Status:

COMPLETED

Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months

Lead Sponsor:

Assistance Publique Hopitaux De Marseille

Conditions:

Diabetes Complications

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

The objective of the project is to evaluate advantages from the use of a bearable continuous interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic patients dedicated...

Detailed Description

Two groups of 60 patients (experimental and control groups) will be followed and evaluated at 6 and 12 months. We do think that this new tool would facilitate education of patients and lead further to...

Eligibility Criteria

Inclusion

  • Subject major, from 18 to 70 years old
  • Diabetes of type 1 defined according to the criteria of American Diabetes Association
  • Insulinic treatment for at least 12 months
  • Understood HbA1C enters 6,5 and 9,5 %

Exclusion

  • Minor subjects or under guardianship
  • Unbalance kétosis current or recent
  • Pregnancy
  • Incapacitated to participate weekly complete educational in the functional insulin-therapy,
  • Evolutionary severe general disease
  • Psychiatric confusions
  • Unbalance chronic (HbA1c \> 9,5 %) connected to an absence of adapted coverage or to abnormal behaviors
  • Pathology making not interpretable the rate of HbA1c (hemoglobinopathy, anemia)

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT00682903

Start Date

January 1 2008

End Date

February 1 2011

Last Update

August 28 2014

Active Locations (1)

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CHU timone

Marseille, Bouches du Rhone, France, 13005