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The Use of a Continuous Glucose Monitoring System (Dexcom G6) in Hospitalized Patients for Acute Care 遠隔参加

撤回
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治験番号 NCT04385862 は 観察研究 臨床試験 で、持続血糖モニタリング に関するものです。現在は 撤回 で、2020年7月27日 から開始しています。該当なし 名の参加者 の募集が計画されています。この試験は Centre hospitalier de l'Université de Montréal (CHUM) によって主導され、2021年1月11日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2021年10月5日 です。
概要
The state of a coronavirus disease pandemic (COVID-19) was declared by the World Health Organization on March 11, 2020. Hospitalized patients receiving intravenous (IV) insulin therapy have been identified in the hospital setting as a group that places health care workers at high risk of contamination. Indeed, the many capillary blood glucose measurements required to adjust the IV insulin doses involve direct contact...もっと見る
公式タイトル

The Use of a Continuous Glucose Monitoring System (Dexcom G6) in Hospitalized Patients for Acute Care

疾患名
持続血糖モニタリング
その他の研究識別子
  • CGM-SI
NCT番号
NCT04385862
開始日
2020-07-27
最終更新日
2021-10-05
終了予定日
2021-01-11
試験の種類
観察研究
状況
撤回
キーワード
Continuous glucose monitoring
Intravenous insulin
Diabetes
Insulin
Glucose measurements
主要評価項目
評価指標指標の説明時間枠
To assess the validity of the Dexcom G6 CGM system measurements in IV insulin therapy patients hospitalized in the intensive care unit of the CHUM compared to the blood glucose measurements made using the Accuchek Inform II glucometer
3-10 days
副次評価項目
評価指標指標の説明時間枠
To assess the validity of the Dexcom G6 CGM system measurements compared to the different methods of glucose measurement and different blood sources in intensive care
Comparing the Dexcom G6 CGM system measurements to the different methods of glucose measurement and different blood sources in intensive care: Portable glucometer, on capillary blood, Portable glucometer, on venous or arterial blood, Central laboratory analyzes on venous or arterial blood
3-10 days
Assess the validity of the Dexcom G6 CGM system measurements compared to the glucometer, according to the glucose concentrations measured: <4.0 mmol / L 4.0 - 10.0 mmol / L > 10.0 mmol / L
3-10 days
To assess the validity of the Dexcom G6 CGM system measurements compared to the glucometer, according to the rate of change of glucose.
3-10 days
Measure the influence of the patient's clinical characteristics (age, sex, weight, presence of diabetes, septic state and need for organ supports), and biochemical (hematocrit, acidosis, renal function) on the validity of CGM values.
3-10 days
Assess the obstacles to the integration of the use of the CGM in the intensive care unit, namely the technical problems encountered and remote data management.
3-10 days
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
  • Adult patients (≥ 18 years old) admitted to intensive care at the CHUM
  • IV insulin infusion scheduled for a planned duration of at least 72 hours.

  • Magnetic resonance imaging planned, which would require removing the sensor less than 72 hours after installation;
  • Patient whose death is expected within the next 72 hours.
  • Patient included in the LOVIT study due to the theoretical risk of interference with blood glucose measurements with the CMS device
Centre hospitalier de l'Université de Montréal (CHUM) logoCentre hospitalier de l'Université de Montréal (CHUM)
連絡先情報がありません。
1 1カ国の場所
Centre Hospitalier de l'Université de Montréal, Montreal, Canada