IMAGINE

Investigating Continuous Glucose Monitoring in Pregnant Women

Recruiting
18 years or above
Female
Phase N/A
6000 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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)

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gestational Diabetes Mellitus in Pregnancy
  • Age: 18 years or above
  • Gender: Female

Inclusion Criteria

  1. Maternal age of 18 years and older
  2. Singleton pregnancy
  3. 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

  4. 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.

  5. No prior history of gestational diabetes mellitus (GDM)
  6. Able to read English or Spanish

Exclusion Criteria

  1. Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
  2. Planned termination of pregnancy or any indications of miscarriage
  3. Prior gastric bypass surgery
  4. Pregravid diabetes (type 1 or type 2)
  5. Unwillingness/inability to wear CGM sensor
  6. Unwillingness to attend routine antenatal obstetric appointments
  7. 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

  8. Use of insulin during the pregnancy prior to enrollment
  9. 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
  10. Deemed unable to participate for medical reasons identified by their physician

Additional Criteria for RCT Eligibility

  1. Screening CGM meeting study criteria for hyperglycemia: 5% to <25% time >140 mg/dL
  2. Randomization by 16 week 6 days of pregnancy
  3. No participation in a separate intervention trial.

This study investigates the use of continuous glucose monitoring (CGM) in pregnant women. It focuses on managing high blood sugar levels during early pregnancy.

The study evaluates potential effects on the baby and the mother, including baby's size, shoulder injuries, and mother's blood pressure during pregnancy.

  • Who can participate: Pregnant women aged 18 and older with a single pregnancy and gestational age up to 14 weeks and 6 days, with no history of gestational diabetes, can participate.
  • Study details: Participants will use a continuous glucose monitor to track blood sugar levels.
Updated on 23 Dec 2025. Study ID: 25-0608

Find a site

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Please provide your preferred way of contact
Other language

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center