NCT03748251

Management of Glycemia Following a Pizza Meal

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Glycemia following pizza consumption is typically managed with a dual wave insulin bolus. This study evaluated the effect of a simple bolus on glycemia following consumption of traditionally prepared pizzas with long (22 hours) or short (8 hours) dough fermentation periods.

Detailed description

All participants received pizza prepared in one of two ways, as described below, on two separate days. On the first day, they were given a pizza prepared with dough fermented for 8 hours (pizza A), and on the second study day they received a pizza prepared with dough fermented for 24 hours (pizza B). Participants and their parents were blinded to the type of pizza served on each day. Both meals were served at 7.00 pm at the pizzeria where the pizza had been prepared, and consumed within 30 minutes. Children and adolescents aged between 4 and 18 years with type 1 diabetes were eligible for inclusion in the study if they had received SIP therapy (MiniMed™ 640G, Medtronic, Tolochenaz, Switzerland) for at least 3 months One pizza of each type was prepared for chemical analysis

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	the patients ate a pizza that fermented for 8 hours	Patients eat pizza prepared with controlled ingredients but fermented 8 hours
OTHER	the patients ate a pizza that fermented for 24 hours	Patients eat pizza prepared with controlled ingredients but fermented 24 hours

Timeline

• Start date: 2018-02-14
• Primary completion: 2018-03-21
• Completion: 2018-10-01
• First posted: 2018-11-20
• Last updated: 2018-11-20

Locations

1 site across 1 country: Italy