Back to resultsSatisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System (GLUCO FLASH)
Primary Purpose
Insulin-Dependent Diabetes
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FreeStyle Libre™ system
Finger prick
Sponsored by
About this trial
This is an interventional supportive care trial for Insulin-Dependent Diabetes
Eligibility Criteria
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
Sites / Locations
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interstitial glucose
Blood glucose
Arm Description
Glucose level tested by continuous monitoring device
Glucose level tested on glucose monitor using standard finger prick
Outcomes
Primary Outcome Measures
Satisfaction of patient-determined hospital care at discharge in the two groups
visual analogue scale 0-10
Secondary Outcome Measures
Patient satisfaction concerning treatment for their diabetes
Diabetes Treatment Satisfaction Questionnaire
Patient quality of sleep
Spiegel questionnaire
Satisfaction of nursing staff concerning care of patient
visual analogue scale response to 5 quesions
Time taken by nurse to measure circulating glucose level
in minutes
Time necessary to achieve satisfactory equilibrium using insulin pump
average daily glucose level < 1.50 g/l
Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay
Number of hypoglycmic events with the corresponding glucose level
Full Information
NCT ID
NCT03411460
First Posted
June 16, 2017
Last Updated
January 25, 2018
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03411460
Brief Title
Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System
Acronym
GLUCO FLASH
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
logistical difficulties
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
August 23, 2017 (Actual)
Study Completion Date
August 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin-Dependent Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interstitial glucose
Arm Type
Experimental
Arm Description
Glucose level tested by continuous monitoring device
Arm Title
Blood glucose
Arm Type
Active Comparator
Arm Description
Glucose level tested on glucose monitor using standard finger prick
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre™ system
Intervention Description
Measured non-invasively via scanner
Intervention Type
Procedure
Intervention Name(s)
Finger prick
Intervention Description
Blood test
Primary Outcome Measure Information:
Title
Satisfaction of patient-determined hospital care at discharge in the two groups
Description
visual analogue scale 0-10
Time Frame
at discharge from hospital; maximum Day 5
Secondary Outcome Measure Information:
Title
Patient satisfaction concerning treatment for their diabetes
Description
Diabetes Treatment Satisfaction Questionnaire
Time Frame
at discharge from hospital; maximum Day 5
Title
Patient quality of sleep
Description
Spiegel questionnaire
Time Frame
at each day of hospitalization and discharge; maximum Day 5
Title
Satisfaction of nursing staff concerning care of patient
Description
visual analogue scale response to 5 quesions
Time Frame
at end of study; maximum Day 5
Title
Time taken by nurse to measure circulating glucose level
Description
in minutes
Time Frame
Daily over length of hospitalization until maximum Day 5
Title
Time necessary to achieve satisfactory equilibrium using insulin pump
Description
average daily glucose level < 1.50 g/l
Time Frame
maximum Day 5
Title
Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay
Time Frame
maximum Day 5
Title
Number of hypoglycmic events with the corresponding glucose level
Time Frame
maximum Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System
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