Control-IQ+ Now FDA Cleared for Pregnancy in Type 1
Control-IQ+ Is Now FDA Cleared for Pregnancy in Type 1 Diabetes
For the first time, a commercially available automated insulin delivery system in the United States carries an indication for use during pregnancy. Here's what changed, what the study behind it found, and why it matters.
Posted June 2026 · Juicebox Podcast BlogIf you've ever managed type 1 diabetes through a pregnancy — or sat next to someone who has — you already know the problem this solves. Pregnancy doesn't just raise the stakes; it tightens the targets. The goal range shrinks to 63–140 mg/dL, insulin needs shift week to week, and until now, every automated insulin delivery system on the U.S. market was built around targets designed for people who aren't pregnant. Women were routinely told their algorithm wasn't cleared for pregnancy, leaving them to choose between using technology off-label or going back to doing everything by hand during the hardest stretch of diabetes management most of them will ever face.
That just changed. In late April, Tandem Diabetes Care announced that the FDA has cleared Control-IQ+ automated insulin delivery technology for use in pregnancy complicated by type 1 diabetes. The clearance covers both of Tandem's pumps — the t:slim X2 and the Tandem Mobi — making them the first and only commercially available AID systems in the United States cleared for use during pregnancy. One footnote worth knowing up front: the indication applies provided the connected CGM is also suitable for use in pregnancy.
The study behind the clearance
This wasn't a paperwork update. The expanded indication is built on the CIRCUIT trial, a multi-center randomized controlled study published in JAMA in October 2025. Participants were assigned either to a t:slim X2 with Control-IQ technology or to continue their existing therapy — multiple daily injections or a pump — alongside continuous glucose monitoring.
The headline result: from 16 weeks gestation through the end of pregnancy, the Control-IQ group spent 12.6% more time in the pregnancy glucose target range of 63–140 mg/dL. That works out to roughly three extra hours per day in range. Maternal and newborn outcomes were similar between the two groups overall, with the numbers leaning in favor of the Control-IQ users.
Two details from the trial stand out to me. First, the improvement showed up regardless of where people started — across every study site, across baseline A1c ranges, and whether participants came in on injections or a pump. Second, according to principal investigator Dr. Lois Donovan of the University of Calgary, the glycemic improvement appeared within the first week of starting Control-IQ and held for the rest of the pregnancy. That's not a slow ramp. That's the algorithm meeting the need almost immediately.
Dr. Pinsker's point is the whole story in five words. More time in the pregnancy-specific range is associated with better pregnancy outcomes — and an algorithm that's actually allowed to chase that range, all day and all night, is doing work that no exhausted pregnant person should have to do alone at 3 a.m.
Why this matters beyond the headline
I say this all the time: diabetes is timing and amount. Pregnancy is what happens when both of those variables start moving on you constantly — insulin resistance climbs through the trimesters, targets tighten, and the margin for error feels smaller because it is. Automation doesn't erase the need to understand your settings, your basal, your ratios. It never does. But a system that's been studied in pregnancy, against pregnancy targets, and cleared on that evidence gives pregnant women and their care teams something they've never had before: a sanctioned option instead of a workaround.
It also matters for the conversation in the exam room. Until now, plenty of women heard some version of “we can't recommend that during pregnancy.” Now there's an indication, a JAMA-published randomized trial, and a label to point to. That changes what's possible to ask for.
FDA clearance for use in pregnancy complicated by type 1 diabetes, on both the t:slim X2 and Tandem Mobi.
Multi-center randomized controlled trial published in JAMA, October 2025. Improvements appeared within the first week of use.
About three more hours per day in the 63–140 mg/dL pregnancy target range, from 16 weeks gestation to delivery.
Tandem is rolling out healthcare provider education on pregnancy and T1D, starting at the ADA Scientific Sessions in New Orleans this June.
If you're pregnant or planning to be
Talk to your care team first
This is news, not medical advice. If you're pregnant or planning a pregnancy with type 1 diabetes, bring this clearance to your endocrinologist and your maternal-fetal medicine team and ask whether Control-IQ+ fits your situation. Remember that the pregnancy indication requires a connected CGM that is also suitable for use in pregnancy, and the system is indicated for use with NovoLog or Humalog U-100 insulin.
And whichever path you take — automated or manual, pump or pens — the fundamentals don't change. Solid settings, honest carb awareness, and well-timed insulin are still the foundation everything else sits on. An algorithm amplifies good settings; it doesn't replace them.
One more thing worth saying plainly: for years, pregnant women with T1D have been some of the most under-served, hardest-working people in this entire community. They've managed tighter targets than anyone, with less technology support than everyone. A cleared, studied, on-label option won't make pregnancy with type 1 easy. But it moves the floor up — and that's exactly the kind of progress worth celebrating.
Want to learn more about Tandem's pumps and Control-IQ+? Use my link — bit.ly/4hyIrTn — it takes you to Tandem and lets them know the Juicebox Podcast sent you. Full safety information is at tandemdiabetes.com/safetyinfo.
Pregnancy with T1D is a marathon. Don't run it uninformed.
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