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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB : 2011-A00645-36 | Other Identifier | Afssaps |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes patient | Experimental | Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education to Functional Insulin Therapy | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between HbA1c at Month 12 and Month 0 > 0.5% | at baseline et at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between HbA1c at Month 3 and Month 0 > 0.3% | at baseline et at Month 3 | |
| Difference between HbA1c at Month 6 and Month 0 > 0.5% | at baseline and at Month 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric ER RENARD, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Montpellier | 34000 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Difference between HbA1c at Month 9 and Month 0 > 0.5% |
| at baseline and at Month 9 |
| Reduction of 50% of hypoglycemia < 60mg/dl | at Month 12 |
| Reduction of 30% of hypoglycemia between 60 and 80mg/dl | at Month 12 |
| Reduction of number of patients who have severe hypoglycemia | at MONTH 12 |
| Better score at surveys of quality of life (SF-6D, DQOL) and auto-management | at baseline, at Month 6 and at Month 12 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |