Automated Insulin for Management of Intrapartum Glycemia

NCT06883344 | Recruiting FDA Device

• 1 other identifier: 25-43619
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• First neonatal glucose value

  A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).

  Within 2 hours of birth

Secondary Outcomes (2)

• Birth Satisfaction Scale Revised (BSS-R) score

  Within 2 weeks of delivery

• CGM-derived glycemic parameters

  From admission to labor/delivery unit to birth of infant

Study Arms (2)

Intravenous (IV) insulin

ACTIVE COMPARATOR

Other: Intravenous (IV) insulin

Automated insulin delivery (AID) system

EXPERIMENTAL

Device: Automated insulin delivery (AID) system

Interventions

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.

Intravenous (IV) insulin

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.

Automated insulin delivery (AID) system

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes, Gestational

Interventions

Insemination, Artificial, Heterologous; Drug Delivery Systems; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Drug Therapy; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nasim Sobhani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

(415) 307-9319; dappresearch@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)