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治験 NCT06861881（対象：グルコース代謝障害（糖尿病を含む））は募集準備中です。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。 | ||
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ウェイクフォレスト大学Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass 100
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 NCT06861881 は 介入研究 臨床試験 で、グルコース代謝障害（糖尿病を含む） に関するものです。現在は 募集準備中 で、2026年5月1日 に開始予定です。100 名の参加者 の募集が計画されています。この試験は ウェイクフォレスト大学 によって主導され、2026年10月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月25日 です。
概要
The purpose of this research study is to test the accuracy of the Dexcom continuous glucose monitoring device during the cardiothoracic surgical procedure and recovery period in the Cardiac Intensive Care Unit. Readings from the device will be compared with the standard of care blood glucose levels that are obtained during your surgery and postoperatively.
詳細説明
The proposed study would examine 100 adult patients specifically undergoing cardiac surgical procedures with the explicit goal of comparing continuous glucose monitoring accuracy to point-of-care testing, particularly in the setting of physiologic perturbations due to vasopressors, acidosis, and hypothermia. With a large sample size and few stipulations on the included patients, this well-powered study would give bro...もっと見る
公式タイトル
Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
疾患名
グルコース代謝障害（糖尿病を含む）その他の研究識別子
- IRB00125789
NCT番号
開始日
2026-05
最終更新日
2026-03-25
終了予定日
2026-10
目標参加者数
100
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
continuous glucose monitoring
cardiopulmonary bypass
cardiac surgery
cardiopulmonary bypass
cardiac surgery
主目的
医療機器の実現可能性
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Continuous Glucose Monitoring All participants will wear the Dexcom G7 continuous glucose monitor continuously during their cardiothoracic surgery and throughout their time admitted to the Cardiovascular Intensive Care Unit. | Dexcom G7 Continuous Glucose Monitor Dexcom G7 continuous glucose monitor will be placed prior to cardiac surgery. It will be worn continuously throughout the perioperative period and during the time admitted to the Cardiovascular Intensive Care Unit. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Continuous Glucose Monitoring Accuracy Compared to Point-of-Care Measurements | Glucose values (mg/dL) from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas and/or fingerstick capillary glucose measurements. | Up to Day 10 |
Percentage of Continuous Glucose Monitoring Accuracy with Vasopressor Use | Glucose values from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas measurements when vasopressors are utilized for hemodynamic optimization. | Up to Day 10 |
Percentage of Continuous Glucose Monitoring Accuracy with Hypothermia | Glucose values from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas measurements during the hypothermic period intraoperatively. | Day 1 |
Percentage of Continuous Glucose Monitoring Accuracy with Acidosis | Glucose values from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas measurements intraoperatively when the participant is acidotic. | Up to Day 10 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Incidence of Continuous Glucose Monitor Malfunction | Number of times the Dexcom G7 continuous glucose monitor malfunctioned during use, including sensor loss or monitor failure. | Up to Day 10 |
Duration of Time Continuous Glucose Monitor Experienced Sensor Loss | Amount of time the Dexcom G7 continuous glucose monitor experienced sensor loss while in use. | Up to Day 10 |
Continuous Glucose Monitor Measurement Expenses | Total expenditures to the patient for the costs of all glucose measurements (arterial blood gases, glucometers as point of care, laboratory drawn glucose measurements - included in metabolic profile laboratory measurements as well) obtained during the course of wearing the continuous glucose monitoring device compared to the cost of the Dexcom G7 continuous glucose monitor. | Up to Day 10 |
参加アシスタント
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
- 18 years of age or older
- Undergoing cardiac surgery with cardiopulmonary bypass at Atrium Health Wake Forest Baptist Medical Center
- Under 18 years of age
- Pregnant women
- Patients with a contraindication to device placement on the posterior arm, including rash, missing extremity, or existing line or device
ウェイクフォレスト大学323 件のアクティブな治験を探索試験中央連絡先
連絡先: Megan H Hicks, MD, 336-716-4498, [email protected]
連絡先: Lynnette Harris, BSN RN, 336-716-8791, [email protected]
1 1カ国の場所
North Carolina
Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States
Lynnette Harris, BSN, RN, 連絡先, 336-716-8791, [email protected]
Megan Hicks, MD, 主任研究者