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

NCT00682903 | Completed

• 1 other identifier: 2007/24
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Complications

Keywords

glucose; diabetes; glycemia

Outcome Measures

Primary Outcomes (1)

• 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

  glycemia

Study Arms (1)

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

Interventions

GuardianR DEVICE

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.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

CHU timone

Marseille, Bouches du Rhone, 13005, France

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: May 23, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

FR (1)