Automated Insulin for Management of Intrapartum Glycemia (AIMING)

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Type 1 Diabetes (T1D)

Pre-Gestational Diabetes

Pregnancy

Treatments

Other: Intravenous (IV) insulin

Device: Automated insulin delivery (AID) system

Study type

Interventional

Funder types

Other

Identifiers

NCT06883344

25-43619

Details and patient eligibility

About

The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are

What are the neonatal glycemic outcomes with use of AID systems during labor/delivery?
Do patients report higher birth satisfaction with use of AID systems during labor/delivery?
Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery?

Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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