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

Diabetes Mellitus Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154126
• Other study ID #: CTP-0004
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: January 19, 2016
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2015
• Source: Senseonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: BfArMNetherlands:IGZ
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects meeting all of the following inclusion criteria will be included in this study:

1. Males and females =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 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:

1. History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure

2. 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 non-proliferative retinopathy, diabetic nephropathy including active retinopathy

6. Hematocrit >50% or <30%

7. Females lactating or pregnant or intending to become pregnant during the course of the investigation

8. A condition requiring or likely to require magnetic resonance imaging

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitoring Device (Senseonics)

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No