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JDRF-funded researchers have announced that pregnant women living with type 1 diabetes who used a continuous glucose monitor, or CGM, during their pregnancy in a major trial had better blood glucose control and healthier babies.

The international trial, named CONCEPTT, is the first study to show the benefits of CGM use on non-glycaemic health outcomes during pregnancy.

Pregnancy and CGM

Why did they do this research?

Women living with type 1 diabetes have to tightly control their blood glucose levels to ensure a safe and healthy pregnancy.

High blood glucose levels during pregnancy increase the risk of complications. Managing blood glucose levels (BGL) during pregnancy however is difficult because the body’s insulin requirements and insulin absorption can vary greatly day-to-day.

Researchers decided to test whether using a CGM during pregnancy could help mothers to manage their blood glucose levels, and lead to better health outcomes for their babies.

What did they do?

The team recruited 215 pregnant women from six countries, including the UK, Canada, Spain and Italy. Half of the women used a CGM in conjunction with their insulin pump or multiple daily insulin injections, and the rest of the women continued their existing management, without a CGM.

The women attended check-ups throughout their pregnancy to have their HbA1c and time spent in the recommended BGL range monitored. The team then analysed the health outcomes of the babies born.

What did they find?

Pregnant women from the CGM group had reduced HbA1c and spent an average of 100 minutes longer per day in the target glucose range than those not using a CGM.

These improved outcomes for expecting women were accompanied by substantial reductions in newborn complications. The number of babies being born larger than average was reduced (53 percent vs. 69 percent); the number of babies admitted to intensive care for more than 24 hours decreased (27 percent vs. 43 percent); and the number of babies born with low blood sugar levels decreased (15 percent vs. 28 percent). On average, babies whose mothers had used the continuous glucose monitoring device also left hospital one day earlier than babies whose mothers used traditional monitoring (3.1 vs. 4 days). They also had half as many neonatal intensive care unit admissions over 24 hours. Overall, for every six mothers treated, one large birthweight baby and one neonatal intensive care unit admission were prevented.

Professor Helen Murphy, from the research team, said:

“The benefit of having an international trial is that these results are important to women with type 1 diabetes across all countries.”

What does this mean for type 1?

These findings are encouraging news for women living with type 1 diabetes, as they indicate that CGM use can improve care during pregnancy, and help mothers to deliver healthy babies. Prof. Murphy said, “We would recommend that CGM be offered to all pregnant women with type 1 diabetes during the first trimester.”

“JDRF is proud to have supported this multinational trial that shows that the use of continuous glucose monitors during pregnancy has positive clinical outcomes for both mother and baby, across all countries where the study took place. This study will serve as a catalyst for improved access to life-saving CGM technology worldwide,” said Derek Rapp, JDRF International President and CEO. “We hope that these results will help people with type 1 diabetes to be confident in their decision to have children and help them make informed choices with their doctors about care.”

What’s the next step?

The trial indicated that using a CGM during pregnancy was broadly beneficial, whether on a pump or multiple daily injections. The team have now indicated that they would like to have a closer look at the data from the women who didn’t see as much of a benefit from the CGM, and explore if they might benefit more from other technology, such as closed-loop systems.

You can read the full study and results which are published in esteemed scientific journal, The Lancet.

 

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