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In previous study the investigators proved that blood glucose after eating pizza margherita could be managed with a simple wave bolus of insulin in pediatric patients with type 1 diabetes under controlled conditions. Participants in this previous study were Predictive Low Glucose Suspended (PLGS) System users. In this study the investigators want to demonstrate that blood glucose after the meal pizza margherita could also be managed with simple wave bolus of insulin in real life. The investigators will include just the patients with Hybrid Closed Loop (HCL) System.
The investigators will enroll all patients with type 1 diabetes using of Hybrid Closed Loop (HCL) Systems (Medtronic MiniMed 780 G insulin pump system, Tandem T: Slim X2 insulin pump) followed in a diabetes center. The patients aged between 8- 18 will be included in the study just in a condition of using HCL Systems at least 3 months. Patients with HbA1c >8.5 % (69 mmol/mol), celiac disease, other food allergies will be excluded. The investigators will ask to parents feeding children with a pizza margherita which contains 100 grams of carbohydrates. Even if the patients could choose to consume pizza in different restaurants, the investigators will suggest having the pizza prepared with 200 grams of dough (which contains about 100 grams of carbohydrate). To validate the results the investigators will compare, for each patient, the data of glucose sensor and insulin pump after pizza consumption with those resulting from the consumption of a meal with the same macronutrient content. Patients should not consume anything else for 12 hours after the pizza (and after the meal containing the same macronutrient content). For this reason, patients will be encouraged to have these meals for dinner.
The aim of the study is comparing pizza with another meal which contains similar macronutrients. Second goal of this study is evaluating the blood glucose profile after eating pizza comparing the competency of two different Hybrid Closed Loop (HCL) Systems (Medtronic MiniMed 780 G insulin pump system, Tandem T: Slim X2 insulin pump) to manage blood glucose after eating pizza.
The investigators will collect data from both Carelink (for Medtronic device) and from Diasend (from Tandem device). All data will be exported in an excel file.
Demographic and clinical characteristic of enrolled patients (sex, BMI, Zscore BMI), HbA1c) will be collected from their medical records.
Observation period: from the dinner bolus to the next 10 hours of fasting.
Data from glucose sensor:
Endpoints from the sensor data will be evaluated:
Data about insulin dose:
Endpoints from insulin pump will be evaluated:
Data about carbohydrates amount:
Total carbohydrates amount entered during the observation period
Data about automatic mode:
Percentage of time in AutoMode during the observation period
The investigators will compare data of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall eating pizza | All the patients that ate pizza | ||
| Overall eating control meal | All patients that ate control mail (bread) | ||
| Tandem patients eating pizza | All patients that ate pizza using Tandem Tslim system | ||
| Medtronic 780 patients eating pizza | All patients that ate pizza using Medtronic 780 System |
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| Measure | Description | Time Frame |
|---|---|---|
| TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal | TIR (Time in range:amount of time those with diabetes spend with blood glucose levels between 70 and 180 mg/dl) | 10 hours |
| TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal | TBR (Time below range:amount of time those with diabetes spend with blood glucose levels < 70 mg/dl) | 10 hours |
| TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal | TAR (Time Above Range: amount of time those with diabetes spend with blood glucose levels >250 mg/dl) | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) in "Medtronic pizza management" and in "Tandem T slim pizza management" | TIR (Time in range:amount of time those with diabetes spend with blood glucose levels between 70 and 180 mg/dl) | 10 hours |
| TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management" |
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Inclusion Criteria:
Exclusion Criteria:
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We will enroll all patients with type 1 diabetes using of Hybrid Closed Loop (HCL) Systems (Medtronic MiniMed 780 G insulin pump system, Tandem T: Slim X2 insulin pump) followed in our diabetes center.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campania | Naples | 80100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31335171 | Result | 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. | |
| 32240944 |
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TBR (Time below range:amount of time those with diabetes spend with blood glucose levels < 70 mg/dl) |
| 10 hours |
| TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management" | TAR (Time Above Range: amount of time those with diabetes spend with blood glucose levels >250 mg/dl) | 10 hours |
| Result |
| Della-Corte T, Gentile S, Di Blasi V, Guarino G, Corigliano M, Cozzolino G, Fasolino A, Martino C, Improta MR, Oliva D, Lamberti C, Vecchiato A, Vaia S, Satta E, Romano C, Alfarone C, Strollo F; Nefrocenter & Nyx Start-Up Research Study Group. Is pizza sutable to type 1 diabetes? A real life identification of best compromise between taste and low glycemic index in patients on insulin pump. Diabetes Metab Syndr. 2020 May-Jun;14(3):225-227. doi: 10.1016/j.dsx.2020.03.003. Epub 2020 Mar 12. |
| 21355715 | Result | 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):483-7. doi: 10.1089/dia.2010.0163. Epub 2011 Feb 28. |
| 40170658 | Derived | Zanfardino A, Ippolito G, Ozen G, Galderisi A, Rollato AS, Chianese A, Testa V, Miraglia Del Giudice E, Scaramuzza AE, Iafusco D. Real-Life Performance of Automated Insulin Delivery Systems for High-Carbohydrate Meals: Are All Systems the Same? Diabetes Technol Ther. 2025 Aug;27(8):669-673. doi: 10.1089/dia.2025.0106. Epub 2025 Apr 2. |