Diabetes Insulin Dependent
Conditions
Keywords
FIT Therapy, Diabetes mellitus, Insulin pump, Pediatric
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.
Interventions
OTHERTherapeutic education
Specific program for FIT Therapy and specific program for traditional way
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation in HbA1c | One year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe hypoglycemia over 6 months and quality of life | One year and six months | 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). |
Countries
France
Contacts
Primary ContactRégis Coutant, MD PhD
Backup ContactNatacha Bouhours-Nouet, MD
Outcome results
None listed