FDA clears Tandem's Control-IQ+ for use in pregnancy with type 1 diabetes

On April 24, 2026, the FDA cleared Tandem Diabetes Care's Control-IQ+ technology for use in pregnancy complicated by type 1 diabetes, under 510(k) number K260429.[1] Tandem announced the clearance three days later, on April 27.[3] It called its two pumps that run Control-IQ+, the t:slim X2 and Tandem Mobi, "the first and only commercially available AID systems cleared for use during pregnancy in the United States."[3]

What the FDA cleared

Control-IQ+ is software, not a pump.[2] The 510(k) summary describes it as a software-only device installed on a compatible insulin pump, where it adjusts insulin delivery based on readings from a compatible continuous glucose monitor (CGM) and on information the user enters.[2] The FDA files it under interoperable automated glycemic controllers, a Class II device type.[1][2] Tandem calls it automated insulin delivery, or AID, technology.[3]

The new sentence in the indications for use reads: "Control-IQ+ technology is intended for use in pregnancy complicated by Type 1 diabetes mellitus, provided the linked CGM system is suitable for use in pregnancy."[2] Tandem's release carries the same condition as a footnote.[3] Put plainly, the pregnancy indication applies only when the CGM paired with the pump is itself suitable for use during pregnancy.[2]

Everything else in the indications matches the predicate device, an earlier Control-IQ+ clearance numbered K250798.[2] That includes type 1 diabetes from age 2 and type 2 diabetes from age 18.[2] The software still requires a prescription.[2] The FDA received Tandem's submission on February 10, 2026, and found the device substantially equivalent to that predicate.[1][2] According to the summary, no new software testing was done for this submission, and no new human factors testing either; the support came from a clinical study.[2]

The CIRCUIT trial

That study was CIRCUIT.[2] The 510(k) summary says it enrolled 91 pregnant women aged 18 to 45 who had type 1 diabetes before their pregnancy, at 14 sites in Canada and Australia, all before 14 weeks of gestation.[2] Those assigned to Control-IQ technology started it before 16 weeks.[2] The primary measure was the share of each day that CGM glucose stayed between 63 and 140 mg/dL, from 16 weeks to 34 weeks 6 days of gestation.[2] The FDA record links the trial to ClinicalTrials.gov entry NCT04902378.[1]

In Tandem's description, the comparison group stayed on multiple daily insulin injections or on an insulin pump with a CGM.[3] Tandem reported that the Control-IQ group spent 12.6% more time in the 63-140 mg/dL pregnancy target range than the standard-therapy group, about 3 more hours a day, "from 16 weeks gestation to the end of pregnancy."[3] The company said maternal and newborn outcomes were similar in both groups overall "but favored those using Control-IQ."[3]

Tandem said the results were published in JAMA in October 2025.[3] We report the figures here as Tandem's release states them. We did not review the journal article itself, so we have left out any result the release does not give.

What this means for you

Tandem said the clearance covers Control-IQ+ on both of its insulin delivery systems, the t:slim X2 and Tandem Mobi.[3] The FDA's wording adds one condition: the linked CGM has to be suitable for use in pregnancy.[2] Control-IQ+ still requires a prescription.[2]

Tandem also said it planned training events and webinars on pregnancy and type 1 diabetes for healthcare providers, starting with a session at the American Diabetes Association's 2026 Scientific Sessions in New Orleans in June.[3]

Whether an AID system fits your pregnancy care, and which CGM would go with it, are not questions a news post can answer. Talk to your care team or pharmacist.