Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System (GLUCO FLASH)

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

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.

Study Overview

• Status: Terminated
• Conditions: Insulin-Dependent Diabetes
• Intervention / Treatment: Device: FreeStyle Libre™ system; Procedure: Finger prick

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): August 23, 2017
• Study Completion (Actual): August 23, 2017

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: LOCAL/2016/MR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No