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.

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Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU timone

Marseille, Bouches du Rhone, 13005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: May 23, 2008
Registry last updated: Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed