Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
DIABFIT
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.
1 other identifier
interventional
88
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 30, 2011
September 1, 2011
3 years
September 28, 2011
September 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Severe hypoglycemia over 6 months and quality of life
One year and six months
Study Arms (2)
FIT Therapy
ACTIVE COMPARATORPatient with functional insulin therapy
Traditional way
ACTIVE COMPARATORPatient with traditional way
Interventions
Specific program for FIT Therapy and specific program for traditional way
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University Hospital of Lyon
Lyon, Auvergne-Rhône-Alpes, 69000, France
University Hospital of Brest
Brest, Brittany Region, 29200, France
University Hospital of Tours
Tours, Centre-Val de Loire, 37000, France
University Hospital of Toulouse
Toulouse, Midi-Pyrénées, 31059, France
University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
Angers, Pays de Loire, 49933, France
University Hospital of Nantes
Nantes, Pays de Loire, 44093, France
Related Publications (5)
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.
PMID: 9306036BACKGROUNDHartemann-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.
PMID: 12629448BACKGROUNDSamann 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.
PMID: 16132954BACKGROUNDLowe 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.
PMID: 18353485BACKGROUNDGrimm 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.
PMID: 15671916BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Régis Coutant, MD PhD
UH Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
September 30, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2015
Study Completion
July 1, 2015
Last Updated
September 30, 2011
Record last verified: 2011-09