Recruiting

AID vs. IV Insulin

Sponsor:

UCLA

Code:

NCT06883344

Conditions

Type 1 Diabetes (T1D)

Pregnancy

Pre-Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Automated insulin delivery (AID) system

Intravenous (IV) insulin

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes (T1D)

Pregnancy

Pre-Gestational Diabetes

Study ID

NCT06883344

Start date

Dec 5, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intravenous (IV) insulin

experimental: Automated insulin delivery (AID) system

Interventions

Automated insulin delivery (AID) system

An AID system incorporates data from a continuous glucose monitor (CGM) to automatically adjust the amount of insulin delivered by an insulin pump via an algorithm that incorporates multiple factors, including predicted glucose level in the next 30-60 minutes, target glucose level, and recent insulin delivery.

Intravenous (IV) insulin

Variable rate IV insulin infusions are used in most labor/delivery units as the standard of care for glycemic management for pregnant people with T1D. A continuous rate of IV insulin is infused, with manual rate adjustments made based on current glucose level and hospital-specific protocols.

Primary outcome measure

  • First neonatal glucose value [ Time Frame: Within 2 hours of birth ]

Central Contacts and Locations

Central contacts

DAPP Principal Investigator

(415) 307-9319dappresearch@ucsf.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Dana Levine-Lopez

310-267-4331ictu@mednet.ucla.edu

Principal Investigator:

Christina Han

University of California, San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

CORI Study Team

858-249-5985CORIstudyteam@health.ucsd.edu

Principal Investigator:

Gladys (Sandy) Ramos

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Nasim Sobhani

415-307-9319dappresearch@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Pregnancy
  • Intrapartum glycemic management
  • Neonatal hypoglycemia
  • Perinatal care
  • Diabetes in pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-13.