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CGM Adherence Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes (PRECIOUS) 70 無作為化 妊娠中

募集中
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 NCT07184775 (PRECIOUS) は 介入研究 臨床試験 で、2型糖尿病 (T2DM)、妊娠、Continuous Glucose Monitoring System に関するものです。現在は 募集中 で、2025年10月1日 から開始しています。70 名の参加者 の募集が計画されています。この試験は トーマス・ジェファーソン大学 によって主導され、2026年3月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月14日 です。
概要
The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hy...もっと見る
詳細説明
About 1-2% of pregnant patients in the United States have pregestational type 2 diabetes (T2DM). The current standard of care for patients needing pharmacotherapy is to initiate basal and postprandial insulin as determined by the patient's reported blood glucose levels after a week of finger-stick glucose monitoring (FSG). This approach is dependent on the patient performing four finger sticks daily and keeping a rec...もっと見る
公式タイトル

Maternal Continuous Glucose Monitoring Surveillance Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes

疾患名
2型糖尿病 (T2DM)妊娠Continuous Glucose Monitoring System
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
  • PRECIOUS
  • iRISID-2024-1410
NCT番号
NCT07184775
開始日
2025-10-01
最終更新日
2025-10-14
終了予定日
2026-03-01
目標参加者数
70
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Type 2 Diabetes
Diabetes
continuous glucose monitor
CGM
adherence
pregnancy
maternal health
prenatal care
glucose monitoring
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
実薬対照薬Continuous glucose monitoring
Patients in this arm of the study will use a continuous glucose monitoring device for glucose monitoring throughout their pregnancy, linked with a HIPAA-compliant digital application that will document measurements.
持続血糖モニター
Continuous glucose monitors are sensors that detect interstitial blood glucose measurements and relay values from their sensor to a receiver (typically a cell phone) to document values every 5 minutes.
実薬対照薬Finger stick blood glucose monitoring
Patients randomized to this arm will perform finger stick blood glucose measurements 4x daily (fasting and 2 hours after each meal) and document their measurements in a glucose log.
Glucometer
Glucometer measurement involves a patient performing a finger stick with a lancet to draw blood. They then apply blood to a test strip which is analyzed by a glucometer. The glucose measurement provided by the glucometer is then recorded by the patient in a glucose log.
主要評価項目
評価指標指標の説明時間枠
Patient glucose monitoring adherence
Compare adherence to glucose monitoring using continuous glucose monitoring versus finger stick monitoring in pregnant patients with Type 2 Diabetes
through pregnancy episode, typically 20-35 weeks
副次評価項目
評価指標指標の説明時間枠
Fetal/neonatal outcomes
Evaluate differences in fetal/neonatal composite morbidity or mortality between groups, including the following measures: stillbirth, miscarriage, large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age, fetal hypoglycemia defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, or birth trauma.
through pregnancy episode, typically 20-35 weeks
Maternal outcomes
Determine rates of composite maternal severe morbidity or mortality between groups, including the following measures: maternal hypoglycemia \< 60 mg/dL, shoulder dystocia, OASIS Injuries, operative delivery or cesarean section, postpartum hemorrhage, or hypertensive disorder of pregnancy.
through pregnancy episode, typically 20-35 weeks
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
女性
  • singleton pregnancies
  • fetuses without anomalies
  • diagnosis of Type 2 diabetes
  • initiation of prenatal care at <20 weeks gestation

  • diagnosis of Type 1 diabetes
  • allergy to insulin
  • inability to wear a continuous glucose monitor
Thomas Jefferson University logoトーマス・ジェファーソン大学130 件のアクティブな治験を探索
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University logoSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
責任者
Huda Al-Kouatly, 主任研究者, Associate Professor, Maternal-Fetal Medicine, Medical Genetics and Genomics, Thomas Jefferson University
試験中央連絡先
連絡先: Brandy Firman, 215-955-8401, [email protected]
2 1カ国の場所

New Jersey

Jefferson Health New Jersey, Sewell, New Jersey, 08080, United States
Brandy Firman, 連絡先, 215-955-8401, [email protected]
募集中

Pennsylvania

Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States
Brandy Firman, 連絡先, 215--955-8401, [email protected]
募集中