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
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
CHU Nimes🇫🇷Nîmes, France