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Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent (DIABFIT)

Primary Purpose

Diabetes Insulin Dependent

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Therapeutic education
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Insulin Dependent focused on measuring FIT Therapy, Diabetes mellitus, Insulin pump, Pediatric

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Brest
  • University Hospital of Toulouse
  • University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
  • University Hospital of Nantes
  • University Hospital of Lyon
  • University Hospital of Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FIT Therapy

Traditional way

Arm Description

Patient with functional insulin therapy

Patient with traditional way

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Severe hypoglycemia over 6 months and quality of life
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).

Full Information

First Posted
September 28, 2011
Last Updated
September 28, 2011
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01443741
Brief Title
Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
Acronym
DIABFIT
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Insulin Dependent
Keywords
FIT Therapy, Diabetes mellitus, Insulin pump, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FIT Therapy
Arm Type
Active Comparator
Arm Description
Patient with functional insulin therapy
Arm Title
Traditional way
Arm Type
Active Comparator
Arm Description
Patient with traditional way
Intervention Type
Other
Intervention Name(s)
Therapeutic education
Other Intervention Name(s)
Functional insulin therapy, Traditional way (fixed doses of insulin)
Intervention Description
Specific program for FIT Therapy and specific program for traditional way
Primary Outcome Measure Information:
Title
Variation in HbA1c
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Severe hypoglycemia over 6 months and quality of life
Description
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).
Time Frame
One year and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Régis Coutant, MD PhD
Phone
33(2)41-35-56-55
Email
ReCoutant@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha Bouhours-Nouet, MD
Phone
33(2)41-35-44-06
Email
NaBouhours-Nouet@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Régis Coutant, MD PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Brest
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal Metz, MD
Phone
(0)2 98 22 33 88
Ext
33
Email
chantal.metz@chu-brest.fr
Facility Name
University Hospital of Toulouse
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Le Tallec, MD
Phone
(0)5 34 55 85 64
Ext
33
Email
letallec.c@chu-toulouse.fr
Facility Name
University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
City
Angers
State/Province
Pays de Loire
ZIP/Postal Code
49933
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regis Coutant, MD-PhD
Phone
33(0)2-41-35-56-55
Email
ReCoutant@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Natacha Bouhours-Nouet, MD
Phone
33(0)2-41-35-44-06
Email
NaBouhours-Nouet@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Natacha Bouhours-Nouet, MD
First Name & Middle Initial & Last Name & Degree
Sylvie Dufresne, MD
First Name & Middle Initial & Last Name & Degree
Frédérique Gatelais, MD
Facility Name
University Hospital of Nantes
City
Nantes
State/Province
Pays de Loire
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Baron, MD
Phone
(0)2 40 08 33 33
Ext
33
Email
sabine.baron@chu-nantes.fr
Facility Name
University Hospital of Lyon
City
Lyon
State/Province
Rhône Alpes
ZIP/Postal Code
69000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Nicolino, MD-PhD
Phone
(0)4 72 38 58 73
Ext
33
Email
marc.nicolino@chu-lyon.fr
Facility Name
University Hospital of Tours
City
Tours
State/Province
Région Centre
ZIP/Postal Code
37000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam Pépin-Donat, MD
Phone
(0)2 47 47 38 68
Ext
33
Email
m.pepin-donat@chu-tours.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
9306036
Citation
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.
Results Reference
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PubMed Identifier
12629448
Citation
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.
Results Reference
background
PubMed Identifier
16132954
Citation
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.
Results Reference
background
PubMed Identifier
18353485
Citation
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.
Results Reference
background
PubMed Identifier
15671916
Citation
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.
Results Reference
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Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent

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