治験レーダーAI | ||
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治験 NCT06957028（対象：妊娠中の妊娠糖尿病）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。 | ||
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy 6,000 妊娠中
(1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any h...
もっと見るData from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks.
- Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar.
- The blinded CGM sen...
CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
- IMAGINE
CGM
Pregnancy
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Glucose Lowering Group | Diabetes Treatment Management will include an unblinded CGM sensor worn 24/7, GDM specific nutrition information, training on using CGM in daily glucose management to achieve euglycemia (maximizing time 63-140 mg/dL \[3.5-7.8 mmol/L\]).
Visits (which could be telehealth) per usual obstetrical care for glycemia management (expected to be about every 4 weeks for most participants) and weekly glycemic management with review of CGM data b...もっと見る |
実薬対照薬Usual Care Group (with periodic blinded CGM) | 通常ケアグループ The control group will receive usual obstetrical care at the clinical center. A general pregnancy nutrition information handout will be provided to each participant and a blinded CGM sensor will be placed at routine obstetrical care visits and worn for 10-14 days each time throughout the pregnancy beginning between 18-22 weeks' gestation.
At 18-22 weeks, blinded CGM data will be reviewed to assess if participant has...もっと見る |
非介入Observational | 該当なし |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy | Composite endpoint of (1) neonatal complications of large for gestational age (LGA), shoulder dystocia (including humeral or clavicular fracture), elevated bilirubin requiring phototherapy, or neonatal intensive care unit (NICU) admission; or (2) maternal hypertensive disorder of pregnancy (HDP) . | Baseline to 45 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Composite of Neonatal Complications, Death, and Maternal Complications | * Composite of neonatal complications
* Individual maternal and neonatal complications
* Neonatal death | Baseline to 45 weeks |
Maternal age of 18 years and older
Singleton pregnancy
Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening
• Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available
HbA1c <6.5% (48 mmol/mol) since onset of pregnancy
• If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.
No prior history of gestational diabetes mellitus (GDM)
Able to read English or Spanish
Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
Planned termination of pregnancy or any indications of miscarriage
Prior gastric bypass surgery
Pregravid diabetes (type 1 or type 2)
Unwillingness/inability to wear CGM sensor
Unwillingness to attend routine antenatal obstetric appointments
Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening
• Topical and inhaled corticosteroids are acceptable
Use of insulin during the pregnancy prior to enrollment
Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
Deemed unable to participate for medical reasons identified by their physician
Additional Criteria for RCT Eligibility
- Screening CGM meeting study criteria for hyperglycemia: 5% to <25% time >140 mg/dL
- Randomization by 16 week 6 days of pregnancy
- No participation in a separate intervention trial.
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