Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.
Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
52
* Intake of Continuous Glucose Monitor for 5 to 7 days * "Functional Insulinotherapy" training during 3 days, blood sampling, autoevaluation and QOL questionnary. * 1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes * 3 months after the training: Blood sampling, vital signs and data on diabetes * 6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days * 9 months after the training: Blood sampling, vital signs and data on diabetes * 1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days * 12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary
Montpellier University Hospital
Montpellier, France
Difference between HbA1c at Month 12 and Month 0 > 0.5%
Time frame: at baseline et at Month 12
Difference between HbA1c at Month 3 and Month 0 > 0.3%
Time frame: at baseline et at Month 3
Difference between HbA1c at Month 6 and Month 0 > 0.5%
Time frame: at baseline and at Month 6
Difference between HbA1c at Month 9 and Month 0 > 0.5%
Time frame: at baseline and at Month 9
Reduction of 50% of hypoglycemia < 60mg/dl
Time frame: at Month 12
Reduction of 30% of hypoglycemia between 60 and 80mg/dl
Time frame: at Month 12
Reduction of number of patients who have severe hypoglycemia
Time frame: at MONTH 12
Better score at surveys of quality of life (SF-6D, DQOL) and auto-management
Time frame: at baseline, at Month 6 and at Month 12
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