Diabetes Insulin DependentPhase 2DIABFITNCT01443741
Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent
A Phase 2 study testing Therapeutic education in people with Diabetes Insulin Dependent, run by University Hospital, Angers at 6 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Diabetes Insulin Dependent
- What is being tested?
- Therapeutic education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2012to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
University Hospital of Angers Service of Pediatric Diabetology and Endocrinology
Angers, Pays de Loire, 49933
Regis Coutant, MD-PhD, 33(0)2-41-35-56-55, ReCoutant@chu-angers.fr
Natacha Bouhours-Nouet, MD, 33(0)2-41-35-44-06, NaBouhours-Nouet@chu-angers.fr
University Hospital of Brest
Brest, Brittany Region, 29200
Chantal Metz, MD, (0)2 98 22 33 88 ext. 33, chantal.metz@chu-brest.fr
University Hospital of Lyon
Lyon, Auvergne-Rhône-Alpes, 69000
Marc Nicolino, MD-PhD, (0)4 72 38 58 73 ext. 33, marc.nicolino@chu-lyon.fr
University Hospital of Nantes
Nantes, Pays de Loire, 44093
Sabine Baron, MD, (0)2 40 08 33 33 ext. 33, sabine.baron@chu-nantes.fr
University Hospital of Toulouse
Toulouse, Midi-Pyrénées, 31059
Claire Le Tallec, MD, (0)5 34 55 85 64 ext. 33, letallec.c@chu-toulouse.fr
University Hospital of Tours
Tours, Centre-Val de Loire, 37000
Myriam Pépin-Donat, MD, (0)2 47 47 38 68 ext. 33, m.pepin-donat@chu-tours.fr
About this study
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.
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.
- Conditions
- Diabetes Insulin Dependent
- Being tested
- Therapeutic education
- Keywords
- FIT Therapy, Diabetes mellitus, Insulin pump, Pediatric
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationOther
Also called Functional insulin therapy, Traditional way (fixed doses of insulin)
Specific program for FIT Therapy and specific program for traditional way
| Study group | Role | What they receive |
|---|---|---|
| FIT Therapy | Active comparator | Patient with functional insulin therapy Receives: Other: Therapeutic education |
| Traditional way | Active comparator | Patient with traditional way Receives: Other: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: One year and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Insulin DependentStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Régis Coutant, MD PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443741
- Sponsor's protocol ID
- PHRC 2009- 03
- Acronym
- DIABFIT
- Status last verified
- Sep 2011
- First submitted
- 28 Sep 2011
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
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 9306036Hartemann-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 12629448Samann 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 16132954Lowe 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 18353485Grimm 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01443741
- Acronym / sponsor ID
- DIABFIT / PHRC 2009- 03
- Conditions
- Diabetes Insulin Dependent
- Keywords
- FIT Therapy, Diabetes mellitus, Insulin pump, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT Therapy | Active comparator | Other: Therapeutic educationPatient with functional insulin therapy |
| Traditional way | Active comparator | Other: Therapeutic educationPatient with traditional way |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Ages <1 year or> 17 years
- Duration of diabetes <1 year
- HbA1c <7.6% or HbA1c> 10%
- Treatment-by multiple injections
- Mental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic educationAlso: Functional insulin therapy, Traditional way (fixed doses of insulin)Specific program for FIT Therapy and specific program for traditional way | Other | FIT Therapy, Traditional way |
Primary outcome
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.
1 secondary outcome
Severe hypoglycemia over 6 months and quality of life
Time frame: One year and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
- Background: PubMed 9306036Langewitz 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.
- Background: PubMed 12629448Hartemann-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.
- Background: PubMed 16132954Samann 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.
- Background: PubMed 18353485Lowe 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.
- Background: PubMed 15671916Grimm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Régis Coutant, MD PhD principal investigator
UH Angers
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Therapeutic education in people with Diabetes Insulin Dependent, run by University Hospital, Angers at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Régis Coutant, MD PhD (33(2)41-35-56-55, ReCoutant@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in HbA1c (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443741, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2011.