Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

NCT03411460 | Terminated

• 1 other identifier: LOCAL/2016/MR-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin-Dependent Diabetes

Outcome Measures

Primary Outcomes (1)

• Satisfaction of patient-determined hospital care at discharge in the two groups

  visual analogue scale 0-10

  at discharge from hospital; maximum Day 5

Secondary Outcomes (7)

• Patient satisfaction concerning treatment for their diabetes

  at discharge from hospital; maximum Day 5

• Patient quality of sleep

  at each day of hospitalization and discharge; maximum Day 5

• Satisfaction of nursing staff concerning care of patient

  at end of study; maximum Day 5

• Time taken by nurse to measure circulating glucose level

  Daily over length of hospitalization until maximum Day 5

• Time necessary to achieve satisfactory equilibrium using insulin pump

  maximum Day 5

Study Arms (2)

Interstitial glucose

EXPERIMENTAL

Glucose level tested by continuous monitoring device

Device: FreeStyle Libre™ system

Blood glucose

ACTIVE COMPARATOR

Glucose level tested on glucose monitor using standard finger prick

Procedure: Finger prick

Interventions

FreeStyle Libre™ system DEVICE

Measured non-invasively via scanner

Interstitial glucose

Finger prick PROCEDURE

Blood test

Blood glucose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The subject is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: January 26, 2018
• Study Start: April 19, 2017
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: January 26, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)