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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Accuracy assessment

Group Type OTHER

Continuous Glucose Monitoring Device (Senseonics)

Intervention Type DEVICE

Interventions

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Continuous Glucose Monitoring Device (Senseonics)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No