NCT00829062 - 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)

Boland EA, Grey M, Oesterle A, Fredrickson L, Tamborlane WV
Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with type 1 diabetes. Diabetes Care. 1999 Nov;22(11):1779-84.
Ramchandani N, Ten S, Anhalt H, Sinha S, Ching J, Finkelstein A, Maclaren NK
Insulin pump therapy from the time of diagnosis of type 1 diabetes. Diabetes Technol Ther. 2006 Dec;8(6):663-70.
Shalitin S, Phillip M
The role of new technologies in treating children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2007 Oct;8 Suppl 6:72-9. Review.
Weinzimer SA, Ahern JH, Doyle EA, Vincent MR, Dziura J, Steffen AT, Tamborlane WV
Persistence of benefits of continuous subcutaneous insulin infusion in very young children with type 1 diabetes: a follow-up report. Pediatrics. 2004 Dec;114(6):1601-5. Erratum in: Pediatrics. 2005 Feb;115(2):518.

Presenting Evidence Based Practice to an Insurance Provider to Expand Coverage of Continuous Subcutaneous Insulin Infusion (CSII) in Pediatric Patients With Diabetes

Details for clinical trial NCT00829062

Clinical trial NCT00829062 - References