Real-World Efficacy and Safety of the TouchCare Nano Automated Insulin Delivery System With APGO Algorithm in Children and Adolescents With Type 1 Diabetes: A Multicentre Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Time in normal glucose range (TIR)
研究概览
简要总结
The goal of this observational study is to learn how well the TouchCare Nano automated insulin delivery system works and how safe it is for children and adolescents with type 1 diabetes in everyday medical care.
The main questions this study aims to answer are:
Does using the TouchCare Nano system help people with type 1 diabetes spend more time with their blood glucose in a healthy range? Are serious low blood sugar events or diabetic ketoacidosis uncommon while using this system in daily life? Participants are children and adolescents with type 1 diabetes who use the TouchCare Nano system as part of their regular diabetes care. Researchers will collect glucose sensor data and routine clinical information at the start of the study and during follow-up visits over about six months.
详细描述
This multicentre, prospective, real-world observational study is designed to evaluate the efficacy and safety of the TouchCare Nano automated insulin delivery (AID) system with APGO™ algorithm in children and adolescents with type 1 diabetes. The study is conducted in routine clinical practice at three specialized pediatric diabetes centers in Italy.
Participants aged 6 to 18 years with a diagnosis of type 1 diabetes and a minimum disease duration of six months are included after clinical indication for insulin pump therapy. All participants transition to the TouchCare Nano system as part of standard care, without any study-driven modification of treatment.
The TouchCare Nano system is a tubeless patch pump integrated with a continuous glucose monitoring (CGM) system and an adaptive control algorithm (APGO™) based on artificial intelligence principles, designed to optimize insulin delivery in a hybrid closed-loop mode.
Clinical and CGM-derived outcomes are collected at baseline and at 1, 3, and 6 months following the transition to automated insulin delivery. The primary outcome is Time in Range (TIR, 70-180 mg/dL). Secondary outcomes include additional CGM metrics, insulin delivery parameters, and clinical variables such as HbA1c and body mass index z-score.
Safety is evaluated by monitoring the incidence of severe hypoglycemia and diabetic ketoacidosis throughout the 6-month follow-up period. The study has received approval from the relevant Ethics Committee, and written informed consent is obtained from all participants and their parents or legal guardians prior to data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 18 years
- •Diagnosis of type 1 diabetes mellitus for ≥6 months
- •Treatment with insulin therapy (multiple daily injections or continuous subcutaneous insulin infusion) for ≥6 months prior to enrolment
- •Clinical indication for transition to insulin pump therapy according to routine diabetes care
- •Ability of participant and family to understand and comply with study procedures
- •Written informed consent from parent(s) or legal guardian(s), and assent from the participant when applicable
排除标准
- •Diabetic ketoacidosis within the 3 months before enrollment
- •Use of medications known to affect blood glucose levels
- •Body weight less than 20 kilograms
- •Total daily insulin dose less than 10 international units
研究组 & 干预措施
Children and adolescents with type 1 diabetes using the TouchCare Nano system
This cohort includes children and adolescents aged 6 to 18 years with type 1 diabetes who use the TouchCare Nano automated insulin delivery system as part of their regular diabetes care. All participants are followed over time to collect glucose sensor data and routine clinical information during a 6-month follow-up period.
结局指标
主要结局
Time in normal glucose range (TIR)
时间窗: Baseline, 1 month, 3 months, and 6 months
Time in Range (TIR) is the percentage of time that glucose levels are between 70 and 180 milligrams per deciliter, measured using continuous glucose monitoring data.
次要结局
- Time below normale glucose range (TBR)(Baseline, 1 month, 3 months, and 6 months)
- Total daily insulin dose delivered by insulin pump(Baseline, 1 month, 3 months, and 6 months)
- Glycated hemoglobin (HbA1c)(Baseline, 3 months, and 6 months)
- Number of severe low blood sugar events(From initiation of the A8 TouchCare® Nano system to 6 months of follow-up)
- Time above glucose normal range (TAR)(Baseline and at 1, 3, and 6 months)
- Mean sensor glucose(Baseline, 1 month, 3 and 6 months)
- Total daily basal insulin dose delivered by insulin pump(Baseline, 1 month, 3 months, 6 months)
- Total daily bolus insulin dose delivered by insulin pump(Baseline, 1 month, 3 months, and 6 months)
- Body mass index (BMI)(Baseline, 3 months, 6 months)
- Number of diabetic ketoacidosis events(From initiation of the A8 TouchCare® Nano system to 6 months of follow-up)
研究者
Angela Zanfardino,MD
Medical Doctor-PhD
University of Campania Luigi Vanvitelli