Hybrid closed-loop technology effectively helped women stay in target glucose range for longer compared to standard of care
CHICAGO, June 20, 2025 /PRNewswire/ — A new study shows pregnant women with type 1 diabetes stayed in the target blood glucose (blood sugar) range for pregnancy more often with an automated insulin delivery (AID) system (Control-IQ Technology) that is currently available for use—but not approved in pregnancy—compared to standard insulin delivery with injections or open-loop insulin pump therapy (non-automated) with continuous glucose monitoring (CGM). The results will be presented as a late-breaking poster at the 85th Scientific Sessions of the American Association® (ADA) in Chicago.
Managing blood glucose levels before, during, and after pregnancy is crucial to minimize risks associated with type 1 diabetes. A glucose range of 63–140 mg/dL (3.5–7.8 mmol/L) is recommended for optimal health results, but these targets can be challenging to achieve. As a result, associated risks of type 1 diabetes in pregnancy include increased chances of miscarriage, birth defects, preeclampsia, among others.
In a multicenter, open-label trial that began in early pregnancy and continued for the remainder of the pregnancy, researchers evaluated the impact of a hybrid closed-loop (HCL) insulin therapy treatment regimen, whereby an insulin pump (Tandem t:slim X2) uses an embedded control algorithm (Control-IQ Technology) to adjust insulin delivery based on real-time glucose (Dexcom G6 CGM) monitor readings, on pregnant women with type 1 diabetes and early pregnancy A1C levels of 6.2%–10%. A total of 91 women across 14 different sites in Canada and Australia were randomized to start HCL therapy by 16 weeks gestation or to continue their pregnancies with standard insulin injections or an insulin pump that was not automated, along with CGM. Participants were recommended to use the lowest target range (sleep activity) throughout the day and night.
Results from the study revealed that participants who used the HCL technology spent a longer portion of their day—three hours on average—in the pregnancy target glucose range than the standards of care group. Time spent in the target range was 12.5% age points lower among the standard care group. Further, for the group using automation, 11.5% less time was spent above range (95% CI 8.3,14.5) and 1% age points less time was spent below 63 mg/dL (95%CI 0.5,1.5), reflecting a more stable management of glucose levels.
“Managing glucose levels during pregnancy with type 1 diabetes is of critical importance for optimal health in both mother and child,” said Lois Donovan, MD, FRCPC, clinical professor at the University of Calgary AB Canada in the Cumming School of Medicine, Department of Medicine, Division of Endocrinology and Metabolism, Department of Obstetrics and Gynecology and lead presenter of the study. “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.”
Additional research will assess nutritional data collected concurrently during the trial via a nutrition app and evaluate use of this system at time of labor and delivery.
Research presentation details:
Dr. Donovan will present the findings at the following late-breaking poster session:
- Late Breaking Poster Session
- Session: Sunday June 22, 12:30 – 1:30 pm CT and Monday, and
- ePoster Theater – Emerging Technologies to Access Glycemia Across the Spectrum of Diabetes
- June 23, 2025 from 12:30 – 1:30 pm CT in the ePoster Theater A
About the ADA’s Scientific Sessions
The ADA’s 85th Scientific Sessions, the world’s largest scientific meeting focused on diabetes research, prevention, and care, will be held in Chicago, IL, on June 20–23. Thousands of leading physicians, scientists, and health care professionals from around the world are expected to convene both in person and virtually to unveil cutting-edge research, treatment recommendations, and advances toward a cure for diabetes. Attendees will receive exclusive access to thousands of original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Join the Scientific Sessions conversation on social media using #ADASciSessions.
About the American Diabetes Association
The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to end diabetes and helping people thrive. This year, the ADA celebrates 85 years of driving discovery and research to prevent, manage, treat, and ultimately cure—and we’re not stopping. There are 136 million Americans living with diabetes or prediabetes. Through advocacy, program development, and education, we’re fighting for them all. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (800-342-2383). Join us in the fight on Facebook (American Diabetes Association), Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn (American Diabetes Association), and Instagram (@AmDiabetesAssn). To learn more about how we are advocating for everyone affected by diabetes, visit us on X (@AmDiabetesAssn).
Media Contact: Mimi Carmody, [email protected]
SOURCE American Diabetes Association
