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治験 NCT06852950（対象：2型糖尿病 (T2DM)、Type 1 Diabetes Mellitus (T1DM)、高血糖）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。 | ||
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ヴァンダービルト大学Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge 60
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 NCT06852950 は 介入研究 臨床試験 で、2型糖尿病 (T2DM)、Type 1 Diabetes Mellitus (T1DM)、高血糖 に関するものです。現在は 募集中 で、2025年3月9日 から開始しています。60 名の参加者 の募集が計画されています。この試験は ヴァンダービルト大学 によって主導され、2027年1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5日 です。
概要
This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.
公式タイトル
Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge
疾患名
2型糖尿病 (T2DM)Type 1 Diabetes Mellitus (T1DM)高血糖その他の研究識別子
- 242071
主目的
その他
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Libre 3 Plus Continuous Glucose Monitor Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor. | Libre 3 Plus Continuous Glucose Monitor Subjects in this arm will start using the Libre 3 Plus continuous glucose monitor. |
実験的Dexcom G7 Continuous Glucose Monitor Subjects in this arm will start using the Dexcom G7 continuous glucose monitor. | Dexcom G7 Continuous Glucose Monitor Subjects in this arm will start using the Dexcom G7 continuous glucose monitor. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system | Questionnaire responses regarding patient satisfaction and opinion regarding use of continuous glucose monitoring system: regarding how do subjects feel that using CGM impacted their glucose control on a scale of 1-5, with 1=strongly made it worse, 2=somewhat made it worse, 3=did not make it better or worse, 4=somewhat made it better, and 5=strongly made it better?; regarding what is the overall opinion of subject's experience with CGM use on a scale of 1-5, with 1=very negative, 2=negative, 3=neutral, 4=positive, 5=very positive. | From enrollment until follow-up telephone visit 2-3 weeks after discharge |
Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care | Questionnaire responses regarding patient satisfaction and opinion regarding quality of diabetes care: regarding how do subjects feel that using CGM impacted the diabetes care overall on a scale of 1-5, with 1=strongly made it worse, 2=somewhat made it worse, 3=did not make it better or worse, 4=somewhat made it better, and 5=strongly made it better. | From enrollment until follow-up telephone visit 2-3 weeks after discharge |
Questionnaire responses regarding patient familiarity with continuous glucose monitoring | Questionnaire responses regarding patient familiarity with continuous glucose monitoring: regarding degree of familiarity of CGMs in general and the different types of information provided by CGMs, what is the subject's familiarity on a scale of 1-5, with 1=very unfamiliar, 2=unfamiliar, 3=neutral, 4=familiar, 5=very familiar. | From enrollment until follow-up telephone visit 2-3 weeks after discharge |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Degree of Average Change in Hemoglobin A1C from Start to End of Study | Degree of average change in Hemoglobin A1C from start to end of study | From enrollment until follow-up telephone visit 2-3 weeks after discharge |
Degree of Average Change in Glucose Management Indicator (GMI) | Degree of average change in glucose management indicator (GMI) | From enrollment until follow-up telephone visit 2-3 weeks after discharge |
Number of Participants with 30-day Readmissions Related to Glycemic Control | Number of participants with 30-day Readmissions Related to Glycemic Control (hyperglycemia, hypoglycemia, or diabetic ketoacidosis) | From enrollment until follow-up telephone visit 2-3 weeks after discharge |
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
- Non-pregnant adults, ages greater than or equal to 18 years, admitted to VUMC
- Able to give informed consent
- Hyperglycemia requiring insulin therapy including subcutaneous insulin injection or continuous subcutaneous insulin infusion (patient's own insulin pump) during hospitalization and at the time of discharge
- POC glucose or venous glucose levels in the 24 hours prior to participation need to be 70-350 mg/dL
- Need glucose readings greater than or equal to one time per day
- Mental status and dexterity adequate to use Libre 3 Plus or Dexcom G7 sensors with Libre 3 or Dexcom G7 application on patient's smartphone
- Currently using Libre 3 Plus or Dexcom G7 CGMS during hospitalization or have used Libre 3 Plus or Dexcom G7 CGMS in the past 3 months
- Does not have smartphone compatible with Libre 3 App or Dexcom G7 App
- Received chemotherapy during current hospitalization
- Planning on major surgery within 10-15 days
- Hemodialysis or peritoneal dialysis
- Requiring vasopressors, intubation, sedation, or admission to an intensive care unit
- Vitamin C use of more than 500 milligrams per day
- Hydroxyurea use
- Acetaminophen use of more than 4 grams per day or 1 gram every 6 hours
- Significant pitting edema (3+ or greater) i.e. cirrhosis with ascites, congestive heart failure with edema, nephrotic syndrome, or signs of poor perfusion
- Presentation in diabetic ketoacidosis or hyperosmotic nonketotic state
- Skin allergy to adhesives
ヴァンダービルト大学344 件のアクティブな治験を探索責任者
Angel Morvant, 主任研究者, Principal Investigator, Vanderbilt University Medical Center
試験中央連絡先
連絡先: Angel Morvant, MD, 615-343-8332, [email protected]
1 1カ国の場所
Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
Angel Morvant, MD, 連絡先, (615) 343-8332, [email protected]
Angel Morvant, MD, 主任研究者
募集中