Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes, Automated insulin delivery, Children and adolescents, Insulin pump, Continuous glucose monitoring, Hybrid closed-loop system, Real-world study, Artificial pancreas
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.
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.
Interventions
None listed
Sponsors
University of Campania Luigi Vanvitelli
Ospedale Meyer
University of Messina
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in normal glucose range (TIR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time below normale glucose range (TBR) | 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 |
| Total daily insulin dose delivered by insulin pump | 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. |
| Glycated hemoglobin (HbA1c) | 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. |
| Number of severe low blood sugar events | 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. |
| Time above glucose normal range (TAR) | 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 |
| Mean sensor glucose | Baseline, 1 month, 3 and 6 months | Average interstitial glucose concentration measured by continuous glucose monitoring during the assessment period. |
| Total daily basal insulin dose delivered by insulin pump | 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. |
| Total daily bolus insulin dose delivered by insulin pump | 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 |
| Body mass index (BMI) | 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. |
| Number of diabetic ketoacidosis events | 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. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORAngela Zanfardino, MD
University of Campania "L.Vanvitelli"
Outcome results
None listed