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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

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
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Complications
 Device: GuardianR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 122
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,
 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.

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 a better glycemic control.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682903

Contacts
Contact: Bernard VIALETTES, MD 44-9138-7576

Locations
France
CHU timone Recruiting
Marseille, Bouches du Rhone, France, 13005
Contact: bernard Vialettes, MD     44-9138-7576        
Principal Investigator: bernard vialettes, md            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00682903     History of Changes
Other Study ID Numbers: 2007/24
Study First Received: March 5, 2008
Last Updated: January 29, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
glucose
diabetes
glycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Stress, Psychological
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 17, 2013