Function of Implanted Glucose Sensor 2

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-05-30

Brief Summary

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The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.

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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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Study Group

Device: Model 100 Sensor

Group Type EXPERIMENTAL

Model 100 Sensor

Intervention Type DEVICE

One Model 100 Sensor to be implanted per subject.

Interventions

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Model 100 Sensor

One Model 100 Sensor to be implanted per subject.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant
* Diabetes diagnosis of type 1, or type 2 using insulin
* Under the routine care of a physician for diabetes treatment
* Able to understand and follow directions
* History of compliance with diabetes care regimen
* Able to comply with study requirements regarding planned clinical visits and exams
* In good physical condition without major medical concerns or blood chemistry abnormalities

Exclusion Criteria

* Mental disorders that might affect compliance to protocols
* Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone
* History of intolerance or sensitivity to any of the device materials
* History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures
* History of recurrent skin infections

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes