Research published in theNew England Journal of Medicinetoday details the experiences of the first 16 women with Type 1 diabetes to successfully use an “artificial pancreas” throughout their pregnancy and during childbirth.
Momentum is building around the development of the artificial pancreas for people with Type 1 diabetes: a system that continuously monitors blood glucose levels, calculates the right amount of insulin required (through a device such as a tablet or mobile phone), and automatically delivers insulin through a pump.
Potential to transform the treatment of Type 1 diabetes
The technology has the potential to transform the treatment of Type 1 diabetes, especially during pregnancy. Controlling blood glucose levels is a daily challenge for people with Type 1 diabetes and is particularly crucial during pregnancy. If the condition isn’t managed properly, it can increase the risk of complications such as premature birth, large babies, admission to neonatal care units, stillbirth and infant mortality. National surveys show that one in two babies suffer complications related to Type 1 diabetes in the mother.
This study, funded by Diabetes UK and the National Institute of Health Research (NIHR) and carried out by Professor Helen Murphy at the University of East Anglia and Dr Zoe Stewart at the Institute of Metabolic Science, University of Cambridge, found that the artificial pancreas was associated with a 25 per cent relative improvement in glucose control compared with the current best available treatment – a continuous glucose monitor and an insulin pump.
“Better glucose control”
Dr Zoe Stewart, the lead author on the study, said: “Managing Type 1 diabetes in pregnancy can be really difficult. Hormonal changes that occur in pregnancy make it difficult to predict the best insulin doses for each woman. The artificial pancreas automates the insulin delivery giving better glucose control than we can achieve with current available treatments. We are so pleased that this technology is closer to being a reality for women with Type 1 diabetes that want to have a child.”
Laura Carver (pictured), 28, from Wymondham, Norfolk, was asked by her diabetes nurse a few weeks into her pregnancy if she would be interested in taking part in the trial.
“Initially I wasn’t keen on the idea,” admits Laura. “I had been diagnosed with Type 1 diabetes when I was 18-months-old and thought I was more than capable of managing it by myself. But I had suffered a miscarriage the previous Christmas and when I spoke to my husband and parents about the study they felt it was a good opportunity. The researchers discussed the study with me at length and that helped to reassure me.”
First of all Laura and her husband, Gordon, had to get trained up on the equipment.
“It was all new to me, because I hadn’t even used an insulin pump before – I’d been used to injecting myself with insulin up to six times a day,” said Laura.
Laura says her blood glucose control improved dramatically during the study. “I noticed that my blood glucose levels were within target range for much more of the time after I entered the study. I did have to carry the equipment around with me everywhere but that felt like a small price to pay to make sure me and the baby were healthy.”
However, things didn’t run entirely smoothly and, unrelated to the artificial pancreas, Laura ended up developing pre-eclampsia and had to have an emergency C section six weeks before her due date.
But the birth was relatively straightforward, and Laura and Gordon are now parents to Sonny, an 11-month-old happy and healthy baby boy.
Laura said: “I was able to keep some of the equipment for about a month after the birth and then I had to hand it back. To be honest it felt like I was losing a limb.”
Luckily Laura hasn’t had to go back to the injections. Instead she has got funding for a pump.
“Being part of this study took a bit of the fear away”
“The whole experience has given me hope and confidence if I was to ever have another baby. The miscarriage was very, very hard and I blamed myself and worried it would happen again. Being part of this study took a bit of the fear away. Certainly if this technology was available I wouldn’t hesitate in using it again.”
Dr Elizabeth Robertson, Director of Research at Diabetes UK, said: “Artificial pancreas technology has the potential to transform the treatment of Type 1 diabetes, and could be particularly pivotal for women during pregnancy who often struggle with managing their blood glucose levels. This study represents a real breakthrough in helping women to take control of their condition, and we’re very excited about the direction this research is moving.
“Diabetes UK have been investing in the development of the artificial pancreas since 1977 when we bought the first machine in the UK – which was the size of a filing cabinet. Now we’re watching people use tablets or mobile phones, and it’s an incredible achievement. In the meantime anyone with Type 1 diabetes who is planning on getting pregnant now should speak to their healthcare professional to get the help and support they need.”
The study was funded by Diabetes UK, the NIHR, the Gates Cambridge Trust, and Jean Hailes for Women’s Health Australia.
This study builds on previous work by the Cambridge team that demonstrated that the artificial pancreas system could safely and effectively control blood glucose in early and late pregnancy in a closely supervised hospital setting, and in non-pregnant adults and children.
The team have now been able to test the impact of the system in real-life NHS settings. The women taking part in the study wore the artificial pancreas while living day-to-day, and 14 went on to use the system during labour and delivery (including vaginal, elective and emergency caesarean section), with all 16 women giving birth to healthy babies.
The women, aged from 16 to 44 years, joined the study when they were around 12-14 weeks pregnant, using either the artificial pancreas or an insulin pump alone for 28 nights. After this, they switched over to use the alternative system for a further 28 nights. Interestingly, 14 out of the 16 women chose to continue using the artificial pancreas for the remainder of their pregnancy and during childbirth.
The artificial pancreas was shown to be safe, it improved management of blood glucose levels. Women using the system spent more time (approximately 75 per cent or 18 hours per day) with their blood glucose levels within target range (3.5 to 7.8 mmol/L) overnight, compared to approximately 60 per cent (14 hours per day) in those using the insulin pump and sensor without an artificial pancreas. Previous research showed that women with Type 1 diabetes only spend 12 hours per day within the target range during pregnancy, so these findings are a really important step forwards. Using the artificial pancreas also halved the time spent with high blood glucose levels (over 10 mmol/L).
There was no difference between the two groups in terms of their total daily insulin dose or the number of hypoglycaemic events (dangerously low blood glucose levels).
Combatting concerns that the artificial pancreas would be difficult to use, several of the women had never used an insulin pump before taking part, relying entirely on multiple daily injections. The researchers found equally beneficial outcomes between those women using injections and those who had previously used a pump.
Following on from the success of this study, the team are now testing the artificial pancreas in a further 16 pregnant women with Type 1 diabetes, compared to insulin pump therapy. The difference is instead of using a tablet device as part of the artificial pancreas, they are now using a mobile phone. The researchers hope to be able to replicate these findings in a much larger clinical trial across the UK in the near future but it will be a few years before this is available in clinic.