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治験 NCT02572856 (CGM)（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。 | ||
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ワシントン大学Continuous Glucose Monitoring During and After Surgery (CGM) 10
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 NCT02572856 (CGM) 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。2018年8月1日 に開始し、10 名の参加者 が参加しました。この試験は ワシントン大学 によって主導され、2021年11月16日 に完了しました。ClinicalTrials.gov からの最新更新日は 2023年8月31日 です。
概要
During surgery and after surgery elevated blood glucose levels can lead to poor outcome such as wound infections. Current technology does not allow close monitoring of glucose levels often resulting in poor management of glucose levels. In this study, the investigators will evaluate the feasibility of using a continuous glucose monitor (Dexcom Gen 6 Professional) during and after surgery. Such a monitor has the poten...もっと見る
詳細説明
During surgery high blood glucose levels, termed hyperglycemia, are commonly encountered due to the physiological stress. Hyperglycemia has been associated with complications such as surgical site infections, adverse cardiovascular and pulmonary events. Optimal glucose control targeted at preventing hyperglycemia has been shown to reduce the risk of complications. However, performing optimal glycemic management durin...もっと見る
公式タイトル
Continuous Glucose Monitoring During and After Surgery
疾患名
糖尿病その他の研究識別子
- CGM
- STUDY00003457
- IIS-2014-028 (その他の助成金/資金番号) (Dexcom Inc)
NCT番号
開始日
2018-08-01
最終更新日
2023-08-31
終了予定日
2021-11-16
目標参加者数
10
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
Feasibility
continuous glucose monitor
surgery
continuous glucose monitor
surgery
主目的
その他
割付方法
該当なし
介入モデル
単一群割当
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CGM patients Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider | Continuous Glucose Monitor (CGM) Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Safety and Feasibility Evaluation - Number of Unanticipated Safety Issues | After CGM has been applied on the first 4 patients, the study team will evaluate the safety and feasibility of using CGM. Specifically, the team will check whether there are unanticipated adverse events such as rashes or discomfort | After 4 patients (2 months) |
Mean Absolute Relative Difference for CGM and POC Glucose Measurements | Compare glucose measurements made by a Dexcom G4 Professional Continuous Glucose Monitor (CGM) against point of care glucose meter (Accu-Check Inform II, Roche Diagnostics), during the intraoperative and postoperative phases. Measured as mean absolute relative difference (MARD) for CGM glucose values compared with the POC glucose measurements. | 10 months |
Feasibility of Instrument: Count of CGM Instrument Issues | After 4 participants (2 months), the study team will assess the number of instrument breaks | After 4 participants (2 months) |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Adult (≥ 18 years) diabetic (both Type 1 & 2) patients who are self-monitoring glucose levels (via finger stick measurements) two to three times daily.
- Scheduled to have elective general surgery at UW Medical Center. Preferably target Surgery A- Orthopedic/GYN surgery/Bariatric patients.
- Proposed case duration > 2 hour case.
- Pregnant and lactating females
- MRI, CT & Diathermy procedure
ワシントン大学398 件のアクティブな治験を探索DexCom, Inc.責任者
David Flum, 主任研究者, Professor, School of Medicine: Surgery, University of Washington
連絡先情報がありません。
1 1カ国の場所
Washington
University of Washington Medical Center, Seattle, Washington, 98195, United States