Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

NCT ID: NCT03411460

Last Updated: 2018-01-26

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

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2017-08-23

Brief Summary

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The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.

Detailed Description

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Conditions

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Insulin-Dependent Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Interstitial glucose

Glucose level tested by continuous monitoring device

Group Type EXPERIMENTAL

FreeStyle Libre™ system

Intervention Type DEVICE

Measured non-invasively via scanner

Blood glucose

Glucose level tested on glucose monitor using standard finger prick

Group Type ACTIVE_COMPARATOR

Finger prick

Intervention Type PROCEDURE

Blood test

Interventions

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FreeStyle Libre™ system

Measured non-invasively via scanner

Intervention Type DEVICE

Finger prick

Blood test

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient has given their free and informed consent
* The patient must be insured or the beneficiary of an insurance policy
* The patient is aged at least 18 years and less than 75 years old.
* Patients have a BMI between 18 and 40kg/m2
* Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state

Exclusion Criteria

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The patients is under judicial protection or state guardianship
* The subject refuses to sign the consent form
* It proves impossible to give the subject clear information.
* The patient is pregnant, parturient or breastfeeding
* The patient is clinically unstable
* BMI less than 18 or over 40
* Existence of a severe rapidly progressive ischemic retinopathy or proliferative retinopathy.
* Serious psychiatric problems
* Chronic cutaneous infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2016/MR-01

Identifier Type: -

Identifier Source: org_study_id

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