No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
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At a Glance
Age
18 – 50
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
564 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for pregnant women with type 2 diabetes to see if using a continuous glucose monitor is better than checking blood sugar with fingersticks. Participants will monitor their blood sugar, complete surveys, and provide blood samples during the trial.
Are You a Good Fit for This Trial?
Must be takingInsulinOral hypoglycemic agents
You may be able to join if
I have been diagnosed with type 2 diabetes.
I am pregnant with a viable fetus between 6 to less than 23 weeks.
I am between 18 and 50 years old.
I take daily insulin injections or oral diabetes medications.
My hemoglobin A1c is 6.5% or greater.
You may not be able to join if
I cannot wear a continuous glucose monitor due to skin problems.
I am having twins or more.
My fetus has a major anomaly or multiple minor anomalies.
I plan to deliver outside of the study area.
I am already in another conflicting study.
I participated in this trial before.
I am unable to give my consent.
My doctor has advised against my participation.
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 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 monitor…
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
Trial Locations
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Eligibility Criteria
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 y…
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
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