NCT03748251 - 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)

Ahern JA, Gatcomb PM, Held NA, Petit WA Jr, Tamborlane WV
Exaggerated hyperglycemia after a pizza meal in well-controlled diabetes. Diabetes Care. 1993 Apr;16(4):578-80.
Combet E, Jarlot A, Aidoo KE, Lean ME
Development of a nutritionally balanced pizza as a functional meal designed to meet published dietary guidelines. Public Health Nutr. 2014 Nov;17(11):2577-86. doi: 10.1017/S1368980013002814. Epub 2013 Oct 28.
De Palma A, Giani E, Iafusco D, Bosetti A, Macedoni M, Gazzarri A, Spiri D, Scaramuzza AE, Zuccotti GV
Lowering postprandial glycemia in children with type 1 diabetes after Italian pizza "margherita" (TyBoDi2 Study). Diabetes Technol Ther. 2011 Apr;13(4)
Gallus S, Tavani A, La Vecchia C
Pizza and risk of acute myocardial infarction. Eur J Clin Nutr. 2004 Nov;58(11):1543-6.
Jones SM, Quarry JL, Caldwell-McMillan M, Mauger DT, Gabbay RA
Optimal insulin pump dosing and postprandial glycemia following a pizza meal using the continuous glucose monitoring system. Diabetes Technol Ther. 2005 Apr;7(2):233-40.
Mauseth R, Lord SM, Hirsch IB, Kircher RC, Matheson DP, Greenbaum CJ
Stress Testing of an Artificial Pancreas System With Pizza and Exercise Leads to Improvements in the System's Fuzzy Logic Controller. J Diabetes Sci Technol. 2015 Sep 14;9(6):1253-9. do
Pankowska E, Blazik M, Groele L
Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study. Diabetes Technol Ther. 2012 Jan;14(1):16-22. doi: 10.1089/dia.2011.0083. Epub

Demystifying the Pizza Bolus: the Effect of Dough Fermentation Time on Glycemic Response in Children With Type 1 Diabetes Mellitus Receiving Sensor-augmented Pump Therapy

Details for clinical trial NCT03748251

Clinical trial NCT03748251 - References