
Rainier Clinical Research, Renton, Washington, 98057, United States