NCT01158040 - 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)

Carron Brown S, Kyne-Grzebalski D, Mwangi B, Taylor R
Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice. Diabet Med. 1999 Jul;16(7):573-8.
Jovanovic L
Glucose and insulin requirements during labor and delivery: the case for normoglycemia in pregnancies complicated by diabetes. Endocr Pract. 2004 Mar-Apr;10 Suppl 2:40-5. Review.
Lepercq J, Abbou H, Agostini C, Toubas F, Francoual C, Velho G, Dubois-Laforgue D, Timsit J
A standardized protocol to achieve normoglycaemia during labour and delivery in women with type 1 diabetes. Diabetes Metab. 2008 Feb;34(1):33-7.
Taylor R, Lee C, Kyne-Grzebalski D, Marshall SM, Davison JM
Clinical outcomes of pregnancy in women with type 1 diabetes(1). Obstet Gynecol. 2002 Apr;99(4):537-41.

Intrapartum Maternal Glycemic Control Using Insulin Pump Versus Insulin Drip Cohort Retrospective and Prospective Observational Trial

Clinical trial NCT01158040 - References