Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
NCT ID: NCT01443741
Last Updated: 2011-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
88 participants
INTERVENTIONAL
2012-01-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FIT Therapy
Patient with functional insulin therapy
Therapeutic education
Specific program for FIT Therapy and specific program for traditional way
Traditional way
Patient with traditional way
Therapeutic education
Specific program for FIT Therapy and specific program for traditional way
Interventions
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Therapeutic education
Specific program for FIT Therapy and specific program for traditional way
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
17 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Régis Coutant, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UH Angers
Locations
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University Hospital of Lyon
Lyon, Auvergne-Rhône-Alpes, France
University Hospital of Brest
Brest, Brittany Region, France
University Hospital of Tours
Tours, Centre-Val de Loire, France
University Hospital of Toulouse
Toulouse, Midi-Pyrénées, France
University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
Angers, Pays de Loire, France
University Hospital of Nantes
Nantes, Pays de Loire, France
Countries
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Central Contacts
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Facility Contacts
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Marc Nicolino, MD-PhD
Role: primary
Chantal Metz, MD
Role: primary
Myriam Pépin-Donat, MD
Role: primary
Claire Le Tallec, MD
Role: primary
Regis Coutant, MD-PhD
Role: primary
Natacha Bouhours-Nouet, MD
Role: backup
Sabine Baron, MD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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PHRC 2009- 03
Identifier Type: -
Identifier Source: org_study_id