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

C

Centre Hospitalier Universitaire de Nīmes

Status

Terminated

Conditions

Insulin-Dependent Diabetes

Treatments

Device: FreeStyle Libre™ system
Procedure: Finger prick

Study type

Interventional

Funder types

Other

Identifiers

NCT03411460
LOCAL/2016/MR-01

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Interstitial glucose
Experimental group
Description:
Glucose level tested by continuous monitoring device
Treatment:
Device: FreeStyle Libre™ system
Blood glucose
Active Comparator group
Description:
Glucose level tested on glucose monitor using standard finger prick
Treatment:
Procedure: Finger prick

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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