Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

Not Applicable

Terminated

• Conditions: Insulin-Dependent Diabetes

• Registration Number: NCT03411460
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-04-19
• Study First Submitted: 2017-06-16
• Primary Completion: 2017-08-23
• Study Completion: 2017-08-23
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Satisfaction of patient-determined hospital care at discharge in the two groups	at discharge from hospital; maximum Day 5	visual analogue scale 0-10

Secondary Outcome Measures

Name	Time	Method
Patient quality of sleep	at each day of hospitalization and discharge; maximum Day 5	Spiegel questionnaire
Satisfaction of nursing staff concerning care of patient	at end of study; maximum Day 5	visual analogue scale response to 5 quesions
Time taken by nurse to measure circulating glucose level	Daily over length of hospitalization until maximum Day 5	in minutes
Time necessary to achieve satisfactory equilibrium using insulin pump	maximum Day 5	average daily glucose level \< 1.50 g/l
Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay	maximum Day 5
Number of hypoglycmic events with the corresponding glucose level	maximum Day 5
Patient satisfaction concerning treatment for their diabetes	at discharge from hospital; maximum Day 5	Diabetes Treatment Satisfaction Questionnaire

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France