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Status unknownNCT01443741DIABFITUpdated Sep 30, 2011

Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent

A Phase 2 interventional study of Therapeutic education in Diabetes Insulin Dependent, sponsored by University Hospital, Angers. Status unknown at 6 sites in France. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2011-09-30.

Sponsored by University Hospital, Angers · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
1 Year to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Insulin Dependent

Keywords

  • FIT Therapy
  • Diabetes mellitus
  • Insulin pump
  • Pediatric
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 88 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Active comparator
    FIT Therapy

    Patient with functional insulin therapy

    Other: Therapeutic education

  • Active comparator
    Traditional way

    Patient with traditional way

    Other: Therapeutic education

Interventions

  • OtherTherapeutic education

    Specific program for FIT Therapy and specific program for traditional way

    Also known as: Functional insulin therapy, Traditional way (fixed doses of insulin)

06

What researchers measure

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.

    Time frame: One year

Secondary outcomes

  1. 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).

    Time frame: One year and six months

07

Study locations

6 sites
  • University Hospital of Brest
    Brest, Bretagne 29200, 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
    • Regis Coutant, MD-PhD · Contact · ReCoutant@chu-angers.fr · 33(0)2-41-35-56-55
    • Natacha Bouhours-Nouet, MD · Contact · NaBouhours-Nouet@chu-angers.fr · 33(0)2-41-35-44-06
    • Natacha Bouhours-Nouet, MD · Sub investigator
    • Sylvie Dufresne, MD · Sub investigator
    • Frédérique Gatelais, MD · Sub investigator
  • University Hospital of Nantes
    Nantes, Pays de Loire 44093, France
  • University Hospital of Lyon
    Lyon, Rhône Alpes 69000, France
  • University Hospital of Tours
    Tours, Région Centre 37000, France
08

References and documents

Publications

  • 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. PubMed 9306036 ↗
  • 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. PubMed 12629448 ↗
  • 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. PubMed 16132954 ↗
  • 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. PubMed 18353485 ↗
  • 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. PubMed 15671916 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01443741
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Sep 30, 2011
Start date
Jan 2012
Primary completion
Jan 2015 (estimated)
Completion
Jul 2015 (estimated)
Last update
Sep 30, 2011

Study contacts

Régis Coutant, MD PhD
Contact
ReCoutant@chu-angers.fr
33(2)41-35-56-55
Natacha Bouhours-Nouet, MD
Contact
NaBouhours-Nouet@chu-angers.fr
33(2)41-35-44-06
Régis Coutant, MD PhD
principal investigator · UH Angers

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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