The study showed that pregnant women with type 1 diabetes stayed in the target glucose range for pregnancy more with the Tandem t:slim X2 automated insulin delivery system with Control-IQ technology compared to standard insulin delivery with injections or open-loop, non-automated insulin pump therapy with continuous glucose monitoring (CGM). Tandem’s technology is available for use in the U.S. but not approved for use in pregnancy.
Investigators plan to share findings from the study at the American Diabetes Association’s 85th Scientific Sessions in Chicago.
According to an ADA news release, managing blood glucose before, during and after pregnancy proves crucial to minimizing diabetes risks. Researchers recently called for more studies of automated insulin delivery during pregnancy. This multicenter, open-label trial 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. This regimen featured the t:slim X2 using its Control-IQ algorithm to adjust insulin delivery based on real-time Dexcom G6 CGM readings. The study evaluated 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 therapy by 16 weeks gestation or continue their standard injections or open-loop pump use. Investigators recommended that participants use the lowest target range (sleep activity) throughout the day and night.
Results showed that participants using the Tandem technology spent a longer portion of the day (three hours on average) in the target range compared to the standard of care. Time spent in target range landed 12.5% lower in the standard of care group. For those using automation, they spent 11.5% less time above range. Investigators say this reflects 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 Dr. Lois Donovan, 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.”
