Diabetes Complications
Conditions
Keywords
glucose, diabetes, glycemia
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.
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.
Interventions
DEVICEGuardianR
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.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed