Diabetes Dialogue: Upcoming Research on Type 1 Diabetes in Pregnancy with Carol Levy, MD

Welcome back to Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives!

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, sit down with Carol Levy, MD, director of the Mount Sinai Diabetes Center and Type 1 Diabetes Clinical Research, to discuss the upcoming T1D Pregnancy and Me – or PRAM T1D – clinical study.

Levy explains that the motivation for the study arose from ongoing clinical uncertainty regarding optimal Continuous Glucose Monitor (CGM)-derived metrics during pregnancy, despite data from previous studies such as CONCEPTT that support CGM use. She underscores the limitations of existing guidelines, which were based primarily on fingerstick glucose targets, and notes that while targets like >70% time in range (TIR 63–140 mg/dL) are widely cited, there is insufficient evidence around how factors such as mean glucose, glycemic variability, and fasting values impact maternal and neonatal outcomes.

The study is designed to enroll at least 500 pregnant individuals with type 1 diabetes during their first trimester, with a goal of completing recruitment in under two years. Participants will be followed throughout pregnancy, and the study will collect both glycemic and pregnancy-related data through CGM and AID system uploads as well as patient-reported outcomes. Importantly, the study is intentionally designed to reflect real-world management—recruiting not only from major academic centers but also through self-enrollment from individuals across the U.S., including those receiving care in community settings. This decentralized model allows for broad inclusion across diverse geographies and practice types, helping address the gap in understanding how diabetes in pregnancy is managed outside tertiary care environments.

A key strength of the study lies in its technology-agnostic design. All CGM and insulin delivery devices are eligible, and the study aims to capture how current technologies—many of which are used off-label in pregnancy—are being applied in practice. By not restricting enrollment based on device type, the research team will be able to analyze patterns of use, self-management strategies, and variations in outcomes across platforms, laying the groundwork for future clinical guidance and product development.

Dr. Levy highlights that the study is also collecting data on quality of life, treatment satisfaction, and hypoglycemia-related fear, noting the real psychological burden that accompanies tight glucose management in pregnancy. These insights are expected to be critical in informing both clinician counseling and future research on patient-centered care. The data will be curated in partnership with the JAEB Center for Health Research, which will also provide statistical support for future analyses. The research team intends for the final dataset to become a resource for the broader clinical and scientific community.

Though the study’s current focus is on singleton pregnancies in individuals using any type of diabetes technology, Dr. Levy notes that the team has plans to adapt the protocol to account for emerging devices and future research questions, including expanded enrollment if supported by additional funding. She emphasizes the importance of generating robust, generalizable data to guide both clinical practice and the development of pregnancy-specific diabetes technologies—a long-neglected area in industry research.

The conversation concludes with a shared sense of urgency and optimism. As CGM and AID use continues to rise among individuals with type 1 diabetes, the need for pregnancy-specific data, tools, and targets becomes increasingly critical. Dr. Levy calls on endocrinologists, obstetricians, and maternal-fetal medicine specialists alike to engage with the study and help bridge the current evidence gaps. With enrollment already well underway, this initiative has the potential to transform care for pregnant individuals with type 1 diabetes by informing not only best practices but also product innovation and policy.

Relevant disclosures for Levy include Sequel, Eli Lilly and Company, Tandem Diabetes, and Dexcom. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.