Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes
Conditions
Keywords
Pregnancy, Intrapartum glycemic management, Neonatal hypoglycemia, Perinatal care, Diabetes in pregnancy
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.
Interventions
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.
OTHERIntravenous (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
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTPrincipal Investigator
PRINCIPAL_INVESTIGATORNasim Sobhani, MD
University of California, San Francisco
Outcome results
None listed