No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Screening
Participants needed
6,000 (estimated)
Sponsor
Jaeb Center for Health Research · Other
Who this trial is looking for
This trial is looking for pregnant women to use a continuous glucose monitor to help detect and manage high blood sugar early in pregnancy. Participants will be monitored to ensure their health and the baby's health during the study.
Are You a Good Fit for This Trial?
Must not be takingMetforminGLP-1 medication
You may be able to join if
I am at least 18 years old
I am pregnant with one baby
I am up to 14 weeks and 6 days pregnant
I have an HbA1c less than 6.5%
I have never had gestational diabetes
I can read English or Spanish
You may not be able to join if
I have signs of abnormal fetal or placental development
I am planning to terminate my pregnancy
I have had gastric bypass surgery
I have diabetes before getting pregnant
I cannot wear the CGM sensor
I cannot attend regular obstetric appointments
I have used corticosteroids that can raise blood sugar in the last week
I have used insulin during my pregnancy before enrolling
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 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.
Trial Locations
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Status
Eligibility Criteria
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…
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.
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