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New treatment option for Gestational Diabetes Mellitus in Pregnancy
Official title CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
ClinicalTrials.gov ID: NCT06957028
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- HbA1c \<6.5% (48 mmol/mol) since onset of pregnancy
You likely can't join if
- Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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 \ 140 mg/dL
- Randomization by 16 week 6 days of pregnancy
- No participation in a separate intervention trial.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Miami, Florida, United States
- Decatur, Georgia, United States
- Saint Louis Park, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Leeds, Leeds, United Kingdom
- Norwich, Norwich, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Miami, Florida, United States; Decatur, Georgia, United States; Saint Louis Park, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.