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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intravenous (IV) insulin
  • Other: 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.
Experimental
Automated insulin delivery (AID) system
  • Device: 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.

Recruiting Locations

University of California, Los Angeles
Los Angeles, California 90095
Contact:
Dana Levine-Lopez
310-267-4331
ictu@mednet.ucla.edu

University of California, San Diego
San Diego, California 92121
Contact:
CORI Study Team
858-249-5985
CORIstudyteam@health.ucsd.edu

University of California, San Francisco
San Francisco, California 94143
Contact:
Nasim Sobhani
415-307-9319
dappresearch@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

DAPP Principal Investigator
(415) 307-9319
dappresearch@ucsf.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.