Type 1 Diabetes MellitusNANO-KIDSNCT07425912
Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 76 participants
- Where
- 3 sitesItaly
- Study dates
- 5 Sep 2025to 15 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with type 1 diabetes receiving routine clinical care were recruited from specialized tertiary pediatric diabetes centers in Italy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Diabetology and Endocrinology at the AOU Meyer IRCCS
Florence
Pediatric Diabetology Unit at the AOU "G. Martino"
Messina, Italy
Centro Regionale di Diabetologia Pediatrica- AOU Univesità degli Studi della Campania "L.Vanvitelli"
Naples, Italy
About this study
Official 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
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.
Read the 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.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (10)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and at 1, 3, and 6 months
Mean sensor glucose
Average interstitial glucose concentration measured by continuous glucose monitoring during the assessment period.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From initiation of the A8 TouchCare® Nano system to 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start5 Sep 2025
- Primary completion5 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Meyer, University of Messina
- Responsible party
- Principal investigator, Angela Zanfardino,MD, University of Campania Luigi Vanvitelli
- Investigators
- Angela Zanfardino, MD, Principal investigator, University of Campania "L.Vanvitelli"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425912
- Sponsor's protocol ID
- 0024366/i
- Acronym
- NANO-KIDS
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37616289Marks 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.
PubMed 37646634Forlenza 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.
PubMed 38375861Kim 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.
PubMed 38634887Asgharzadeh 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.
PubMed 39673446Hughes 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.
PubMed 40532759Zanfardino A, Iafusco D, Ippolito G, Del Giudice EM, Rollato AS, Chianese A, Figuccia A, Toni S, Ferlito AG, Piccini B. Real-World Effectiveness and Safety of a Tubeless Automated Insulin Delivery System With an Adaptive Control Algorithm (APGO) in Children and Adolescents With Type 1 Diabetes: A Multicentre Observational Study. Diabetes Obes Metab. 2026 Jul 23. doi: 10.1111/dom.71101. Online ahead of print.
PubMed 42488981
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07425912
- Acronym / sponsor ID
- NANO-KIDS / 0024366/i
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Ospedale Meyer, University of Messina
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with type 1 diabetes receiving routine clinical care were recruited from specialized tertiary pediatric diabetes centers in Italy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Time below normale glucose range (TBR)
Time frame: 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
Glycated hemoglobin (HbA1c)
Time frame: 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
Time above glucose normal range (TAR)
Time frame: Baseline and at 1, 3, and 6 months
Mean sensor glucose
Time frame: 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 bolus insulin dose delivered by insulin pump
Time frame: Baseline, 1 month, 3 months, and 6 months
Body mass index (BMI)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 37616289Amadou 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.
- Background: PubMed 37646634Marks 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.
- Background: PubMed 38375861Forlenza 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.
- Background: PubMed 38634887Kim 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.
- Background: PubMed 39673446Asgharzadeh 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.
- Background: PubMed 40532759Hughes 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.
- Derived from this study: PubMed 42488981Zanfardino A, Iafusco D, Ippolito G, Del Giudice EM, Rollato AS, Chianese A, Figuccia A, Toni S, Ferlito AG, Piccini B. Real-World Effectiveness and Safety of a Tubeless Automated Insulin Delivery System With an Adaptive Control Algorithm (APGO) in Children and Adolescents With Type 1 Diabetes: A Multicentre Observational Study. Diabetes Obes Metab. 2026 Jul 23. doi: 10.1111/dom.71101. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Zanfardino, MD principal investigator
University of Campania "L.Vanvitelli"
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in normal glucose range (TIR) (time frame: Baseline, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425912, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.