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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Diabetes Complications

Treatments: Device: GuardianR

Study type: Interventional

Funder types: Other

Identifiers

NCT00682903

2007/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 1 patient group

1

Experimental group

Description:

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,

Treatment:

Device: GuardianR