Clinical trial NCT03748251: Management of Glycemia Following a Pizza Meal
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Continuous Subcutaneous Insulin Infusion
diet
postprandial glucose
postprandial hypoglycemia
postprandial hyperglycemia
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2018-11-20
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes if they had received sensor integrated pump (SIP) therapy for at least 3 months

Exclusion Criteria:

* Patients with HbA1c \>8.5% (69 mmol/mol), celiac disease, other food allergies or concurrent illness

Primary outcomes:
measure: Continuous glucose sensor data
timeFrame: 11 hours
Secondary outcomes:
measure: Content of carbohydrates
timeFrame: 1 hour
Other outcomes:
measure: Content of amino acids
timeFrame: 1 hour
Locations:
city: Naples
country: Italy
facility: Centro di Diabetologia Pediatrica "G.Stoppoloni"
Study officials:
References:
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citation: Zanfardino A, Confetto S, Curto S, Cocca A, Rollato AS, Zanfardino F, Troise AD, Testa V, Bologna O, Stanco M, Piscopo A, Cohen O, Miraglia Del Giudice E, Vitaglione P, Iafusco D. Demystifying the Pizza Bolus: The Effect of Dough Fermentation on Glycemic Response-A Sensor-Augmented Pump Intervention Trial in Children with Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2019 Dec;21(12):721-726. doi: 10.1089/dia.2019.0191. Epub 2019 Aug 8.