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Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control, hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with insulin pump.
Open multicenter randomized study of one year, evaluating two groups of 44 children with diabetes mellitus (diabetes over 1 year) treated with insulin pump, one group by traditional way (fixed doses of insulin and meals providing stable quantities complex carbohydrates) and the other group by FIT Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIT Therapy | Active Comparator | Patient with functional insulin therapy |
|
| Traditional way | Active Comparator | Patient with traditional way |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic education | Other | Specific program for FIT Therapy and specific program for traditional way |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation in HbA1c | Variation in HbA1c from baseline in the study (M0) and 1 year later the beginning of the program (M12) for assess the importance of the FIT Therapy to improve metabolic control of children with diabetes mellitus treated with subcutaneous insulin pump. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Severe hypoglycemia over 6 months and quality of life | Number of severe hypoglycemia over 6 months (M6 to M12 and evolution of quality of life assessed by validated questionnaries in children with diabetes (WHO questionnary items 5, 27 KIDSCREEN questionnary, DISABKID questionnary). | One year and six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Régis Coutant, MD PhD | Contact | 33(2)41-35-56-55 | ReCoutant@chu-angers.fr | |
| Natacha Bouhours-Nouet, MD | Contact | 33(2)41-35-44-06 | NaBouhours-Nouet@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Régis Coutant, MD PhD | UH Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Lyon | Lyon | Auvergne-Rhône-Alpes | 69000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9306036 | Background | Langewitz W, Wossmer B, Iseli J, Berger W. Psychological and metabolic improvement after an outpatient teaching program for functional intensified insulin therapy (FIT). Diabetes Res Clin Pract. 1997 Sep;37(3):157-64. doi: 10.1016/s0168-8227(97)00071-5. | |
| 12629448 | Background | Hartemann-Heurtier A, Sachon C, Masseboeuf N, Corset E, Grimaldi A. Functional intensified insulin therapy with short-acting insulin analog: effects on HbA1c and frequency of severe hypoglycemia. An observational cohort study. Diabetes Metab. 2003 Feb;29(1):53-7. doi: 10.1016/s1262-3636(07)70007-1. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| University Hospital of Brest | Brest | Brittany Region | 29200 | France |
|
| University Hospital of Tours | Tours | Centre-Val de Loire | 37000 | France |
|
| University Hospital of Toulouse | Toulouse | Midi-Pyrénées | 31059 | France |
|
| University Hospital of Angers Service of Pediatric Diabetology and Endocrinology | Angers | Pays de Loire | 49933 | France |
|
| University Hospital of Nantes | Nantes | Pays de Loire | 44093 | France |
|
| 16132954 | Background | Samann A, Muhlhauser I, Bender R, Kloos Ch, Muller UA. Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study. Diabetologia. 2005 Oct;48(10):1965-70. doi: 10.1007/s00125-005-1905-1. Epub 2005 Aug 18. |
| 18353485 | Background | Lowe J, Linjawi S, Mensch M, James K, Attia J. Flexible eating and flexible insulin dosing in patients with diabetes: Results of an intensive self-management course. Diabetes Res Clin Pract. 2008 Jun;80(3):439-43. doi: 10.1016/j.diabres.2008.02.003. Epub 2008 Mar 18. |
| 15671916 | Background | Grimm JJ, Ybarra J, Berne C, Muchnick S, Golay A. A new table for prevention of hypoglycaemia during physical activity in type 1 diabetic patients. Diabetes Metab. 2004 Nov;30(5):465-70. doi: 10.1016/s1262-3636(07)70144-1. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |