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Completed

NCT Number: NCT07425912

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Diabetology Unit at the AOU "G. Martino", Messina, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Collaborators

  • Ospedale Meyer
  • University of Messina

Registry information

Official study 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

Acronym: NANO-KIDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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