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治験 NCT06919029（対象：1型糖尿病）は募集中です。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
タイル表示
Effect of Advanced Hybrid Closed Loop System, MiniMed 780G in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study) 30 思春期 非盲検 観察研究 ハイブリッド
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 NCT06919029 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 募集中 で、2025年4月1日 から開始しています。30 名の参加者 の募集が計画されています。この試験は National and Kapodistrian University of Athens によって主導され、2026年4月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月9日 です。
概要
The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study,...もっと見る
公式タイトル
Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study): a Single Arm Open- Label Prospective Observational Study Protocol
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
- 6267/14.3.2025
NCT番号
開始日
2025-04
最終更新日
2025-04-09
終了予定日
2026-04
目標参加者数
30
試験の種類
観察研究
状況
募集中
キーワード
type 1 diabetes
advanced hybrid closed loop
diabetes onset
advanced hybrid closed loop
diabetes onset
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
該当なし | Advanced Hybrid Closed Loop from onset of type 1 diabetes in children The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study,...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
CGMS metrics | CGMS metrics including Time in Range (70-180 mg/dl) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study. | 3 and 6 months (extension phase) |
HbA1c | HbA1c | 3 months and 6 months (extension phase) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Acceptance of AHCL | Assess the percentage of the study participants willing to continue their therapy with AHCL as shown by prescribing the 780G insulin pump after the 3 months' time of their participation to the study. | 3 months |
TAR (Time Above Range) (>180mg/dl) | Time Above Range (\>180mg/dl) from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study. | 3 months and 6 months (extension phase) |
TBR (Time Below Range) (<70mg/dl) | TBR (Time Below Range) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study. | 3 and 6 months (extension phase) |
AHCL use | Advanced Hybrid Closed Loop use during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from AHCL data. The same metric will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study. | 3 and 6 months (extension phase) |
Total daily insulin requirements | Total daily insulin requirements during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study. | 3 and 6 months (extension phase) |
Hypoglycemia Fear Survey for Children and Parents (HFS-C & P) | QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of the questionnaire "Hypoglycemia Fear Survey for Children and Parents (HFS-C \& P)" | baseline, 3 months and 6 months (extension phase) |
PedsQL 3.0 Diabetes Module [Child (8-12 years of age) and Parent-Proxy Report for Children (ages 8-12), Adolescent (13-18 years of age), where appropriate | QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of questionnaire "PedsQL 3.0 Diabetes Module \[Child (8-12 years of age) and Parent-Proxy Report for Children (ages 8-12), Adolescent (13-18 years of age), where appropriate | baseline, 3 months and 6 months (extension phase) |
Brief Illness Perception Questionnaire | QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of questionnaire "Brief Illness Perception Questionnaire" | baseline, 3 months and 6 months (extension phase) |
Fasting c-peptide, ΒΜΙ-SDS from baseline to 3 and 6 months | Assess the change in fasting c-peptide from baseline to 3 and 6 months | baseline, 3 months and 6 months (extension phase) |
ΒΜΙ-SDS | Assess the change in ΒΜΙ-SDS from baseline to 3 and 6 months | baseline, 3 months and 6 months (extension phase) |
参加アシスタント
適格基準
対象年齢
小児
試験の最低年齢
7 Years
対象性別
全て
- Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetes is based on international criteria and the investigator's judgment; C peptide level and antibody determinations are not required.
- Age range 7 to 17 years.
- Literate in Greek or English.
- Willing to wear study devices.
- Willing to follow study-specific instructions.
- Total daily insulin dose greater than 8.0 units over 1 week period
- Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- Clinically eligible to start the AHCL system
- Type 2 diabetes mellitus or MODY diabetes
- Any untreated comorbidities of type 1 diabetes
- Medication affecting metabolic control or interfering in the interpretation of HbA1c
- Pregnancy
- Untreated diabetes retinopathy, or other causes that in the investigator's opinion, precludes the individual from participating in the trial.
- Known or suspected allergy to insulin.
- Regular use of acetaminophen.
- Lack of reliable telephone facility for contact.
- Living alone.
- Severe visual or hearing impairment.
- Medically documented allergy to the adhesive of plasters or unable to tolerate tape adhesive around sensor placement.
- Serious skin lesions at areas of the body used for insertion of the glucose sensor.
- Illicit drugs abuse.
- Alcohol abuse.
- Sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion or erythropoietin within 3 months prior to time of enrollment.
- Eating disorder including anorexia/bulimia.
- Milk protein allergy.
National and Kapodistrian University of AthensAghia Sophia Children's Hospital of Athens責任者
Christina Kanaka-Gantenbein, 主任研究者, Professor Pediatrics- Pediatric Endocrinology, Director First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
試験中央連絡先
連絡先: Christina Kanaka- Gantenbein, Professor, 00302132013244, [email protected]
1 1カ国の場所
First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital, Athens, 11527, Greece
Ioannis- Anargyros Vasilakis, PhD, 連絡先, 00302107467583, [email protected]
Christina Kanaka- Gantenbein, Professor, 主任研究者
Ioannis- Anargyros Vasilakis, PhD, 副研究者
Eleni Angelopoulou, 副研究者
Sophia Sakka, Asst. Prof., 副研究者
Alexandra Tsigkri, 副研究者
Ioanna Gkika, 副研究者
Ioanna Tokou, 副研究者
Vassia Chioti, 副研究者
Maria Michou, 副研究者
募集中