Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes (NANO-KIDS)

University of Campania Luigi Vanvitelli

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT07425912

0024366/i

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 76 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

76 participants in 1 patient group

Children and adolescents with type 1 diabetes using the TouchCare Nano system

Description:

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.