Status:
UNKNOWN
Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
Lead Sponsor:
University Hospital, Angers
Conditions:
Diabetes Insulin Dependent
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01443741
Start Date
January 1 2012
End Date
July 1 2015
Last Update
September 30 2011
Active Locations (6)
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1
University Hospital of Lyon
Lyon, Auvergne-Rhône-Alpes, France, 69000
2
University Hospital of Brest
Brest, Brittany Region, France, 29200
3
University Hospital of Tours
Tours, Centre-Val de Loire, France, 37000
4
University Hospital of Toulouse
Toulouse, Midi-Pyrénées, France, 31059