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logistical difficulties
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The aim of the study is to establish whether routine usage of the FreeStyle Libreâ„¢ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interstitial glucose | Experimental | Glucose level tested by continuous monitoring device |
|
| Blood glucose | Active Comparator | Glucose level tested on glucose monitor using standard finger prick |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libreâ„¢ system | Device | Measured non-invasively via scanner |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Finger prick |
| Procedure |
Blood test |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |