Real-Time Continuous Glucose Monitoring (RT-CGM) in Patients With Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY)
調査の概要
詳細な説明
In a randomized controlled trial the primary hypothesis is tested if the usage of RT-CGM in the intervention group (CGM group) reduces the frequency of glucose values <55 mg/dl in patients with hypoglycemia problems (hypoglycemia unawareness or documented previous severe hypoglycemia) significantly more than in the control group receiving usual care (without CGM).
Secondary is tested if patients in the CGM group showed a significantly more favorable change in the below defined secondary endpoint than patients in the control group after 26 weeks follow up.
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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Aschaffenburg、ドイツ
- Gemeinschaftspraxis Dres. Klausmann
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Bad Heilbrunn、ドイツ
- m&i-Fachklinik Bad Heilbrunn
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Bad Mergentheim、ドイツ
- Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
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Bergheim、ドイツ
- Diabetologische Schwerpunktpraxis
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Berlin、ドイツ
- Medicover Berlin-Mitte
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Duisburg、ドイツ
- Diabetologikum Duisburg
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Essen、ドイツ
- Diabetes Praxis Essen
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Essen、ドイツ
- Diabetologische Schwerpunktpraxis mit Fußambulanz
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Hamburg、ドイツ
- Zentrum für Diabetologie Bergedorf
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Leverkusen、ドイツ
- Gemeinschaftspraxis Dres. Kaltheuner
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Marktredwitz、ドイツ、95615
- Diabetes Schwerpunkt Praxis Zentrum für Hormone und Stoffwechsel
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Münster、ドイツ、48153
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin
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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:
- Patients with type 1 diabetes for at least 12 months on multiple daily injections (MDI). MDI is defined as prandial insulin injections at each major meal (excludes pre-mixed insulin) with doses determined by SMBG and carbohydrate counting, and basal insulin injection(s)
- Age ≥ 18 years
- HbA1c ≤ 9.0 % performed within 4 months before begin of the study
- High risk for severe hypoglycemia (defined as a score of 4 or higher on the Hypoglycemia unawareness scale (HUS) or a history of at least one severe hypoglycemic event in the last 12 months (required third part assistance, not able to treat themselves))
- Willing to not use paracetamol or drugs containing it
- Signed and dated Informed Consent Form
Exclusion Criteria:
- Use of personal real-time-CGM 3 months prior to study entry and during the study (except study devices)
- Use of a flash-glucose monitoring system 3 months prior to study and during the study
- Alcoholism or drug abuse
- Unable to comply with the protocol at the investigators discretion, such as known psychiatric diagnosis, cognitive / physical decline
- Pregnancy or lactation period
- Severe known allergies, e.g. against plaster
- Mental incapacity or language barriers precluding adequate compliance with the study procedures
- Limited or no legal capacity or legal guardianship
- Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research center or their families)
- Participation in another study at the same time with a non-approved drug or a non-CE-labelled medical device.
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
- 割り当て:ランダム化
- 介入モデル:並列代入
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:対照群
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実験的:CGM group
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他の名前:
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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 |
時間枠 |
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Change in the total number of low glucose events (<55 mg/dl), between baseline and outcome phase (week 22-26) in CGM group and control group (change = subtracting number of follow up events from number of baseline events
時間枠:For each subject, the experimental phase has an expected duration of up to 7 months
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For each subject, the experimental phase has an expected duration of up to 7 months
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協力者と研究者
協力者
捜査官
- 主任研究者:Norbert Hermanns, Prof.、Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
出版物と役立つリンク
一般刊行物
- Hermanns N, Ehrmann D, Heinemann L, Freckmann G, Waldenmaier D, Calhoun P. Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials. Diabetes Technol Ther. 2022 Sep;24(9):603-610. doi: 10.1089/dia.2022.0130. Epub 2022 Jun 10.
- Waldenmaier D, Freckmann G, Pleus S, Hermanns N, Ehrmann D, Heinemann L, Haug C. Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study. BMJ Open Diabetes Res Care. 2021 Apr;9(1):e001848. doi: 10.1136/bmjdrc-2020-001848.
- Heinemann L, Freckmann G, Ehrmann D, Faber-Heinemann G, Guerra S, Waldenmaier D, Hermanns N. Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet. 2018 Apr 7;391(10128):1367-1377. doi: 10.1016/S0140-6736(18)30297-6. Epub 2018 Feb 16.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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