MedTrace Logo

Automated Insulin for Management of Intrapartum Glycemia

NCT06883344 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Nasim Sobhani, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883344 on ClinicalTrials.gov