Pregnant women with type 1 diabetes should be given “game-changing” automated insulin delivery, according to a new study.
Researchers at the University of East Anglia, UK, said hybrid closed-loop technology could help pregnant women better manage their blood sugars compared to traditional insulin pumps or multiple daily injections.
Lead researcher Professor Helen Murphy, from UEA’s 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.”
The team trialled hybrid closed loop (artificial pancreas), which comprises an algorithm that is uploaded onto a smartphone and which communicates with the traditional continuous glucose monitoring and insulin pump systems and adjusts insulin doses every 10-12 minutes according to blood sugar levels. It means it continuously responds to the changes in blood sugar levels throughout pregnancy.
The team compared this technology with the traditional continuous glucose monitoring and insulin systems, where women, who are supported by specialist diabetes maternity teams, have to make many daily decisions about insulin doses. The results are published in The New England Journal of Medicine.
They enrolled on to the study 124 pregnant women, aged 18-45, being looked after at nine NHS hospitals in England, Scotland, and Northern Ireland. All had type 1 diabetes and managed their condition with daily insulin therapy.
They took part in the study for about 24 weeks – from about 10-12 weeks’ pregnant until the end of their pregnancy – and half were randomly allocated to use the hybrid closed-loop technology, with the other half using the traditional insulin therapy of insulin pumps or multiple daily injection.
On average, pregnant women used the hybrid closed-loop technology for more than 95% of the time, gained 3.5 kg (7.7 lbs) less weight and were less likely to have blood pressure complications during pregnancy than the other cohort in the study.
They also had to attend fewer antenatal clinic appointments and fewer out-of-hours calls with maternity clinic teams, which, say the authors, suggests the technology is potentially time saving and more cost effective for NHS services.
In contrast with traditional insulin therapy methods, women who used the technology spent more time in the target range for pregnancy blood sugar levels – 68% compared with 56%, which is equivalent to an additional two-and-a-half to three hours every day throughout pregnancy.
It was also found to be safe during the first trimester, said Professor Murphy, adding that women’s blood sugar levels improved consistently, regardless of their age, their previous blood sugar levels or previous insulin therapy.
“We found that the technology helped to substantially reduce maternal blood sugars throughout pregnancy,” she said. “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.
“Compared to traditional insulin therapy methods, women who used the technology spent more time in the target range for pregnancy blood sugar levels – 68% vs 56%, which is equivalent to an additional two-and-a-half to three hours every day throughout pregnancy.”
She added: “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.”
The researchers caution that the study has some limitations, including that it was too small for a detailed examination of baby health outcomes, and that the results are specific to the CamAPS technology, so cannot be extrapolated to closed-loop systems, with higher blood sugar targets, that may not be applicable for use during pregnancy.
The study was presented at the European Association for the Study of Diabetes (EASD) meeting in Hamburg, Germany, which takes place from 2-6 October.
Hybrid Closed-Loop technology improved maternal glucose levels during pregnancy complicated by type 1 diabetes. The New England Journal of Medicine 5 October 2023
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