Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System

Insulin-Dependent Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03411460
• Other study ID #: LOCAL/2016/MR-01
• Status: Terminated
• Phase: N/A
• First received: June 16, 2017
• Last updated: January 25, 2018
• Start date: April 19, 2017
• Est. completion date: August 23, 2017

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 23, 2017
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin-Dependent Diabetes

Intervention

Device:
• FreeStyle Libre™ system
Measured non-invasively via scanner

Procedure:
• Finger prick
Blood test

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction concerning treatment for their diabetes	Diabetes Treatment Satisfaction Questionnaire	at discharge from hospital; maximum Day 5
Secondary	Patient quality of sleep	Spiegel questionnaire	at each day of hospitalization and discharge; maximum Day 5
Secondary	Satisfaction of nursing staff concerning care of patient	visual analogue scale response to 5 quesions	at end of study; maximum Day 5
Secondary	Time taken by nurse to measure circulating glucose level	in minutes	Daily over length of hospitalization until maximum Day 5
Secondary	Time necessary to achieve satisfactory equilibrium using insulin pump	average daily glucose level < 1.50 g/l	maximum Day 5
Secondary	Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay		maximum Day 5
Secondary	Number of hypoglycmic events with the corresponding glucose level		maximum Day 5