NCT01013402 - 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)

Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL
Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987 Sep-Oct;10(5):622-8.
Clinical and Laboratory Standards Institute: Point-of-Care Glucose Testing in Acute and Chronic Care Facilities: Approved Guideline, 2nd ed
CLSI Document C30-A2. Wayne,PA: Clinical and Laboratory Standards Institute, 2002
Funk DL, Chan L, Lutz N, Verdile VP
Comparison of capillary and venous glucose measurements in healthy volunteers. Prehosp Emerg Care. 2001 Jul-Sep;5(3):275-7.
Trajanoski Z, Brunner GA, Gfrerer RJ, Wach P, Pieber TR
Accuracy of home blood glucose meters during hypoglycemia. Diabetes Care. 1996 Dec;19(12):1412-5.

Phase IV Study to Compare the Accuracy and Precission of Five Different Home Glucose Monitors;Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart

Details for clinical trial NCT01013402

Clinical trial NCT01013402 - References