CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Обзор

The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are: (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 high blood pressure issues for the mother during pregnancy.

Подробное описание

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 sensor data will be evaluated to determine if the following criterion is met: 5% to \<25% of values \>140 mg/dL

• An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days * Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation. * Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is \<6.5% (48 mmol/mol)

Вмешательства

• Другое 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 by site and by central CGM Resource Center for flagged cases. Participants not r
• Другое Usual Care Group
  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 ≥25% time \>140 mg/dL to determine if an early OGTT or glycemic management is r

Первичные конечные точки

• Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy [Срок оценки: Baseline to 45 weeks]

Вторичные конечные точки (1)

• Composite of Neonatal Complications, Death, and Maternal Complications [Срок оценки: Baseline to 45 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 8 центров

• University of Alabama at Birmingham — Birmingham
• University of Miami — Miami
• Emory University — Decatur
• IDC at Park Nicollet — Saint Louis Park
• Icahn School of Medicine at Mount Sinai — New York
• Cleveland Clinic — Cleveland
• Oregon Health & Science University — Portland
• University of Pennsylvania — Philadelphia

Великобритания · 2 центра

• Leeds Teaching Hospitals NHS Trust — Leeds
• Norfolk and Norwich University Hospitals NHS — Norwich

Идентификаторы

NCT: NCT06957028 · IMAGINE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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