治験レーダーAI | ||
|---|---|---|
治験 NCT06516640（対象：2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
Type 2 Continuous Glucose Monitoring Academy 60 バーチャル
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 NCT06516640 は 介入研究 臨床試験 で、2型糖尿病 に関するものです。現在は 募集中 で、2025年6月23日 から開始しています。60 名の参加者 の募集が計画されています。この試験は Children's Hospital Los Angeles によって主導され、2026年12月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月6日 です。
概要
The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):
- The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies.
- The second aim is to evaluate the effects of the ...
公式タイトル
Randomized Control Trial Evaluating the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes
疾患名
2型糖尿病その他の研究識別子
- CHLA-24-00199
- P50MD017344 (米国NIHの助成金/契約)
NCT番号
開始日
2025-06-23
最終更新日
2026-02-06
終了予定日
2026-12-30
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Continuous Glucose Monitoring
Glycemic Control
Diabetes Education
Type 2 Diabetes
Glycemic Control
Diabetes Education
Type 2 Diabetes
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
プラセボ対照薬Control Receives standard of care, regular education in the clinic. | 標準教育 Standard of care receives general education about diabetes. |
実験的Continuous Glucose Monitoring Academy Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). Participate in four in-depth online group sessions with diabetes care and education specialists complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. | Continuous Glucose Monitoring Academy Educational materials as well as online sessions with diabetes educators. 標準教育 Standard of care receives general education about diabetes. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean change in Time in Range (TIR) from baseline to 6 months | Change in % glucose TIR (70-180 mg/dL) | Baseline to 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months | Change in Hemoglobin A1c | Baseline to 6 months |
Mean change in CGM metrics measured by CGM readings | % Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL), % Glucose Variability (coefficient of variation, CV) | Week 4 & 6 months |
Change in perceived diabetes distress at baseline, week 4 & 6 months | The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall emotional distress is due to diabetes. Respondents are given statements about diabetes-related issues and indicate on a 5-point Likert scale (0 = not a problem, 1 = minor problem, 2 = moderate problem, 3 = somewhat serious problem, 4 = serious problem) the degree to which the statements are a problem. Increasing scores denote increased burden perceived. | Baseline, Week 4 & 6 months |
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months | The Diabetes Family Responsibility Questionnaire (DFRQ) is a 14-item validated survey assessing parental and child involvement in various diabetes management tasks. Youth and caregivers report on a 3-point scale (1=child, 2=equal, 3=parent) who is responsible for a given diabetes task. Higher scores indicate more parental involvement in diabetes management. | Baseline, week 4 & 6 months |
Average number of diabetes educator hours used per study participant at week 4 & 6 months. | Number of hours spent in diabetes education | Week 4 and 6 months |
Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use | Name of questionnaire: Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree. | Week 4 & 6 months |
Mean change in perceived burden of Continuous Glucose Monitor (CGM) use | Name of questionnaire: Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree. | Week 4 & 6 months |
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
8 Years
対象性別
全て
- Current age of 8-21 years;
- T2D diagnosis;
- Able to speak, read, and write English or Spanish
a. Known history of medical adhesive allergies;
Children's Hospital Los AngelesNational Institute on Minority Health and Health Disparities (NIMHD)責任者
Barber, Rebecca, 主任研究者, Nurse Scientist, Children's Hospital Los Angeles
試験中央連絡先
連絡先: Natalia Garban, 3233611359, [email protected]
連絡先: Rebecca Barber, 3233611359, [email protected]
1 1カ国の場所
California
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States
Natalia Garban, 連絡先, [email protected]
Rebecca Barber, PhD, RN, 主任研究者
募集中