Smart insulin system improves glucose control for pregnant women with type 1 diabetes, according to ADA 2025 clinical trial findings

A new multicenter clinical study unveiled at the American Diabetes Association’s (ADA) 85th Scientific Sessions revealed that a hybrid closed-loop insulin delivery system helped pregnant women with type 1 diabetes achieve superior glucose control compared to standard care. The research, presented during the late-breaking poster session in Chicago on June 20, 2025, highlighted significant improvements in time spent within the pregnancy-specific glucose target range using the Tandem t:slim X2 insulin pump powered by Control-IQ Technology, alongside the Dexcom G6 continuous glucose monitor.

While this automated insulin delivery (AID) system is currently authorized for general population use, it has not been approved specifically for use during pregnancy. This latest trial could play a pivotal role in informing regulatory agencies and clinicians on expanding its application. A total of 91 participants were enrolled across 14 clinical sites in Canada and Australia, with researchers evaluating outcomes from early gestation through delivery.

Analysts and endocrinology specialists monitoring diabetes therapy innovation believe this study underscores a growing trend in favor of algorithm-driven insulin systems for high-risk populations, especially where tight glycemic control is essential.

How does hybrid closed-loop insulin delivery compare to standard insulin regimens during pregnancy?

Hybrid closed-loop systems automatically adjust insulin delivery in response to real-time blood glucose readings. In this study, patients in the HCL group used the Control-IQ system, which integrates a pump with embedded algorithms and a glucose sensor to maintain glucose within the optimal pregnancy target of 63–140 mg/dL (3.5–7.8 mmol/L). The control group followed standard regimens such as multiple daily injections or non-automated pumps, both used alongside CGM.

The randomized open-label trial began by week 16 of pregnancy. Participants in the HCL group were encouraged to keep their insulin pump in “sleep activity” mode at all times—a setting associated with tighter glycemic thresholds. This aimed to minimize risk and increase stability throughout the remaining pregnancy.

Trial results demonstrated that women in the automated insulin group spent three more hours per day within the target range compared to their counterparts on standard care. Time in target range was 12.5 percentage points higher, indicating a substantial improvement in maternal glucose management. Additionally, the HCL group spent 11.5% less time above the recommended threshold and just 1% more time below 63 mg/dL—a favorable tradeoff suggesting less risk of both hyperglycemia and hypoglycemia.

Why is glycemic control especially critical for women with type 1 diabetes during pregnancy?

Pregnant women with type 1 diabetes face elevated risks for miscarriage, congenital malformations, preeclampsia, and preterm delivery if glucose levels are not strictly controlled. The physiological changes during pregnancy often cause increased insulin resistance and erratic glucose fluctuations, making management particularly complex.

The ADA and global health authorities recommend a narrower glucose range during pregnancy than in non-pregnant populations. Yet despite advancements in monitoring and insulin formulation, many patients struggle to stay consistently within this threshold.

According to clinicians attending the ADA sessions, these findings represent one of the first data-driven validations of AID system safety and effectiveness in pregnancy, bridging an evidence gap that has slowed adoption in maternal care settings.

Lois Donovan, MD, FRCPC, lead investigator and professor at the University of Calgary’s Cumming School of Medicine, emphasized the need for clinical solutions tailored to the pregnancy population. “Our results reflect the importance of evolving automated insulin delivery to support those living with type 1 diabetes when they are pregnant or preparing for pregnancy,” she said.

What did the ADA 2025 session reveal about broader trends in smart insulin technologies?

The ADA’s 85th Scientific Sessions, held from June 20 to 23 in Chicago, drew thousands of healthcare professionals, diabetes researchers, and medical technology developers. The event featured hundreds of original research presentations spanning glycemic control, diagnostics, therapeutics, and metabolic innovations.

The late-breaking session that featured this trial also previewed additional data sets from diabetes-related smart device trials, artificial pancreas systems, and CGM adoption trends across age groups. Institutional attendees noted that automated insulin delivery solutions are gaining traction not just for patient convenience but for their clinical ability to reduce variability in chronic glucose exposure—one of the most significant drivers of complications in type 1 diabetes.

Industry observers said the expansion of closed-loop insulin platforms into pregnancy care would represent a logical step forward. While further FDA clearance is required for pregnancy-specific approval, several presenters suggested that real-world data from this study could support a formal indication extension.

Will automated insulin delivery be approved for pregnancy use in the near future?

Currently, no hybrid closed-loop systems hold formal regulatory approval for use during pregnancy, even though healthcare providers may offer them off-label under supervised clinical circumstances. Analysts expect that the favorable results from this study could encourage manufacturers like Tandem Diabetes Care and Dexcom to initiate regulatory dialogue with agencies in North America, Europe, and Australia.

The study also opens the door for evaluating outcomes at additional timepoints, such as labor and delivery. Researchers plan to assess how AID systems perform during childbirth, when hormonal and metabolic shifts intensify and glucose management becomes even more volatile.

Further investigation is also underway into nutritional variables collected during the trial using a diet-tracking app. This could provide deeper insights into how food intake interacts with automated insulin algorithms in pregnancy—especially as meal-related glucose spikes are notoriously difficult to control in this population.

Institutional sentiment remains broadly positive, with expectations that device manufacturers may pursue label expansion filings by 2026 if follow-up data confirms safety and outcome stability. Hospital systems and endocrinology clinics may also begin revising protocols based on these findings.

What is the future market impact of pregnancy-focused insulin automation systems?

From an industry perspective, pregnancy-focused insulin automation represents a high-value niche within the broader diabetes device ecosystem. Although relatively small in patient population, the clinical and economic implications of avoiding neonatal complications and maternal morbidity are significant.

Experts at ADA noted that insurers and health systems are increasingly motivated to support technology that reduces emergency interventions and neonatal intensive care usage—outcomes strongly correlated with poor glucose control during pregnancy. Automated insulin systems, if proven safe, could shift care away from reactive interventions toward proactive, algorithm-guided therapy.

Device makers such as Tandem Diabetes Care and CGM leaders like Dexcom may benefit from vertical expansion of their product lines into OB/GYN and maternal health markets, where reimbursement structures and provider education remain barriers. However, early-stage clinical endorsement, such as this trial, could help overcome institutional inertia.

As payer models move toward outcomes-based reimbursement and remote monitoring solutions, hybrid closed-loop systems are well-positioned to offer scalable, compliant, and patient-centered alternatives—particularly in underserved regions where endocrinology specialists are scarce.