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治験 NCT05714761（対象：妊娠糖尿病）は完了です。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
Postpartum Continuous Glucose Monitoring (CGM) Study 50 産後
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 NCT05714761 は 介入研究 臨床試験 で、妊娠糖尿病 を対象とした研究でした。現在は 完了 です。2023年2月16日 に開始し、50 名の参加者 が参加しました。この試験は Icahn School of Medicine at Mount Sinai によって主導され、2024年3月8日 に完了しました。ClinicalTrials.gov からの最新更新日は 2025年3月20日 です。
概要
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study...もっと見る
公式タイトル
Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
疾患名
妊娠糖尿病その他の研究識別子
- STUDY-20-02062
NCT番号
開始日
2023-02-16
最終更新日
2025-03-20
終了予定日
2024-03-08
目標参加者数
50
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
gestational diabetes
oral glucose tolerance test
glucose sensor
oral glucose tolerance test
glucose sensor
主目的
診断
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 |
|---|---|
その他Postpartum glucose sensor Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test. | Dexcom glucose sensor Use of a Dexcom G6 Pro |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of Participants With at Least 72 Hours of CGM Data Downloaded. | Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded. | Postpartum days 10-20 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Specificity | Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition.
Specificity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported. | up to 12 weeks postpartum |
Sensitivity | Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases.
Sensitivity for Time in Range 70-180 mg/dL of \<96% for abnormal OGTT is reported. | up to 12 weeks postpartum |
Positive Predictive Value (PPV) | PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease.
Positive predictive value (PPV) of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
Positive Likelihood Ratio (PLR) | PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition.
PLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
Negative Predictive Value (NPV) | NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease.
NPV of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
Negative Likelihood Ratio (NLR) | NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition.
NLR of Time in Range 70-180 mg/dL of \<96% to predict abnormal OGTT is reported. | up to 12 weeks postpartum |
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
女性
- include diagnosis of gestational diabetes during a current or recent pregnancy
- age 18 or older.
- include known pregestational diabetes,
- known skin adhesive allergy which would prevent subject from wearing a CGM,
- chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
Icahn School of Medicine at Mount SinaiDexCom, Inc.責任者
Grenye O'Malley, 主任研究者, Assistant Professor, Icahn School of Medicine at Mount Sinai
連絡先情報がありません。
1 1カ国の場所
New York
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States