Rachael Sood, NP-C, on FDA Clearing the First AID System for Type 1 Diabetes in Pregnancy: "We Need All Hands on Deck"

Managing type 1 diabetes during pregnancy presents one of the most demanding glycemic challenges in clinical medicine. Pregnancy-specific glucose targets are tighter than standard non-pregnant thresholds, with the recommended range narrows to roughly 63–140 mg/dL, compared to 70–180 mg/dL outside of pregnancy.¹ In addition, insulin requirements shift week to week as maternal weight and placental hormones evolve. More than 50% of patients with type 1 diabetes continue to experience suboptimal glycemic control even on existing therapies, placing both mother and fetus at risk for complications including abnormal fetal development, preterm delivery, and adverse neonatal outcomes.

On April 28, 2026, the FDA cleared Control-IQ+ automated insulin delivery (AID) technology from Tandem Diabetes Care for use in pregnancy complicated by type 1 diabetes, making the t:slim X2 and Tandem Mobi the first and only AID systems cleared for this indication in the US. The clearance is supported by results from the CIRCUIT trial, a multi-center, randomized controlled trial of 94 pregnant women with type 1 diabetes. The results, published in JAMA in October 2025, showed that participants using Control-IQ+ technology spent 12.6% more time, equivalent to 3 hours per day, in the pregnancy-specific glucose range than women receiving standard care. Glycemic improvements emerged within the first week of initiation and were sustained across all baseline HbA_1c ranges, prior therapy types, and stages of lung function severity.^1,2

Despite prior off-label use in pregnant patients, the absence of a formal indication had limited uptake among OB-GYNs and maternal-fetal medicine specialists unfamiliar with AID technology. The new clearance is expected to expand access and encourage multidisciplinary adoption. Rachael Sood, RN, MSN, APRN, NP-C, CDCES, diabetes nurse practitioner and founder of The Diabetes Collective, sat down with Patient Care Online to discuss what this clearance means for clinical practice, who stands to benefit most, and what primary care physicians need to know.

References:

1. Tandem Diabetes Care’s Control-IQ+ Automated Insulin Delivery Technology new FDA cleared for pregnancy in type 1 diabetes. Tandem Diabetes Care, Inc. News release. Published April 27, 2026. Accessed April 28 2026. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-cares-control-iq-automated-insulin-delivery
2. Donovan LE, Lemieux P, Dunlop AD, et al. Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy: The CIRCUIT Randomized Clinical Trial. JAMA. 2025;334:2176-2185. doi:10.1001/jama.2025.19578