Currently, one in two babies born to mothers with T1D has complications related to high blood sugars, including premature birth, stillbirth, the need for intensive care after birth, higher than average birth weights, and higher than average rates of pre-eclampsia and Caesarean section for mothers. Despite all the advances in diabetes care over the past 40 years, these birth outcomes have not improved. This trial points to a new way to potentially prevent complications and save lives.
“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 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.”
The study, “CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial”, recruited 325 pregnant women with type 1 diabetes aged 18-40 who managed their condition with daily insulin therapy (insulin pumps or multiple daily injections). Half were randomly allocated to use a CGM device, and half to use the traditional monitoring method of testing blood derived from a pricked finger approximately four to eight times a day (as compared to the 288 glucose recordings a day from a CGM device). The device was worn for approximately 24 weeks (from 10-12 weeks until the end of their pregnancy).
Continuous glucose monitoring systems track blood sugar levels in real time throughout the day and night, enabling the user to take immediate action when faced with high or low blood sugars. This technology has the potential to transform the day-to-day management of diabetes but had not been previously tested in pregnancy.
Women in the CONCEPTT study using a CGM had better blood sugar levels on average, and spent an extra 100 minutes per day with blood sugar levels in the recommended target range in late pregnancy.
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.
“Women using insulin pumps and insulin injections benefitted equally, meaning our results are applicable to all pregnant women with type 1 diabetes. Although continuous monitoring is more expensive than standard glucose testing, there is potential for substantial healthcare savings,” said Professor Helen Murphy, co-principal investigator of CONCEPTT. “An admission to the neonatal intensive care unit is far more expensive than continuous glucose monitoring during pregnancy. These results should influence clinical practice so that all women with type 1 diabetes have the best possible chance of having a healthy baby.”
Dr. Denice Feig, co-principal investigator of the study, stated, “Women need to manage blood glucose levels very tightly in order to avoid pregnancy complications for their babies, but that can be very difficult to do. We have shown here, for the first time, that using continuous glucose monitoring leads to improved glucose control during pregnancy and a reduction in neonatal health complications.”
This international study was funded by JDRF, the leading organization funding type 1 diabetes (T1D) research, through the JDRF Canadian Clinical Trial Network—a partnership between JDRF Canada and FedDev Ontario, an agency of the Government of Canada. It was carried out by co-principal investigators Dr. Denice Feig at the Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto; and Professor Helen Murphy at Cambridge University NHS Foundations Trust, University of East Anglia and Kings College London. Central trial coordination was conducted at Clinical Trial Services/Centre for Mother, Infant, and Child Research at Sunnybrook Research Institute, Toronto, Ontario, and CGM data management and analysis was led by Jaeb Center for Health Research in Tampa, Florida.
Type 1 diabetes (T1D) is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas, called beta cells. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. Its onset has nothing to do with diet or lifestyle. There is nothing you can do to prevent T1D, and—at present—nothing you can do to get rid of it.
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.
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