Management of Glycemia Following a Pizza Meal

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: the patients ate a pizza that fermented for 8 hours
* Other: the patients ate a pizza that fermented for 24 hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short fermented pizza<br>the patients ate a pizza that fermented for 8 hours | Other: the patients ate a pizza that fermented for 8 hours<br>* Patients eat pizza prepared with controlled ingredients but fermented 8 hours<br>|
| Experimental: Long fermented pizza<br>the patients ate a pizza that fermented for 24 hours | Other: the patients ate a pizza that fermented for 24 hours<br>* Patients eat pizza prepared with controlled ingredients but fermented 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous glucose sensor data | mmol/L | 11 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Content of carbohydrates | µg/g | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Subcutaneous Insulin Infusion, diet, postprandial glucose, postprandial hypoglycemia, postprandial hyperglycemia