Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

Study Overview
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Brief Summary
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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.

Official Title
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Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump

Conditions
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Insulin-Dependent Diabetes

Intervention / Treatment
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* Device: FreeStyle Libre™ system
* Procedure: Finger prick


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interstitial glucose<br>Glucose level tested by continuous monitoring device | Device: FreeStyle Libre™ system<br>* Measured non-invasively via scanner<br>|
| Active Comparator: Blood glucose<br>Glucose level tested on glucose monitor using standard finger prick | Procedure: Finger prick<br>* Blood test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction concerning treatment for their diabetes | Diabetes Treatment Satisfaction Questionnaire | at discharge from hospital; maximum Day 5 | 
| Patient quality of sleep | Spiegel questionnaire | at each day of hospitalization and discharge; maximum Day 5 | 
| Satisfaction of nursing staff concerning care of patient | visual analogue scale response to 5 quesions | at end of study; maximum Day 5 | 
| Time taken by nurse to measure circulating glucose level | in minutes | Daily over length of hospitalization until maximum Day 5 | 
| Time necessary to achieve satisfactory equilibrium using insulin pump | average daily glucose level < 1.50 g/l | maximum Day 5 | 
| 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 |