Clinical trial NCT01443741: Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
Official 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Insulin Dependent
Keywords: FIT Therapy
Diabetes mellitus
Insulin pump
Pediatric
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-09-30
Enrollment: 88
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation in HbA1c
timeFrame: One year
Secondary outcomes:
measure: Severe hypoglycemia over 6 months and quality of life
timeFrame: One year and six months
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital of Brest
state: Bretagne
city: Toulouse
country: France
facility: University Hospital of Toulouse
state: Midi-Pyrénées
city: Angers
country: France
facility: University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
state: Pays de Loire
city: Nantes
country: France
facility: University Hospital of Nantes
state: Pays de Loire
city: Lyon
country: France
facility: University Hospital of Lyon
state: Rhône Alpes
city: Tours
country: France
facility: University Hospital of Tours
state: Région Centre
Study officials:
affiliation: UH Angers
name: Régis Coutant, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s1262-3636(07)70007-1.
citation: 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.
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.
citation: 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.