NCT07425912Completed
Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 76 (actual)
- First submitted
- 7 Feb 2026
- Start date
- 5 Sept 2025
- Primary completion date
- 5 Mar 2026
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Type 1 diabetes
- NCT number
- NCT07425912
What you commit to
- Study type: Observational
- Participants enrolled: 76
- From 5 Sept 2025 to the primary completion date, 5 Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diabetic ketoacidosis within the 3 months before enrollment
Lab values
- Use of medications known to affect blood glucose levels
Other
- Body weight less than 20 kilograms
- Total daily insulin dose less than 10 international units
Who the study is looking for
- 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
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Diabetology and Endocrinology at the AOU Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Pediatric Diabetology Unit at the AOU "G. Martino" Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| Centro Regionale di Diabetologia Pediatrica- AOU Univesità degli Studi della Campania "L.Vanvitelli" Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.