A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring

NCT ID: NCT01942902

Last Updated: 2013-11-06

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.

Detailed Description

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Conditions

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Continuous Glucose Measurement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous Glucose Monitoring System

Group Type EXPERIMENTAL

Continuous Glucose Monitoring System

Intervention Type DEVICE

Interventions

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Continuous Glucose Monitoring System

Intervention Type DEVICE

Other Intervention Names

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Glysure

Eligibility Criteria

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Inclusion Criteria

1. Patient or legal representative MUST be willing to sign an informed consent document
2. Male and female aged 18 years and above
3. Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment
4. Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-

Exclusion Criteria

1. Patient or legal representative unable to provide written informed consent
2. Patient who is pregnant
3. Patient who is currently being administered Mannitol
4. Patient with history of Pulmonary Embolism (PE)
5. Patient with history of thrombosis
6. Patient with known hyper-coagulation
7. Patient with known history of heparin hypersensitivity
8. Patient with history of heparin induced thrombocytopenia
9. Participation in a clinical study involving an unlicensed pharmaceutical product and/or device within the 3 months prior to enrolment in this study
10. Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film
11. Patient likely to require an MRI scan during their stay in the SICU
12. Patients likely to require treatment with Mannitol during time in the SICU
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlySure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krishna Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Care Hospital

Locations

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Star Hospital

Banjara Hills, Hyderabad, India

Site Status

Care Hospital

Nampally, Hyderabad, India

Site Status

Countries

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India

Other Identifiers

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2013.01.CE

Identifier Type: -

Identifier Source: org_study_id