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ACTIVE NOT RECRUITING
NCT07425912

Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes

Sponsor: University of Campania Luigi Vanvitelli

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

76

Start Date

2025-09-05

Completion Date

2026-03-15

Last Updated

2026-02-23

Healthy Volunteers

No

Locations (3)

Pediatric Diabetology Unit at the AOU "G. Martino"

Messina, Italy, Italy

Centro Regionale di Diabetologia Pediatrica- AOU Univesità degli Studi della Campania "L.Vanvitelli"

Naples, Italy, Italy

Department of Diabetology and Endocrinology at the AOU Meyer IRCCS

Florence, Italy