Automated Insulin for Management of Intrapartum Glycemia

a study on Diabetes Diabetes Type 1 Pregnancy Gestational Diabetes

Summary

Eligibility
for females ages 18-55 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around
Principal Investigator
by Gladys (Sandy) Ramos
Headshot of Gladys (Sandy) Ramos
Gladys (Sandy) Ramos

Description

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.

Official Title

Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial

Keywords

Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes, Intrapartum glycemic management, Neonatal hypoglycemia, Perinatal care, Diabetes in pregnancy, Type 1 Diabetes Mellitus, Gestational Diabetes, Insemination, Artificial, Heterologous, Drug Delivery Systems, Insulin, Automated insulin delivery (AID) system, Intravenous (IV) insulin

Eligibility

You can join if…

Open to females ages 18-55

  • 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 CAN'T join 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

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92121 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSD

  • Gladys (Sandy) Ramos
    Clinical Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 57 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06883344
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated
Contact us about this trial