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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

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
NameTimeMethod
Satisfaction of patient-determined hospital care at discharge in the two groupsat discharge from hospital; maximum Day 5

visual analogue scale 0-10

Secondary Outcome Measures
NameTimeMethod
Patient quality of sleepat each day of hospitalization and discharge; maximum Day 5

Spiegel questionnaire

Satisfaction of nursing staff concerning care of patientat end of study; maximum Day 5

visual analogue scale response to 5 quesions

Time taken by nurse to measure circulating glucose levelDaily over length of hospitalization until maximum Day 5

in minutes

Time necessary to achieve satisfactory equilibrium using insulin pumpmaximum 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 staymaximum Day 5
Number of hypoglycmic events with the corresponding glucose levelmaximum Day 5
Patient satisfaction concerning treatment for their diabetesat discharge from hospital; maximum Day 5

Diabetes Treatment Satisfaction Questionnaire

Trial Locations

Locations (1)

CHU Nimes

🇫🇷

Nîmes, France

CHU Nimes
🇫🇷Nîmes, France
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