Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05729776
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-01-27
Brief Title:
Evaluation of the Glucose Metrics After Eating Pizza Margherita in Hybrid Closed Loop Users
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 85 69 mmolmol 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 mgdl 5470mgdl 70140mgdl 70 180 180250 mgdl and 250 mgdl
Coefficient of variation
Average Sensor Glucose SD mgdl 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
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 mgdl 5470mgdl 70140mgdl 70 180 180250 mgdl and 250 mgdl
Coefficient of variation
Average Sensor Glucose SD mgdl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None