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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682903
First received: March 5, 2008
Last updated: January 29, 2010
Last verified: January 2010

March 5, 2008
January 29, 2010
January 2008
May 2012   (final data collection date for primary outcome measure)
The HbA1c, the witness of the quality of the metabolic balance, in 6 and 12 months. We shall compare the deltae of HbA1c between the period of inclusion and 6 and 12 months following the training course in the "fonctional" insulin therapy [ Time Frame: glycemia ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00682903 on ClinicalTrials.gov Archive Site
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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
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

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 to functional insulin therapy teaching. This concept of intensified treatment is based on testing and explanation of simplified decision making algorithms to adapt insulin dose to every true life conditions. As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.

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 a better glycemic control.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Complications
Device: GuardianR
As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.
Experimental: 1
This arm will benefit from the nonstop measure of the subcutaneous glucose during the hospitalization and the week on returning to the place of residence,
Intervention: Device: GuardianR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
122
December 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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)
Both
18 Years to 70 Years
No
Contact: Bernard VIALETTES, MD 44-9138-7576
France
 
NCT00682903
2007/24
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Not Provided
Assistance Publique Hopitaux De Marseille
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP