PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

Study Overview
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Brief Summary
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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 (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

Official Title
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PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitoring Device (Senseonics)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects meeting all of the following inclusion criteria will be included in this study: Males and females ≥18 years of age Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy) Subject has signed an informed consent document and is willing to comply with protocol requirements Exclusion Criteria: Subjects meeting any of the following exclusion criteria will be excluded from this study: History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure Diabetic ketoacidosis in the past 6 months Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy including active retinopathy Hematocrit >50% or <30% Females lactating or pregnant or intending to become pregnant during the course of the investigation A condition requiring or likely to require magnetic resonance imaging

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Accuracy assessment<br> | Device: Continuous Glucose Monitoring Device (Senseonics)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (mean absolute relative difference) compared to be reference device should be less than 20% | To determine accuracy of the Senseonics CGM System measurements over successive periods of 30 days of Sensor use through 180 days post-insertion. | 90 days |