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

This study is currently recruiting participants.

Verified by Assistance Publique Hopitaux De Marseille, October 2008

First Received: March 5, 2008 Last Updated: October 14, 2008 History of Changes

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00682903

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

MedlinePlus related topics: Diabetes Diabetes Complications Diabetes Type 1

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Historical Control, Parallel Assignment
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

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
1: Experimental 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, Bouches du Rhone
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 ( Assistance Publique Hopitaux De Marseille )
Study ID Numbers:	2007/24
Study First Received:	March 5, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00682903 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique Hopitaux De Marseille:

glucose
diabetes
glycemia

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin
Diabetes Complications

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on May 07, 2009