Type1diabetesNCT05729776
Evaluation of the Glucose Metrics After Eating Pizza Margherita in Hybrid Closed Loop Users
An observational study of Type1diabetes, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type1diabetes
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 7 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- The patients aged between 8- 18 will be included in the study just in a condition of using HCL Systems at least 3 months
Who cannot join
- Patients with HbA1c >8.5 % (69 mmol/mol), celiac disease, other food allergies will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Glucose Metrics After Eating Pizza Margherita and a Meal Equivalent in Macronutrient in Pediatric Patients With Type 1 Diabetes Mellitus Treated With Hybrid Closed Loop Systems
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.
Read the detailed description
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:
- Percentage of time in targets with sensor glucose (SG) cut-offs of <54 mg/dl, ≤54>70mg/dl, ≥70<140mg/dl, ≥70 <180; ≥180<250 mg/dl and ≥250 mg/dl
- Coefficient of variation (%)
- Average Sensor Glucose SD (mg/dl) Times in target will be evaluated over the entire observation period (10 hours after bolus), from the bolus administration to 2 hours after administration, and from 2 to 5 hours after administration.
Data about insulin dose:
Endpoints from insulin pump will be evaluated:
- Total insulin dose (IU): it will be calculated as the sum of total basal insulin (IU) and total bolus insulin (IU) infused during the entire observation period.
- Total bolus amount (IU and %)
- Autocorrection bolus amount (IU and %)
- Autobasal amount (IU and %)
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:
- "Pizza consumption" vs "control meal";
- "Medtronic pizza management" vs "Tandem T slim pizza management"
- Conditions
- Type1diabetes
- Keywords
- Glucose metrics, Pizza, Hybrid closed loop systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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"
TIR (Time in range:amount of time those with diabetes spend with blood glucose levels between 70 and 180 mg/dl)
Measured: 10 hours
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management"
TBR (Time below range:amount of time those with diabetes spend with blood glucose levels < 70 mg/dl)
Measured: 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)
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Dec 2022
- Primary completion27 Jan 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Zanfardino, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729776
- Sponsor's protocol ID
- PZ_2022
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31335171Della-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.
PubMed 32240944De 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.
PubMed 21355715Zanfardino 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.
PubMed 40170658
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Glucose Metrics After Eating Pizza Margherita and a Meal Equivalent in Macronutrient in Pediatric Patients With Type 1 Diabetes Mellitus Treated With Hybrid Closed Loop Systems
- ClinicalTrials.gov ID
- NCT05729776
- Acronym / sponsor ID
- PZ_2022
- Conditions
- Type1diabetes
- Keywords
- Glucose metrics, Pizza, Hybrid closed loop systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Percentage of time in targets with sensor glucose (SG) cut-offs of <54 mg/dl, ≤54>70mg/dl, ≥70<140mg/dl, ≥70 <180; ≥180<250 mg/dl and ≥250 mg/dl
- Coefficient of variation (%)
- Average Sensor Glucose SD (mg/dl) Times in target will be evaluated over the entire observation period (10 hours after bolus), from the bolus administration to 2 hours after administration, and from 2 to 5 hours after administration.
Data about insulin dose:
Endpoints from insulin pump will be evaluated:
- Total insulin dose (IU): it will be calculated as the sum of total basal insulin (IU) and total bolus insulin (IU) infused during the entire observation period.
- Total bolus amount (IU and %)
- Autocorrection bolus amount (IU and %)
- Autobasal amount (IU and %)
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:
- "Pizza consumption" vs "control meal";
- "Medtronic pizza management" vs "Tandem T slim pizza management"
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- The patients aged between 8- 18 will be included in the study just in a condition of using HCL Systems at least 3 months
Key exclusion criteria (1 listed)
- Patients with HbA1c >8.5 % (69 mmol/mol), celiac disease, other food allergies will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal
Time frame: 10 hours
TIR (Time in range:amount of time those with diabetes spend with blood glucose levels between 70 and 180 mg/dl)
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal
Time frame: 10 hours
TBR (Time below range:amount of time those with diabetes spend with blood glucose levels < 70 mg/dl)
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal
Time frame: 10 hours
TAR (Time Above Range: amount of time those with diabetes spend with blood glucose levels >250 mg/dl)
3 secondary outcomes
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) in "Medtronic pizza management" and in "Tandem T slim pizza management"
Time frame: 10 hours
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management"
Time frame: 10 hours
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after "Medtronic pizza management" and"Tandem T slim pizza management"
Time frame: 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 31335171Zanfardino 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.
- Results publication: PubMed 32240944Della-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.
- Results publication: PubMed 21355715De 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.
- Derived from this study: PubMed 40170658Zanfardino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal (time frame: 10 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729776, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.