Two groundbreaking clinical trials at UCSF are testing new ways to manage gestational diabetes, a condition where blood sugar rises too high during pregnancy. One trial is examining whether automated insulin delivery systems work better than standard IV insulin during labor and delivery. The other is comparing metformin, an oral medication, against injectable insulin to see which approach produces better outcomes for pregnant people and their babies. What Is Gestational Diabetes and Why Does It Matter During Pregnancy? Gestational diabetes develops when a pregnant person's body cannot regulate blood sugar effectively during pregnancy. Unlike type 1 or type 2 diabetes, it typically appears only during pregnancy and may resolve after delivery. However, the condition carries real risks for both mother and baby if left unmanaged, including complications during labor, larger birth weight, and increased risk of type 2 diabetes later in life. Currently, doctors manage blood sugar during labor and delivery using intravenous insulin, which requires constant monitoring and adjustment. The UCSF trials are testing whether newer approaches might offer better control, easier use, and improved satisfaction for pregnant people facing this complication. How Are These New Treatment Approaches Different From Current Care? The first UCSF trial focuses on automated insulin delivery (AID) systems, sometimes called artificial pancreas technology. These devices automatically adjust insulin doses based on real-time blood sugar readings, rather than requiring manual adjustments by medical staff. Researchers are enrolling eligible females ages 18 to 55 with type 1 diabetes to compare AID systems directly against the current standard of intravenous insulin during labor and delivery. The second trial, called DECIDE, takes a different approach by comparing two oral and injectable medication options. This pragmatic trial will enroll 1,572 pregnant individuals with gestational diabetes across 20 U.S. sites. Participants will be randomly assigned to either metformin, an oral medication taken by mouth, or injectable insulin. Researchers will follow participants and their children through delivery and up to two years after birth to assess safety, effectiveness, and patient preferences. What Questions Are These Trials Trying to Answer? The automated insulin delivery trial has three main research questions. First, researchers want to know whether babies born to mothers using AID systems have better blood sugar levels after birth compared to those whose mothers received IV insulin. Second, they are measuring whether pregnant people report higher satisfaction with birth when using automated systems. Third, they are examining whether blood sugar control metrics, particularly time-in-range (the percentage of time blood sugar stays in a healthy zone), improve with AID systems compared to standard care. The DECIDE trial focuses on whether metformin is not inferior to insulin in preventing serious pregnancy complications. The study will also evaluate whether both medications are equally safe for the pregnant person and the developing baby, and whether patient-reported factors like ease of use and barriers to taking medications differ between the two options. Steps to Understanding Your Gestational Diabetes Treatment Options - Know Your Diagnosis: If you are diagnosed with gestational diabetes, ask your doctor to explain your blood sugar readings and what target range your care team is aiming for during pregnancy and labor. - Discuss Medication Choices: Talk with your healthcare provider about whether metformin, insulin, or other medications are appropriate for your situation, and ask about the pros and cons of each option. - Ask About Clinical Trials: If you are pregnant with gestational diabetes, ask whether you might be eligible for research studies like those at UCSF that could offer access to newer treatment technologies or comparative information about medication options. - Plan for Labor Management: Work with your obstetric team to develop a clear plan for how your blood sugar will be managed during labor and delivery, including what monitoring will occur and what medications or devices will be used. - Arrange Postpartum Follow-Up: Schedule blood sugar screening after pregnancy, since gestational diabetes increases the risk of developing type 2 diabetes later in life. Who Is Leading This Research and When Will Results Be Available? The gestational diabetes research program at UCSF is led by Dr. Nasim Sobhani, MD, and her team. Both trials are actively enrolling participants in 2026. The DECIDE trial, being the larger of the two with 1,572 participants across multiple sites, will provide robust evidence about whether metformin could become a viable first-line treatment option for gestational diabetes, potentially offering pregnant people an oral medication alternative to injections. These trials represent a shift toward patient-centered research in pregnancy care. Rather than simply testing whether a treatment works, researchers are also measuring whether pregnant people find the treatment acceptable, easy to use, and satisfying. This approach recognizes that the best treatment is one that people can actually stick with and that fits into their lives during an already demanding time. If you are pregnant or planning pregnancy and have questions about gestational diabetes screening or management, speak with your obstetrician or midwife. If you are interested in participating in clinical research, ask whether you might be eligible for trials in your area or visit ResearchMatch to explore other pregnancy-related studies.
