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.
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
76
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
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Time below normale glucose range (TBR)
TBR is the percentage of time during which glucose values measured by continuous glucose monitoring (CGM) are below 70 mg/dL
Time frame: Baseline, 1 month, 3 months, and 6 months
Total daily insulin dose delivered by insulin pump
Total amount of insulin administered per day, expressed in units per day (U/day), including both basal and bolus insulin delivery.
Time frame: Baseline, 1 month, 3 months, and 6 months
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) reflects the average blood glucose concentration over the preceding 8-12 weeks and is expressed as percentage (%) and mmol/mol.
Time frame: Baseline, 3 months, and 6 months
Number of severe low blood sugar events
Number of episodes of severe hypoglycaemia requiring assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Time frame: From initiation of the A8 TouchCare® Nano system to 6 months of follow-up
Time above glucose normal range (TAR)
TAR is the percentage of time during which glucose values measured by continuous glucose monitoring (CGM) exceed 180 mg/dL
Time frame: Baseline and at 1, 3, and 6 months
Mean sensor glucose
Average interstitial glucose concentration measured by continuous glucose monitoring during the assessment period.
Time frame: Baseline, 1 month, 3 and 6 months
Total daily basal insulin dose delivered by insulin pump
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.
Time frame: Baseline, 1 month, 3 months, 6 months
Total daily bolus insulin dose delivered by insulin pump
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
Time frame: Baseline, 1 month, 3 months, and 6 months
Body mass index (BMI)
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.
Time frame: Baseline, 3 months, 6 months
Number of diabetic ketoacidosis events
Number of episodes of diabetic ketoacidosis defined by hyperglycaemia associated with metabolic acidosis and requiring medical evaluation or hospitalization.
Time frame: From initiation of the A8 TouchCare® Nano system to 6 months of follow-up
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