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

March 9, 2024 updated by: Angela Zanfardino, University of Campania "Luigi Vanvitelli"

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Campania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
10 hours
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)
10 hours
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)
10 hours

Secondary Outcome Measures

Outcome Measure
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"
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)
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
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"
Time Frame: 10 hours
TAR (Time Above Range: amount of time those with diabetes spend with blood glucose levels >250 mg/dl)
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

February 7, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PZ_2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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