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

Completed

Conditions: diabetes
Diabetes type 1
10018424

Registration Number: NL-OMON40657

Lead Sponsor: Senseonics, Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Males and Females Aged *18 years of age.
2. 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).
3. Subject understands study procedures and risks, is willing to comply with protocol requirements, and has signed an informed consent document.

Exclusion Criteria

1. History of severe hypoglycemia in the last 6 months prior to study start.
2. Severe diabetic ketoacidosis in the past 6 months.
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
4. 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.
5. Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active nonproliferative retinopathy, diabetic nephropathy including active retinopathy, or neuropathy.
6. Hematocrit >50% or <30%
7. Females pregnant or intending to become pregnant during the course of the investigation.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean absolute relative difference (MARD) of Sensor readings compared with the<br /><br>reference measurements (YSI) at successive 30-days intervals through 180 days<br /><br>post-insertion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Additional accuracy measures during the period of Sensor use * mean absolute<br /><br>difference; median absolute relative difference; agreement as expressed by<br /><br>readings within 20%, 30% and 40% of reference values; trend accuracy measured<br /><br>over time at different glucose rates of change and starting ranges.<br /><br>2. Clarke Error Grid, Consensus Error Grid and Continuous Glucose Error Grid.<br /><br>3. Deming regression analysis<br /><br>4. Bland Altman analysis<br /><br>5. Low/High glucose alert/alarm performance * accuracy of detection of hypo-<br /><br>and hyperglycemic states; sensitivity and specificity.<br /><br>(The glucose alert and alarm performance of the Senseonics CGM System will be<br /><br>evaluated through post-processing of data collected)</p><br>