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

NCT07425912 | Completed

• 1 other identifier: 0024366/i
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes; Automated insulin delivery; Children and adolescents; Insulin pump; Continuous glucose monitoring; Hybrid closed-loop system; Real-world study; Artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Time in normal glucose range (TIR)

  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.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (10)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with type 1 diabetes receiving routine clinical care were recruited from specialized tertiary pediatric diabetes centers in Italy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Ospedale Meyer: collaborator
• University of Messina: collaborator

Study Sites (3)

Pediatric Diabetology Unit at the AOU "G. Martino"

Messina, Italy, Italy

Location

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

Naples, Italy, Italy

Location

Department of Diabetology and Endocrinology at the AOU Meyer IRCCS

Florence, Italy

Location

Related Publications (6)

• Amadou C, Melki V, Allain J, Clavel S, Gouet D, Chaillous L, Catargi B, Schaeplynck-Belicard P, Petit C, Thivolet C, Penfornis A. Performance and patients' satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study. PLoS One. 2023 Aug 24;18(8):e0289684. doi: 10.1371/journal.pone.0289684. eCollection 2023.

  PMID: 37616289 BACKGROUND

• Marks BE, Meighan S, Zehra A, Douvas JL, Rearson A, Suresh R, Brown EA, Wolf RM. Real-World Glycemic Outcomes with Early Omnipod 5 Use in Youth with Type 1 Diabetes. Diabetes Technol Ther. 2023 Nov;25(11):782-789. doi: 10.1089/dia.2023.0337. Epub 2023 Sep 20.

  PMID: 37646634 BACKGROUND

• Forlenza GP, DeSalvo DJ, Aleppo G, Wilmot EG, Berget C, Huyett LM, Hadjiyianni I, Mendez JJ, Conroy LR, Ly TT, Sherr JL. Real-World Evidence of Omnipod(R) 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technol Ther. 2024 Aug;26(8):514-525. doi: 10.1089/dia.2023.0578. Epub 2024 Feb 16.

  PMID: 38375861 BACKGROUND

• Kim JY, Jin SM, Kang ES, Kwak SH, Yang Y, Yoo JH, Bae JH, Moon JS, Jung CH, Bae JC, Suh S, Moon SJ, Song SO, Chon S, Kim JH. Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial. Diabetologia. 2024 Jul;67(7):1235-1244. doi: 10.1007/s00125-024-06155-y. Epub 2024 Apr 18.

  PMID: 38634887 BACKGROUND

• Asgharzadeh A, Patel M, Connock M, Damery S, Ghosh I, Jordan M, Freeman K, Brown A, Court R, Baldwin S, Ogunlayi F, Stinton C, Cummins E, Al-Khudairy L. Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling. Health Technol Assess. 2024 Dec;28(80):1-190. doi: 10.3310/JYPL3536.

  PMID: 39673446 BACKGROUND

• Hughes MS, Levy CJ. The Future of Automated Insulin Delivery Systems. Endocr Pract. 2025 Sep;31(9):1162-1170. doi: 10.1016/j.eprac.2025.05.752. Epub 2025 Jun 16.

  PMID: 40532759 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Angela Zanfardino, MD

  University of Campania "L.Vanvitelli"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor-PhD

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 23, 2026
• Study Start: September 5, 2025
• Primary Completion: March 5, 2026
• Study Completion: March 15, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)