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治験 NCT07425912 (NANO-KIDS)（対象：1型糖尿病）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes (NANO-KIDS) 76 RWE 小児 思春期 観察研究
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07425912 (NANO-KIDS) は 観察研究 臨床試験 で、1型糖尿病 に関するものです。現在は 実施中／登録終了 で、2025年9月5日 から開始しています。76 名の参加者 の募集が計画されています。この試験は University of Campania Luigi Vanvitelli によって主導され、2026年3月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月23日 です。
概要
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 sug...
もっと見る詳細説明
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 diabete...
もっと見る公式タイトル
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
疾患名
1型糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- NANO-KIDS
- 0024366/i
NCT番号
開始日
2025-09-05
最終更新日
2026-02-23
終了予定日
2026-03-15
目標参加者数
76
試験の種類
観察研究
状況
実施中／登録終了
キーワード
Type 1 diabetes
Automated insulin delivery
Children and adolescents
Insulin pump
Continuous glucose monitoring
Hybrid closed-loop system
Real-world study
Artificial pancreas
Automated insulin delivery
Children and adolescents
Insulin pump
Continuous glucose monitoring
Hybrid closed-loop system
Real-world study
Artificial pancreas
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
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. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | Baseline, 1 month, 3 months, and 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 | 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. | 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. | 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. | 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 | Baseline and at 1, 3, and 6 months |
Mean sensor glucose | 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 | 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 | 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) | 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 | 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 |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
6 Years
対象性別
全て
- 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
- 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
University of Campania Luigi Vanvitelli- Ospedale Meyer
- University of Messina
責任者
Angela Zanfardino, 主任研究者, Medical Doctor-PhD, University of Campania Luigi Vanvitelli
連絡先情報がありません。
3 1カ国の場所
Italy
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