Automated Insulin for Management of Intrapartum Glycemia

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Francisco
Study ID
NCT06883344
Status
Recruiting
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Conditions

  • Pre-Gestational Diabetes
  • Pregnancy
  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Automated insulin delivery (AID) system — DEVICE
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intravenous (IV) insulin
  • Experimental: Automated insulin delivery (AID) system

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92121
CORI Study Team
[email protected]
858-249-5985
Gladys (Sandy) Ramos (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Nasim Sobhani
[email protected]
415-307-9319
Ivonne Verduzco (SUB_INVESTIGATOR)

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