CGM for Management of Type 2 Diabetes in Pregnancy (NCT06628453) | Clinical Trial Compass
RecruitingNot Applicable
CGM for Management of Type 2 Diabetes in Pregnancy
United States564 participantsStarted 2025-04-08
Plain-language summary
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are:
1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose?
2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose?
3. What other factors increase the risk of maternal and infant complications?
Participants will:
1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery
2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis
3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits
4. Have umbilical cord blood collected at delivery for analysis
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater
* Pregnant with viable fetus at 6 to less than 23 weeks gestation
* Maternal age 18-50 years old
Exclusion Criteria:
* Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions
* Multiple gestation
* Major fetal anomaly or two or more minor fetal anomalies
* Planned delivery outside study consortium
* Participating in another conflicting interventional study
* Participation in this trial in a previous pregnancy
* Patient unable to consent
* Physician refusal for other reasons
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time in Range (TIR) at 34 weeks gestation
Timeframe: 33 to 35 weeks gestation
2
Composite Neonatal Morbidity
Timeframe: From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life