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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03748251
Enrollment
38
Registered
2018-11-20
Start date
2018-02-14
Completion date
2018-10-01
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Subcutaneous Insulin Infusion, diet, postprandial glucose, postprandial hypoglycemia, postprandial hyperglycemia

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

Interventions

OTHERthe patients ate a pizza that fermented for 8 hours

Patients eat pizza prepared with controlled ingredients but fermented 8 hours

OTHERthe patients ate a pizza that fermented for 24 hours

Patients eat pizza prepared with controlled ingredients but fermented 24 hours

Sponsors

Federico II University
CollaboratorOTHER
University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Continuous glucose sensor data11 hoursmmol/L

Secondary

MeasureTime frameDescription
Content of carbohydrates1 hourµg/g

Other

MeasureTime frameDescription
Content of amino acids1 hourµg/g

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026