Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring (FLASH)
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
調査の概要
状態
条件
詳細な説明
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 (90 minutes each).
FLASH is tested in a randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for FGM exists.
This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of FLASH will take place at the respective practice.
Baseline measurement will take place prior to the beginning of FLASH. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of FLASH, follow-up measurements will be conducted at the respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Time-in-range and the frequency and duration of hypo- and hyperglycemic episodes will be assessed via stored glucose data on patients FGM devices. The other secondary outcome measures will be assessed via psychometrically tested questionnaires or via patient files.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Wetter、ドイツ、58300
- Diabetes und Stoffwechselpraxis Wetter
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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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 to improve the implementation of insulin therapy in daily life. Psychological and motivational aspects of living with diabetes and handling of the FGM are addressed as well. |
Treatment and education program based on the self-management theory of behavioral medicine.
The program is delivered by certified and specially trained diabetes educators.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Glycemic Control Measured by A1c
時間枠：6 months
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Difference between baseline A1c and A1c at the 6-month follow-up
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in "time-in-range"
時間枠：6 months
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Difference in the duration of glycemic values spent between 70 mg/dl and 180 mg/dl between baseline and the 6-month follow-up
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6 months
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Changes in hypoglycemic episodes
時間枠：6 months
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Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
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6 months
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Changes in the duration of hypoglycemic episodes
時間枠：6 months
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Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
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6 months
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Changes in hyperglycemic episodes
時間枠：6 months
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Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
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6 months
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Changes in the duration of hyperglycemic episodes
時間枠：6 months
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Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
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6 months
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Hypoglycaemia Awareness
時間枠：6 months
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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.
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6 months
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Diabetes Empowerment
時間枠：6 months
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Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
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6 months
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Diabetes Distress
時間枠：6 months
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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
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6 months
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Problem Areas in Diabetes
時間枠：6 months
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The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
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6 months
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Depressive symptoms
時間枠：6 months
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The presence and extent of typical depressive symptoms are assessed via self-report.
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6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Norbert Hermanns, PhD、Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
出版物と役立つリンク
一般刊行物
- Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.
- Schipfer M, Albrecht C, Ehrmann D, Haak T, Kulzer B, Hermanns N. Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial. Trials. 2018 Feb 5;19(1):91. doi: 10.1186/s13063-018-2479-9.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NH052017
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