Diabetes Insulin Dependent Clinical Trial
— DIABFITOfficial title:
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.
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.
| Status | Not yet recruiting |
| Enrollment | 88 |
| Est. completion date | July 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 17 Years |
| Eligibility |
Inclusion Criteria: - aged 1-17 years - diabetic for at least 1 year - whose HbA1c is between 7.6 and 10% (7.6% <HbA1C <10%) - treated with insulin pump - agreeing to perform at least three blood glucose/day - willing to follow the treatment with functional insulin therapy if necessary Exclusion Criteria: - Ages <1 year or> 17 years - Duration of diabetes <1 year - HbA1c <7.6% or HbA1c> 10% - Treatment-by multiple injections - Mental disability - Refusal to adhere to the constraints of the study - Language barrier, preventing any understanding or cooperation - Eating behavior-type anorexia or bulimia - Pregnancy - Use of alcohol or drugs - Severe chronic or genetic pathology other than diabetes - Participation in another clinical study or refusal to participate in the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Angers Service of Pediatric Diabetology and Endocrinology | Angers | Pays de Loire |
| France | University Hospital of Brest | Brest | Bretagne |
| France | University Hospital of Lyon | Lyon | Rhône Alpes |
| France | University Hospital of Nantes | Nantes | Pays de Loire |
| France | University Hospital of Toulouse | Toulouse | Midi-Pyrénées |
| France | University Hospital of Tours | Tours | Région Centre |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers |
France,
Grimm JJ, Ybarra J, Berné 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. — View Citation
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. — View Citation
Langewitz W, Wössmer 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. — View Citation
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. — View Citation
Sämann A, Mühlhauser I, Bender R, Kloos Ch, Müller 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. Epub 2005 Aug 18. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |