Insulin-Dependent Diabetes
Conditions
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.
Interventions
DEVICEFreeStyle Libre™ system
Measured non-invasively via scanner
PROCEDUREFinger prick
Blood test
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient satisfaction concerning treatment for their diabetes | at discharge from hospital; maximum Day 5 | Diabetes Treatment Satisfaction Questionnaire |
| 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 | — |
| Time necessary to achieve satisfactory equilibrium using insulin pump | maximum Day 5 | average daily glucose level \< 1.50 g/l |
Countries
France
Outcome results
None listed