Tandem Diabetes Care announced that the U.S. Food and Drug Administration cleared its Control‑IQ+ automated insulin delivery system for use in pregnancy for people with type 1 diabetes. The clearance, effective April 27, 2026, applies to both the t:slim X2 and Tandem Mobi insulin delivery systems.
The approval is based on the CIRCUIT trial, published in the Journal of the American Medical Association in October 2025. In the study, participants using Control‑IQ experienced a 12.6% increase in time spent within the pregnancy‑specific glucose target range of 63 mg/dL–140 mg/dL, roughly three additional hours per day. Maternal and neonatal outcomes were comparable to the control group and trended more favorably in the Control‑IQ group.
This regulatory milestone makes Control‑IQ+ the first and only commercially available automated insulin delivery system in the United States cleared for use during pregnancy, positioning Tandem as a leader in a critical, underserved market. The expanded indication is expected to broaden the company’s customer base and increase demand for pumps and supplies, potentially boosting recurring revenue streams.
Tandem’s recent financial performance underscores the commercial impact of this approval. In Q4 2025, the company reported revenue of $290.4 million, up 15.1% year‑over‑year, and earnings per share of –$0.01 versus an estimate of –$0.05, a beat of $0.04. Guidance for 2026 projects worldwide sales of $1.065 billion to $1.085 billion, while the company notes headwinds from a transition to a pay‑as‑you‑go reimbursement model and direct international operations.
Management highlighted the clinical significance of the approval. Dr. Jordan Pinsker, Chief Medical Officer, said, “Glycaemic goals are tighter during pregnancy. The higher time in the pregnancy‑specific glucose range seen with Control‑IQ can help improve pregnancy outcomes.” Dr. Lois Donovan, principal investigator of the CIRCUIT trial, noted, “In the CIRCUIT trial, glycaemic improvements were found across all sites and baseline HbA1c ranges, regardless of whether an insulin pump or multiple daily insulin injections were used at enrolment.” She added, “Marked glycaemic improvements occurred within the first week of initiation of Control‑IQ that persisted for the duration of pregnancy.”
The FDA clearance, combined with Tandem’s strong Q4 results and forward guidance, signals confidence in the company’s ability to capture a new, high‑value patient segment while managing upcoming reimbursement challenges. The approval is expected to accelerate growth in the pregnancy market and reinforce Tandem’s position as a pioneer in automated insulin delivery technology.
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