NCT01443741 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Grimm JJ, Ybarra J, Berné 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.
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.
Langewitz W, Wössmer 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.
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.
Sämann A, Mühlhauser I, Bender R, Kloos Ch, Müller 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. Epub 2005 Aug 18.

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.

Details for clinical trial NCT01443741

Clinical trial NCT01443741 - References