Pilot Study of Intrapartum Insulin Pump Use: Feasibility, Efficacy and Safety

Optimal intrapartum glucose management remains an unresolved challenge in the care of pregnant individuals with pre-gestational diabetes, despite its critical importance to maternal and neonatal outcomes.1 Approximately 18 million women in the United States have diabetes mellitus2, and pregestational diabetes complicates 1-2% of all pregnancies3. Poor glycemic control during labor is associated with an increased risk of neonatal hypoglycemia, respiratory distress, hyperbilirubinemia, and dangerous maternal glycemic variability.1 However, best practices for intrapartum glucose management remain inadequately defined and warrant further investigation.4,5,6 Automated insulin delivery (AID) systems and modern continuous subcutaneous insulin infusion (CSII) technology now allow for precise glucose management and have transformed diabetes care, emerging as a new standard for glycemic management during pregnancy. Despite routine use in the antenatal period, these pumps are usually discontinued upon hospital admission for labor with transition to more traditional intravenous (IV) insulin infusions.7 This may cause glycemic instability, is labor-intensive, burdens both patients and clinical teams,4 and diminishes patient autonomy.8,9 Urgently addressing the gap in clinical evidence to guide CSII/AID use during labor could change clinical practice, optimize glucose management protocols during labor, and ultimately reduce preventable complications for both mother and baby.

Washington, DC provides an ideal environment to study innovations in intrapartum diabetes care. Diabetes prevalence reaches 19.7% in underserved wards10,11, much higher than the national rate of 11.6%. MedStar Health is a major regional network serving a broad and diverse patient population. Within this system, the MedStar Diabetes in Pregnancy Program delivers multidisciplinary care to hundreds of pregnant individuals with diabetes each year. With robust clinical infrastructure, strong community partnerships, and a focus on reducing barriers to care, our team is ideally positioned to evaluate CSII/AID therapy during labor in a real-world, high-risk population.

The overall objective of this pilot study is to evaluate the feasibility, safety, and acceptability of CSII during labor. This will provide foundational data to inform the design of a potentially practice and guidelines-changing multicenter randomized controlled trial (RCT). Our long-term goal is to determine whether CSII is a safe and effective alternative to IV insulin, the current standard of care, for intrapartum diabetes management. We hypothesize that use of insulin pumps in labor is safe, maintains glycemic control equivalent to or better than IV insulin, reduces neonatal hypoglycemia, and improves patient birth experience while reducing healthcare burden. To achieve this, we propose the following specific aims:

Specific Aim 1 Feasibility:[MM1.1] To assess the feasibility of intrapartum insulin pump management We will conduct a quasi-experimental, non-randomized design consisting of two arms: a prospectively enrolled cohort managed with CSII/AID during labor and a matched historical cohort managed with IV insulin. We will assess key feasibility metrics including insulin pump protocol creation and adherence, integration into clinical workflows, and recruitment and retention rates. We will evaluate preliminary effectiveness and safety by comparing maternal glycemic and neonatal outcomes between cohorts. These data will inform the design, protocol refinement, implementation strategies, and power calculations for a future multicenter trial.

Specific Aim 2 Stakeholder experiences: To characterize patient, provider, and nursing perspectives with intrapartum CSII/AID use.