Automated Insulin for Management of Intrapartum Glycemia

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes (T1D); Pregnancy; Pre-Gestational Diabetes

• Registration Number: NCT06883344
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-21
• Study Start: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Known diagnosis of type 1 diabetes ≥ 1 year
• Current use of commercially available AID system ≥ 6 months
• Currently pregnant at ≥ 34 weeks
• Singleton pregnancy
• English- or Spanish-speaking

Exclusion Criteria

• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First neonatal glucose value	Within 2 hours of birth	A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).

Secondary Outcome Measures

Name	Time	Method
Birth Satisfaction Scale Revised (BSS-R) score	Within 2 weeks of delivery	The BSS-R is a 10-item, multi-dimensional, psychometric instrument that has been validated as a measure of birth satisfaction. This endpoint was selected to adequately assess patient perception of quality of care received and labor-related stress experienced.
CGM-derived glycemic parameters	From admission to labor/delivery unit to birth of infant	Glycemic parameters like time in range (TIR), time below range (TBR), and time above range (TAR) will be examined as markers of intrapartum glycemia

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States