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

September 28, 2011 updated by: University Hospital, Angers

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bretagne
      • Brest, Bretagne, France, 29200
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • University Hospital of Toulouse
        • Contact:
    • Pays de Loire
      • Angers, Pays de Loire, France, 49933
        • University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Natacha Bouhours-Nouet, MD
        • Sub-Investigator:
          • Sylvie Dufresne, MD
        • Sub-Investigator:
          • Frédérique Gatelais, MD
      • Nantes, Pays de Loire, France, 44093
    • Rhône Alpes
      • Lyon, Rhône Alpes, France, 69000
        • University Hospital of Lyon
        • Contact:
    • Région Centre
      • Tours, Région Centre, France, 37000
        • University Hospital of Tours
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FIT Therapy
Patient with functional insulin therapy
Other: Therapeutic education
Specific program for FIT Therapy and specific program for traditional way
Other Names:
  • Functional insulin therapy
  • Traditional way (fixed doses of insulin)
Active Comparator: Traditional way
Patient with traditional way
Other: Therapeutic education
Specific program for FIT Therapy and specific program for traditional way
Other Names:
  • Functional insulin therapy
  • Traditional way (fixed doses of insulin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in HbA1c
Time Frame: One year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe hypoglycemia over 6 months and quality of life
Time Frame: One year and six months
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).
One year and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Régis Coutant, MD PhD, UH Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

September 30, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2009- 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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