治験レーダーAI | ||
|---|---|---|
治験 NCT03175315 (FLASH)（対象：糖尿病）は完了です。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
タイル表示
Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring (FLASH) 216 無作為化
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 NCT03175315 (FLASH) は 介入研究 臨床試験 で、糖尿病 を対象とした研究でした。現在は 完了 です。2017年5月2日 に開始し、216 名の参加者 が参加しました。この試験は Norbert Hermanns によって主導され、2018年3月9日 に完了しました。ClinicalTrials.gov からの最新更新日は 2018年8月3日 です。
概要
This study is a randomized, controlled, prospective trial with a 6-month follow- up. A newly developed psychoeducational treatment and education programme for diabetic patients on an insulin therapy who use flash glucose monitoring (FGM) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are...もっと見る
詳細説明
The investigators developed a new psychoeducational treatment and education program - called FLASH - for diabetic patients on an intensive insulin therapy who use flash glucose monitoring (FGM).
FLASH is a self-management-based treatment and education program. It is designed to empower patients to adequately use FGM in daily life and to train patients how to analyze their glucose data. FLASH consists of four lessons...
もっと見る公式タイトル
Evaluation of a Newly Developed Psychoeducational Treatment and Education Program for People With Type 1 and Type 2 Diabetes on an Intensified Insulin Therapy Who Use Flash Glucose Monitoring
疾患名
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
- FLASH
- NH052017
NCT番号
開始日
2017-05-02
最終更新日
2018-08-03
終了予定日
2018-03-09
目標参加者数
216
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
psychoeducation
treatment and education programme
self-management
diabetes education
flash glucose monitoring
treatment and education programme
self-management
diabetes education
flash glucose monitoring
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 |
|---|---|
実験的FLASH Intervention: Conduct of the newly developed treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH).
FLASH consists of 4 lessons focusing on empowering patients to autonomously use flash glucose monitoring (FGM) in their daily routine. Patients learn to effectively interpret the different information provided by FGM in order to improve not only glycemic control but also t...もっと見る | Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators. |
非介入Waiting List Diabetic patients using FGM receive treatment as usual until the last measurement point. After completion of the study, they are offered participation in the FLASH program. | 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 |
|---|---|---|
Changes in Glycemic Control Measured by A1c | Difference between baseline A1c and A1c at the 6-month follow-up | 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Changes in "time-in-range" | Difference in the duration of glycemic values spent between 70 mg/dl and 180 mg/dl between baseline and the 6-month follow-up | 6 months |
Changes in hypoglycemic episodes | Differences between the frequency of hypoglycemic glucose values (\<70 mg/dl) (baseline vs. follow-up) | 6 months |
Changes in the duration of hypoglycemic episodes | Differences between the duration of hypoglycemic glucose values (\<70 mg/dl) (baseline vs. follow-up) | 6 months |
Changes in hyperglycemic episodes | Differences between the frequency of hyperglycemic glucose values (\>180 mg/dl) (baseline vs. follow-up) | 6 months |
Changes in the duration of hyperglycemic episodes | Differences between the duration of hyperglycemic glucose values (\>180 mg/dl) (baseline vs. follow-up) | 6 months |
Hypoglycaemia Awareness | The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness. | 6 months |
Diabetes Empowerment | Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy. | 6 months |
Diabetes Distress | The Diabetes Distress Scale (DDS-28) assesses diabetes-related stressors due to living and treating diabetes. Different aspects of distress are covered such as hypoglycemia-related distress, physician-related distress | 6 months |
Problem Areas in Diabetes | The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes. | 6 months |
Depressive symptoms | The presence and extent of typical depressive symptoms are assessed via self-report. | 6 months |
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
16 Years
対象性別
全て
- Intensified insulin therapy / insulin pump therapy
- previous participation in a structured diabetes education program
- HbA1c ≥ 7,5% but ≤ 14%
- Reduction of HbA1c as therapeutic goal
- Indication for using FGM
- Ability to understand, speak and write German language
- informed consent (if necessary, informed consent of the parents)
- Diabetes duration < 1 year
- Type 2 diabetes without insulin or non-intensified insulin therapy
- severe organic disease preventing a regular participation in the training course
- pregnancy
- severe cognitive impairment
- current treatment of psychiatric disorder
- renal disease requiring dialysis
Norbert Hermanns責任者
Norbert Hermanns, 治験依頼者・主任研究者, CEO, Forschungsinstitut der Diabetes Akademie Mergentheim
連絡先情報がありません。
1 1カ国の場所
Diabetes und Stoffwechselpraxis Wetter, Wetter, 58300, Germany