Hybrid closed-loop system for pregnant women with type 1 diabetes during pregnancy
Researchers recommend improved insulin delivery system should be available for all pregnant women with type 1 diabetes.
Newly improved insulin delivery via a hybrid closed-loop system should be made available to all women with type 1 diabetes during pregnancy, according to a recently published report.
The hybrid closed-loop system can improve control of blood glucose levels compared to insulin pumps and multiple daily injections, study authors said.
The results of the study were recently published in The New England Journal of Medicine and presented at the European Association for the Study of Diabetes (EASD) conference. The research was funded by a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).
Despite better systems for monitoring blood sugars and delivering insulin, hormonal changes during pregnancy, mean that most women struggle to reach the recommended blood sugar targets.
Therefore, complications related to having type 1 diabetes during pregnancy are more common, affecting one in every two newborn babies.
For the baby, these include premature birth, need for intensive care after birth, and being too large at birth, which increases the lifelong risk of overweight and obesity. Low blood sugars, excess weight gain, and high blood pressure during pregnancy are common amongst mothers.
Researchers trialled a technology known as hybrid closed-loop, or artificial pancreas.
The technology consists of an algorithm based on a smartphone and communicates with the traditional continuous glucose monitoring and insulin pump systems.
The system adjusts insulin doses every 10-12 minutes according to blood sugar levels, meaning that it continuously responds to the persistent changes in blood sugar levels throughout pregnancy.
The study involved 124 pregnant women with type 1 diabetes aged 18-45 years who managed their condition with daily insulin treatment. Half were randomly allocated to use the hybrid closed-loop technology, and half to use the traditional insulin therapy (insulin pumps or multiple daily injection methods).
Results for the study were recorded over approximately 24 weeks (from 10-12 weeks) until the end of pregnancy. The study took place in nine NHS hospitals in England, Scotland, and Northern Ireland, supported by the Norwich Clinical Trials Unit and the Jaeb Center for Health Research.
On average, pregnant women used the Hybrid Closed-Loop technology for more than 95% of the time. Using the technology helped to substantially reduce maternal blood sugars throughout pregnancy.
Lead researcher Prof Helen Murphy, from University of East Anglia Norwich Medical School, said: “Despite better systems for monitoring blood sugars and delivering insulin, altered eating behaviours and hormonal changes during pregnancy, mean that most women struggle to reach the recommended blood sugar targets.
“This means that complications related to having type 1 diabetes during pregnancy are widespread, affecting one in every two new-born babies.
“For the baby, these include premature birth, need for intensive care after birth, and being too large at birth, which increases the lifelong risk of overweight and obesity. Low blood sugars, excess weight gain, and high blood pressure during pregnancy are common amongst mothers.
“We wanted to investigate how automated insulin delivery could help.”
“For a long time, there has been limited progress in improving blood sugars for women with type 1 diabetes, so we’re really excited that our study offers a new option to help pregnant women manage their diabetes.”
“This technology is game changing, in that it will allow more women to have safer, healthier, more enjoyable pregnancies, with potential for lifelong benefits for their babies.”
Prof Eleanor Scott, of University of Leeds, said: “This is the good news that pregnant women with type 1 diabetes and NHS maternity services have been waiting for. It is great to see advances in diabetes technology come to fruition and deliver such improvements for pregnancy. Having recently successfully implemented continuous glucose monitoring uniformly across the NHS in England to improve mother and baby outcomes for pregnant women with type 1 diabetes, we are now well positioned for a similar roll out of hybrid closed loop to improve the situation further.”
Researchers noted some limitations to the study, including that the research was too small for a detailed examination of baby health outcomes, and that their results are specific to the CamAPS technology, so cannot be compared to other closed-loop systems, with higher blood sugar targets, that may not be applicable for use during pregnancy.
Nina Willer, who participated in the study, said: “Since starting on hybrid closed-loop and receiving the incredible support throughout my pregnancy I have felt so much more confident in myself and engaged in my diabetes.
“A couple of weeks after starting on hybrid closed-loop I was speaking to my mum about it and she burst into tears with joy. She said she has been praying every day for 17 years for a cure, and this is our cure. I definitely feel the same. This is absolutely life-changing, not just for me, but for my children. I am more present, I have more time to play and engage and less time saying ‘hang on, mummy needs a snack’. My husband says he can sleep safe in the knowledge I will wake up the next morning and my mum can finally exhale.
“I still have to think about my diabetes, but for once it is not at the forefront of my mind all day every day. For me it is like being on autopilot. I am very much in control, but I can relax and enjoy my day while the app does all the hard work for me.
“I am forever grateful for the care I received and the technology that was made available to me, and excited for the future of diabetes!”
Read the report in New England Journal of Medicine
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