Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII)
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ClinicalTrials.gov Identifier: NCT02647905 |
Recruitment Status :
Completed
First Posted : January 6, 2016
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Device: Continuous Glucose Monitoring System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Accuracy 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
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Device: Continuous Glucose Monitoring System
Accuracy and safety assessment of a continuous glucose monitoring device |
- CGM Relative Difference to Laboratory Reference Reported as MARD [ Time Frame: 90 days ]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.
- CGM System Agreement With Reference Control [ Time Frame: 90 days ]The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647905
United States, California | |
John Muir Physician Network Clinical Research Center | |
Concord, California, United States, 94520 | |
AMCR Institute | |
Escondido, California, United States, 92025 | |
Diablo Clinical Research | |
Walnut Creek, California, United States, 94598 | |
United States, Georgia | |
Atlanta Diabetes Care | |
Atlanta, Georgia, United States, 30318 | |
United States, New York | |
Mount Sinai Diabetes Center | |
New York, New York, United States, 10029 | |
United States, Texas | |
Worldwide Clinical Trials | |
San Antonio, Texas, United States, 78217 | |
Clinical Trials of Texas | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
UVA Diabetes and Endocrine Clinic | |
Charlottesville, Virginia, United States, 22903 | |
United States, Washington | |
Rainier Clinical Research | |
Renton, Washington, United States, 98057 |
Principal Investigator: | Mark Christiansen, MD | Diablo Clinical Research |
Responsible Party: | Senseonics, Inc. |
ClinicalTrials.gov Identifier: | NCT02647905 |
Other Study ID Numbers: |
CTP-0023 |
First Posted: | January 6, 2016 Key Record Dates |
Results First Posted: | June 6, 2018 |
Last Update Posted: | June 6, 2018 |
Last Verified: | May 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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