Automated insulin delivery during labor for pregnant people with type 1 diabetes
Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Randomized Clinical Trial
This trial will test whether using an automated insulin delivery (AID) system during labor and delivery helps pregnant people with type 1 diabetes keep blood sugar in range, reduces newborn low blood sugar, and improves birth satisfaction compared with IV insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06883344 on ClinicalTrials.gov |
What this trial studies
This randomized trial will assign pregnant participants with type 1 diabetes to either continue an automated insulin delivery (AID) system or receive standard intravenous (IV) insulin for glucose management during labor and delivery. Investigators will compare neonatal glycemic outcomes, maternal time-in-range during labor, and patient-reported birth satisfaction between groups. Eligible participants are at least 34 weeks gestation, have a singleton pregnancy, and have used a commercial AID system since at least 28 weeks. The trial is conducted at the University of California, San Francisco and outcomes focus on intrapartum and immediate newborn glucose measures.
Who should consider this trial
Good fit: Pregnant people with type 1 diabetes at ≥34 weeks gestation who have used a commercially available AID system since at least 28 weeks, have a singleton pregnancy, and speak English or Spanish.
Not a fit: People planning a cesarean delivery, with multifetal gestation, not using an AID system since 28 weeks, taking medications that affect glucose metabolism, or with conditions preventing participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, AID use during labor could improve maternal glucose control, lower rates of newborn hypoglycemia, and increase birth satisfaction.
How similar studies have performed: Automated insulin delivery has improved time-in-range in pregnancy outside of labor, but randomized data on using AID during labor and delivery are limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Currently pregnant at ≥ 34 weeks * Known diagnosis of type 1 diabetes ≥ 1 year * Use of commercially available AID system since at least 28 weeks gestation * Singleton pregnancy * English- or Spanish-speaking Exclusion Criteria: * Multifetal gestation * Planned cesarean delivery * Use of medications known to interfere with glucose metabolism * Intrauterine fetal demise * Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Nasim Sobhani, MD — University of California, San Francisco
- Study coordinator: Principal Investigator
- Email: dappresearch@ucsf.edu
- Phone: (415) 307-9319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.