Rachel Sood, NP-C, CDCES, on the clinical impact of FDA-cleared AID technology in pregnancy

The April 27, 2026, expanded FDA clearance of Tandem Diabetes Care’s Control-IQ+ automated insulin delivery (AID) technology made it the first and only commercially available AID system in the United States cleared for use during pregnancy. While clinicians have previously utilized these systems, the official regulatory stamp provides the evidence-based validation necessary to move the needle for women’s health, according to Rachel Sood, RN, MSN, APRN, NP-C, CDCES, Diabetes nurse practitioner; Founder, The Diabetes Collective.

In this video interview, courtesy of our sister publication, Patient Care Online, Sood discussed how this clearance, supported by the 2025 CIRCUIT trial, addresses the unique challenges of achieving tight glycemic targets.

Validation through the CIRCUIT trial

The CIRCUIT trial demonstrated that participants using the Control-IQ+ algorithm experienced a 12.6% (P < .001) increase in time spent within the pregnancy-specific glucose range of 63–140 mg/dL. This improvement equates to approximately 3 hours more per day in target compared to standard therapy. Sood noted that while the system was accessible prior to this clearance, the published data and FDA recognition eliminate clinical hesitancy.

“Now the proof is in the pudding. It's in writing. We've got the data,” Sood stated. She emphasized that the evidence from nearly 100 patients should encourage more clinicians to “jump on board” with offering these systems to pregnant patients.

Meeting tighter glycemic targets

Managing T1D in pregnancy requires significantly lower glucose ranges than those required for non-pregnant individuals. While the standard target range is typically 70 to 180 mg/dL, pregnancy demands a shift to the mid-60s up to 140 mg/dL. Sood explained that achieving these targets is exceptionally difficult with multiple daily injections, especially as insulin needs naturally increase during pregnancy.

“We want those targets to be tighter. So any way that ob-gyns, midwives, or any specialty for that matter can support this, they need to know these glucose ranges should be tighter,” Sood noted. Specialized AID systems help achieve these specialized targets, creating a safe environment for fetal growth while reducing the burden on the mother.

The multidisciplinary approach

Sood highlighted that while OB-GYNs manage a wide array of clinical responsibilities, T1D in pregnancy is a specialized situation that often requires a multidisciplinary team. The clearance of the Tandem Mobi and t:slim X2 systems for this indication serves as a tool for collaboration between obstetricians and diabetes specialists.

“Ob-gyn specialists—whether it's a physician, PA, or nurse practitioner—need to know we have been using this system during pregnancy. This is not anything new,” Sood explained. She encouraged clinicians to utilize resources like CDCES and diabetologists to support patients through shifting insulin needs, ensuring that technology and expertise work together to help mothers achieve these rigorous target ranges.

Overall, Sood stated of the FDA clearance:
“I'm so excited. I'm thrilled because this is just another little stick in the belt that, ‘hey, we're doing things and moving the needle for women's health.’”

References:

1. Fitch J. FDA clears Control-IQ+AID technology for use in pregnancy complicated by type 1 diabetes. Contemporary OB/GYN. Published April 27, 2026. Accessed April 28, 2026. https://www.contemporaryobgyn.net/view/fda-clears-control-iq-automated-insulin-delivery-technology-for-use-in-pregnancy
2. 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