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

April 21, 2026 updated by: Angela Zanfardino,MD, University of Campania Luigi Vanvitelli

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy
        • Department of Diabetology and Endocrinology at the AOU Meyer IRCCS
    • Italy
      • Messina, Italy, Italy
        • Pediatric Diabetology Unit at the AOU "G. Martino"
      • Naples, Italy, Italy
        • Centro Regionale di Diabetologia Pediatrica- AOU Univesità degli Studi della Campania "L.Vanvitelli"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in normal glucose range (TIR)
Time Frame: 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.
Baseline, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time below normale glucose range (TBR)
Time Frame: Baseline, 1 month, 3 months, and 6 months
TBR is the percentage of time during which glucose values measured by continuous glucose monitoring (CGM) are below 70 mg/dL
Baseline, 1 month, 3 months, and 6 months
Total daily insulin dose delivered by insulin pump
Time Frame: Baseline, 1 month, 3 months, and 6 months
Total amount of insulin administered per day, expressed in units per day (U/day), including both basal and bolus insulin delivery.
Baseline, 1 month, 3 months, and 6 months
Glycated hemoglobin (HbA1c)
Time Frame: Baseline, 3 months, and 6 months
Glycated hemoglobin (HbA1c) reflects the average blood glucose concentration over the preceding 8-12 weeks and is expressed as percentage (%) and mmol/mol.
Baseline, 3 months, and 6 months
Number of severe low blood sugar events
Time Frame: From initiation of the A8 TouchCare® Nano system to 6 months of follow-up
Number of episodes of severe hypoglycaemia requiring assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
From initiation of the A8 TouchCare® Nano system to 6 months of follow-up
Time above glucose normal range (TAR)
Time Frame: Baseline and at 1, 3, and 6 months
TAR is the percentage of time during which glucose values measured by continuous glucose monitoring (CGM) exceed 180 mg/dL
Baseline and at 1, 3, and 6 months
Mean sensor glucose
Time Frame: Baseline, 1 month, 3 and 6 months
Average interstitial glucose concentration measured by continuous glucose monitoring during the assessment period.
Baseline, 1 month, 3 and 6 months
Total daily basal insulin dose delivered by insulin pump
Time Frame: Baseline, 1 month, 3 months, 6 months
Total daily basal insulin dose delivered by insulin pump, defined as the cumulative background insulin administered through continuous subcutaneous insulin infusion over a 24-hour period (U/day), excluding bolus insulin.
Baseline, 1 month, 3 months, 6 months
Total daily bolus insulin dose delivered by insulin pump
Time Frame: Baseline, 1 month, 3 months, and 6 months
Total daily bolus insulin dose delivered by insulin pump, defined as the cumulative amount of corrective and meal-related insulin administered through continuous subcutaneous insulin infusion over a 24-hour period (U/day), excluding basal/background insulin
Baseline, 1 month, 3 months, and 6 months
Body mass index (BMI)
Time Frame: Baseline, 3 months, 6 months
Body mass index is calculated as weight in kilograms divided by height in meters squared (kg/m²) and reflects overall body weight relative to height.
Baseline, 3 months, 6 months
Number of diabetic ketoacidosis events
Time Frame: From initiation of the A8 TouchCare® Nano system to 6 months of follow-up
Number of episodes of diabetic ketoacidosis defined by hyperglycaemia associated with metabolic acidosis and requiring medical evaluation or hospitalization.
From initiation of the A8 TouchCare® Nano system to 6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Collaborators

University of Messina
Ospedale Meyer

Investigators

  • Principal Investigator: Angela Zanfardino, MD, University of Campania "L.Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Actual)

March 5, 2026

Study Completion (Actual)

March 15, 2026

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0024366/i

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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