Evaluation of the Glucose Metrics After Eating Pizza Margherita in Hybrid Closed Loop Users

NCT05729776 | Completed

• 1 other identifier: PZ_2022
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type1diabetes

Keywords

Glucose metrics; Pizza; Hybrid closed loop systems

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) in "Medtronic pizza management" and in "Tandem T slim pizza management"

  10 hours

• TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management"

  10 hours

• TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management"

  10 hours

Study Arms (4)

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

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• The patients aged between 8- 18 will be included in the study just in a condition of using HCL Systems at least 3 months

You may not qualify if:

• Patients with HbA1c \>8.5 % (69 mmol/mol), celiac disease, other food allergies will be excluded.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania

Naples, 80100, Italy

Location

Related Publications (4)

• 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.

  PMID: 31335171 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.

  PMID: 32240944 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.

  PMID: 21355715 RESULT

• 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.

  PMID: 40170658 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 15, 2023
• Study Start: December 1, 2022
• Primary Completion: January 27, 2023
• Study Completion: February 7, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

IT (1)