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治験 NCT06314061 (WARD-glucose)（対象：糖尿病、血糖異常、周術期合併症）は募集中です。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。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes. (WARD-glucose) 第IV相・フェーズ4 200
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治験番号 NCT06314061 (WARD-glucose) は 糖尿病、血糖異常、周術期合併症 に関する 治療 の研究で、第IV相・フェーズ4 介入研究 臨床試験 です。現在は 募集中 で、2024年6月24日 から開始しています。200 名の参加者 の募集が計画されています。この試験は Christian S. Meyhoff によって主導され、2026年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月4日 です。
概要
The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.
The main question it aims to answer is:
• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard ...
もっと見る詳細説明
This is a prospective randomised controlled multicentre trial on patients living with diabetes who undergo surgery at Rigshospitalet, Copenhagen University, Bispebjerg and Frederiksberg Hospital, Copenhagen University, and Zealand University Hospital, Køge, Denmark
The study aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control. The Dexcom...
もっと見る公式タイトル
The Effect of Continuous Glucose Monitoring With Real-time Alerts on Glycaemic Control in Surgical Patients With Diabetes: A Randomised, Clinical Multicentre Trial
疾患名
糖尿病血糖異常周術期合併症刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- WARD-glucose
- WARD-glucose RCT v.2.2
NCT番号
開始日
2024-06-24
最終更新日
2025-12-04
終了予定日
2026-06-01
目標参加者数
200
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
募集中
キーワード
Diabetes Mellitus
Continuous glucose monitoring
Perioperative medicine
Medical devices
Continuous glucose monitoring
Perioperative medicine
Medical devices
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
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Intervention group Participants in the intervention group will wear the CGM-device Dexcom G7, and real-time alerts on dysglycaemia and rapidly increasing or falling glucose levels will alert the nursing staff. | Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) A continuous glucose monitor which through a sensor in the skin registers glucose levels every 5 minutes. Glucose levels are shown by connecting the sensor to a mobile device or the Dexcom G7 Receiver where realtime alerts on deviating glucose levels will be sent. |
非介入Control group Participants in the control group will wear a blinded CGM device. The nursing staff will monitor glucose levels with standard care using POC blood glucose measurements. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Time in range (TIR) of CGM glucose levels | Time in range (TIR) of CGM glucose levels (6.0-10.0 mmol/l) in minutes per 24 hours after discharge from the post-anaesthesia care unit (PACU) until 10 days postoperative (or until discharge) | Perioperatively |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Duration of hypoglycaemia | Duration of hypoglycaemia (\<3.9 mmol/L (\<70 mg/dL), assessed by CGM, in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge) | Perioperatively |
Duration of hyperglycaemia | Duration of hyperglycaemia (\>10.0 mmol/L (\>180 mg/dL), assessed by CGM, in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge) | Perioperatively |
Number of hypoglycaemia events | Number of hypoglycaemia (\<3.9 mmol/L (\<70 mg/dL) events lasting \> 15 minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Events will be reported as number of events per 24 hours and duration of events (defined from period of first detected deviation until the first reading in a normal glucose level | Perioperatively |
Number of hyperglycaemia events | Number of hyperglycaemia (\>10.0 mmol/L (\>180 mg/dL) events lasting \> 15 minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Events will be reported as number of events per 24 hours and duration of events (defined from period of first detected deviation until the first reading in a normal glucose level | Perioperatively |
Complications | Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days | 30 days postoperatively |
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
- Medical history with diabetes mellitus (DM1 or DM2 (insulin-dependent and non-insulin-dependent) requiring antidiabetic drug(s)
- Acute or elective abdominal, orthopaedic, urological, or vascular surgery with estimated duration of surgery >45 minutes
- Expected stay for at least one night in the hospital postoperatively
- Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area
- Known allergy to the equipment plaster
- Known pregnancy
- Patients with pacemaker or implantable cardioverter defibrillator (ICD) device
- Previous or currently scheduled for pancreatectomy (complete or partial)
- Patients receiving hydroxyurea (these drugs may interfere with CGM readings)
Christian S. Meyhoff- 🏥Rigshosp...
責任者
Christian S. Meyhoff, 治験依頼者・主任研究者, Professor, head of research, MD, PhD, University Hospital Bispebjerg and Frederiksberg
試験中央連絡先
連絡先: Casper Pedersen, MD, +4526712696, [email protected]
連絡先: Christian S Meyhoff, MD, PhD, +4524910542, [email protected]
3 1カ国の場所
The Capital Region of Denmark
Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Copenhagen, The Capital Region of Denmark, 2100, Denmark
Eske K Aasvang, MD, DMSc, 連絡先, [email protected]
募集中
Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital, Copenhagen, The Capital Region of Denmark, 2400, Denmark
Christian S Meyhoff, MD, PhD, 連絡先, [email protected]
募集中
Zealand University Hospital, Køge, 4600, Denmark
Annelotte Philipsen, MD, PhD, 連絡先, [email protected]
募集中