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治験 NCT03326232（対象：妊娠糖尿病）は状況不明です。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
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Real-time Continuous Glucose Monitoring 40 食事療法
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 NCT03326232 は 介入研究 臨床試験 で、妊娠糖尿病 に関するものです。現在は 状況不明 で、2017年11月13日 から開始しています。40 名の参加者 の募集が計画されています。この試験は Eastern Virginia Medical School によって主導され、2018年7月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2017年11月24日 です。
概要
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and continues to rise with the increase in obesity and type-2 diabetes. GDM places the pregnancy at great risk to both the mother and the neonate. Recent studies have proven that interventions including dietary and medications lower the risk to...もっと見る
詳細説明
The investigators' proposed study will add new information to the emerging use of CGM in pregnant women with GDM. First, most studies only use CGM for 48 - 72hours at a time, while the investigators will be using CGM for 7 day intervals. Both groups will use the same Enlite sensor (Medtronic). The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + transmitter). The real-time CGM group will be...もっと見る
公式タイトル
Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized Trial
疾患名
妊娠糖尿病刊行物
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
- 17-07-FB-0181
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 |
|---|---|
実験的Blinded continuous glucose monitoring The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). | 持続血糖モニタリング The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter) |
実験的Real time continuous glucose monitoring The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter) | 持続血糖モニタリング The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter) |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Mean blood glucose (mg/dL) | Mean blood glucose (mg/dL) in the real-time CGM group compared to self-monitoring of blood glucose (SMBG) group during the 4th week of study from data collected on the 6 day of CGM use during that week. | week 1 vs. week 4 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Failed dietary therapy | Failed dietary therapy (started on medication), | week 1 vs. week 4 |
Time spent in normoglycemia | Time spent in normoglycemia (min/day) | week 1 vs. week 4 |
Time spent in hypoglycemia | Time spent in hypoglycemia (min/day) | week 1 vs. week 4 |
BMI at time of delivery | BMI at time of delivery (kg/m2) | BMI at time of delivery |
Gestational hypertension | Gestational hypertension (defined as systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mmg Hg, on 2 occasions at least 4 hrs apart | enrollement vs delivery. |
Preeclampsia | Preeclampsia (defined as gestational hypertension plus either new-onset proteinuria (\> 300 mg/24 2hrs, protein:creatinine \> 0.3 mg/dL), thrombocytopenia (platelet count \< 100,000/uL), elevated Aspartate aminotransferase or alanine aminotransferase (\> 2x upper limit of normal), renal insufficiency (serum creatinine \> 1.1 mg/dL or an unexplained doubling of creatinine), pulmonary edema, or cerebral or visual symptoms | enrollement vs delivery. |
HbA1C values | HbA1C values (%) | HbA1C values week 1 compared to week 4 (%) |
Polyhydramnios | Polyhydramnios (MVP \> 8 cm at any point in the pregnancy) | Through study completion, an average of 9 months |
Cesarean delivery | Cesarean delivery (w/ indication: macrosomia, malpresentation, failed induction, fetal distress, failed trial of labor after cesarean, scheduled repeat, other) | Delivery |
Induction of labor | Induction of labor (w/ indication) | Delivery |
Operative vaginal delivery | Operative vaginal delivery (yes/no) and type (forceps/vacuum) | Delivery |
Shoulder dystocia | Shoulder dystocia (diagnosed clinically) | Delivery |
Fetal macrosomia | Fetal macrosomia (\> 4,000g at 38 wk u/s) | Most recent ultrasound before delivery |
3rd or 4th degree perineal laceration | 3rd or 4th degree perineal laceration at time of delivery | Delivery |
Gestational age at delivery | Gestational age at delivery (weeks, days) | Delivery |
Preterm delivery | Preterm delivery (\< 37 weeks gestational age at birth) | Delivery |
Birth weight | Birth weight (grams) | Delivery |
Perinatal morbidity composite outcome | * Hypoglycemia (yes/no): \< 2 hrs after birth and before feeding, defined as \< 35mg/dL
* Hyperbilirubinemia (yes/no): collected 16-36 hrs after birth, defined as \> 95% for any given point after birth requiring phototherapy according to American Academy of Pediatrics guidelines
* Birth trauma (yes/no): brachial plexus injury or clavicular, humeral, or skull fracture
* Intrauterine fetal demise or neonatal death (yes/no): prior to hospital discharge | Delivery |
Large for gestational age | Large for gestational age (yes/no): defined as birth weight \> 90% | Delivery |
Small for gestational age | Small for gestational age (yes/no): defined as birth weight \< 10% | Delivery |
Admission to neonatal intensive care unit | Admission to neonatal intensive care unit (yes/no) and length of neonatal intensive care unit stay (days) | Delivery |
Respiratory distress syndrome | Respiratory distress syndrome (defined as need to supplemental oxygen \> 4 hrs after birth) | Delivery |
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
女性
- maternal age 18 to 45
- singleton gestation
- gestational age less than 32 weeks gestation at study inclusion
- BMI less than 45
- 50g glucose challenge greater than 135 mg/dL
- 100 g 3 hr oral glucose tolerance test greater than 2 abnormal values using the Carpenter Coustan cut offs (fasting greater than 95 mg/dL, 1 hr greater than 180 mg/dL, 2 hr greater than 155 mg/dL, 3 hr greater than 140 mg/dL)
- attended the maternal-fetal medicine diabetes education class
- maternal age less than18 or greater than 45
- multifetal gestation
- gestational age greater than 32 weeks study inclusion
- BMI greater than 45
- pregestational diabetes
- gestational diabetes diagnosed before 24 weeks
- did not attend the diabetes education class
- known fetal anomaly
- known fetal aneuploidy
- required ongoing treatment with medications that can exacerbate hyperglycemia (steroids, hydroxyprogesterone caproate injections (Makena), highly active antiretroviral therapy HIV medications)
- learning disability
- concern for non compliance with medical care
- imminent preterm delivery due to maternal disease or fetal conditions
- is not willing to wear CGM
Eastern Virginia Medical SchoolMedtronic試験中央連絡先
連絡先: Joanne Audouin, MS, 757-446-5121, [email protected]
連絡先: Andrew Lane, MD, 864-608-4134, [email protected]
1 1カ国の場所
Virginia
Eastern Virginia Medical School, Norfolk, Virginia, 23507, United States
Joanne Audouin, MS, 連絡先, 757-446-5121, [email protected]
Andrew Lane, MD, 連絡先, 864-608-4134, [email protected]
Malgorzata Mlynarczyk, MD, PhD, 主任研究者
Andrew Lane, MD, 副研究者
Margarita de Veciana, MD, 副研究者
Alfred Abuhamad, MD, 副研究者
募集中