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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients aged between 8- 18 will be included in the study just in a condition of using HCL Systems at least 3 months
排除标准
- •Patients with HbA1c >8.5 % (69 mmol/mol), celiac disease, other food allergies will be excluded.
结局指标
主要结局
TIR, TBR and TAR evaluation(glucose metrics by glucose sensor) after the consumption of pizza meal vs control meal
时间窗: 10 hours
TAR (Time Above Range: amount of time those with diabetes spend with blood glucose levels \>250 mg/dl)
次要结局
- 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) in "Medtronic pizza management" and in "Tandem T slim pizza management"(10 hours)
研究者
Angela Zanfardino
medical doctor
University of Campania "Luigi Vanvitelli"