Diabetes Insulin Dependent | Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
Diabetes Insulin Dependent research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Diabetes Insulin Dependent
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Therapeutic educationSpecific program for FIT Therapy and specific program for traditional way
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FIT TherapyPatient with functional insulin therapy
Traditional wayPatient with traditional way
Start Date: January 2012
Completed Date: July 2015
Phase: Phase 2
Primary Outcome: Variation in HbA1c
Secondary Outcome: Severe hypoglycemia over 6 months and quality of life
Study sponsors, principal investigator, and references
Principal Investigator: Régis Coutant, MD PhD
Lead Sponsor: University Hospital, Angers
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.