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Perioperative Continuous Glucose Monitoring (CGM) 22

中止
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 NCT05937373 (CGM) は 介入研究 臨床試験 で、糖尿病 に関するものです。現在は 中止 で、2023年8月4日 から開始しています。22 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、2024年5月21日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月24日 です。
概要
To evaluate use of continuous glucose monitoring (CGM) technology in the preoperative setting: evaluate feasibility of placement of CGM during preoperative clinic visit with intent to utilize CGM throughout perioperative period.
詳細説明
To further study potential barriers related to loss of continuous glucose monitoring (CGM) data as it relates to use of electrocautery and grounding devices utilized in the perioperative setting. To assess how CGM technology could improve glycemic management in the perioperative setting, specifically in predicting and preventing hypoglycemic episodes as well as utilization for treating hyperglycemia with resultant im...もっと見る
公式タイトル

A Pilot Trial of Continuous Glucose Monitoring (CGM) Technology in Preoperative Assessment Clinic

疾患名
糖尿病
その他の研究識別子
  • CGM
  • IRB00097714
NCT番号
NCT05937373
開始日
2023-08-04
最終更新日
2025-12-24
終了予定日
2024-05-21
目標参加者数
22
試験の種類
介入研究
治験の相・段階
該当なし
状況
中止
キーワード
A1c
blood glucose changes
hyperglycemic and hypoglycemic events
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Continuous Glucose Monitor
CGM placed preoperative to monitor blood glucose and insulin correction to achieve perioperative glucose management
持続血糖モニター
Perioperative glucose management beginning preoperative through postoperative monitoring
実薬対照薬Standard of Care
no study intervention-conventional glucose management per subjects medical providers as standard of care
標準治療
no study intervention. participant follows current medical providers recommendations for glucose management
主要評価項目
評価指標指標の説明時間枠
Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Fingerstick Values
Accuracy of CGM technology utilizing Dexcom G6 CGM and Freestyle Libre 2.0 CGM in the perioperative setting for glycemic management of patients with hyperglycemia and/or diabetes mellitus compared with current standard of care utilizing point of care blood glucose fingerstick Glucose values - Only Glucometers
Day 7
Disparities (Percentage Difference) in Continuous Glucose Monitoring (CGM) Accuracy - Comprehensive Metabolic Panel (CMP) / Basic Metabolic Panel (BMP)/ Blood Gas Values - Overall Number of Unit Analyzed (Glucose Values Each Group)
Accuracy of CGM technology utilizing Dexcom G6 CGM and Freestyle Libre 2.0 CGM in the perioperative setting for glycemic management of patients with hyperglycemia and/or diabetes mellitus compared with current standard of care utilizing serum and arterial glucose values - Comprehensive Metabolic Panel (CMP) / Basic Metabolic Panel (BMP)/ blood gas values For each CMP/BMP/Blood Gas Value recorded in the Electronic Medical Record during the period of CGM wear, a percentage difference was calculated between the measured glucose value and the corresponding CGM value.
Day 7
副次評価項目
評価指標指標の説明時間枠
Percentage of Patients With Functioning Continuous Glucose Monitoring (CGM) - Arrived on Their Date of Surgery (DOS) With Working CGM
Proportion of patients who present on day of surgery with CGM still in place and functioning
Day 7
Disparities in Continuous Glucose Monitoring (CGM) Accuracy - Interference Amount
Analysis of potential electrocautery interference in CGM data collection was performed through visual review of the CGM glucose data graphs for unexpected gaps or spikes during surgery. No such events were observed in the CGM outputs during the review. Disparities in CGM accuracy due to interference were reported as 0%.
Hour 24
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
  • Participants that are 18 years of age or older with hyperglycemia and/or diabetes mellitus who will be undergoing surgery at Atrium Health Wake Forest Baptist
  • smartphone compatible with Libre 2 phone application

  • Pregnant women will not be excluded from this study
  • Participants undergoing surgery that would limit the placement of Continuous Glucose Monitoring (CGM) to the posterior aspect of the upper extremity will be excluded from this study
  • neurosurgical type of surgery
Wake Forest University Health Sciences logo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
連絡先情報がありません。
1 1カ国の場所

North Carolina

Wake Forest Health Sciences, Winston-Salem, North Carolina, 27157, United States