University of Galway-based Prof Fidelma Dunne is internationally respected for her work on gestational diabetes, not least her recent metformin study.
Last year, Prof Fidelma Dunne and her team made a significant research breakthrough that could impact how women cope with gestational diabetes, a condition characterised by elevated blood sugar levels during pregnancy, which poses increased health risks for mothers and their babies. Finding treatments that are both non-invasive and effective is paramount.
Dunne, who is based at the University of Galway, managed a clinical trial that involved 535 pregnant women. Of those, 268 received metformin – a drug used to treat Type 2 diabetics – while 267 took a placebo. A small percentage (4.9pc) of women discontinued the medication due to side effects, but 98pc remained in the trial until delivery – with 88pc completing the 12-week post-delivery follow-up assessment.
Early intervention with metformin
Dunne’s team concluded that early intervention with metformin can be a game-changer for women at risk of diabetes during pregnancy. The trial’s results, she said, are a “significant step forward for women with gestational diabetes”.
She presented her findings last October at the 59th annual meeting of the European Association for the Study of Diabetes in Hamburg, Germany.
“Metformin has emerged as an effective alternative for managing gestational diabetes, offering new hope for expectant mothers and healthcare providers worldwide,” she said.
When she is not lecturing in Hamburg, Dunne works as a professor of medicine at University of Galway and as consultant endocrinologist at Saolta University Health Care Group. She is an adjunct professor at Denmark’s Steno Diabetes research centre and president of the Irish Endocrine Society. Up until 2021, she served on the board of the Irish Medical Council.
‘I find diabetes fascinating’
Speaking to SiliconRepublic.com, she explained that diabetes research has always fascinated her, and she first became involved in diabetes in pregnancy in 1995 as part of her clinical training. She became a consultant endocrinologist in 1996.
At the time, this was a relatively new area of practice but Dunne “was hooked very early”. Why did she decide to stick with it?
“I find diabetes fascinating and as medicine has advanced the treatment options have become amazing. Technology for measuring sugar and pumps for delivering insulin have also revolutionised management. In treating patients with these new medicines and technologies, you can witness enormous clinical change, which is rewarding.”
As with a lot of academics in the medical field, patient outcomes are a huge motivator for Dunne – all the more since her area is dealing with very vulnerable patients just about to enter the world. She finds it motivates her to see women who are themselves motivated to “achieve exceptional diabetes control” in order to change the outcome of their pregnancy.
“It is rewarding to see ongoing improvements with small treatment changes implemented frequently,” she said. “When looking after a pregnant woman with diabetes you are affecting the health of both the mother-to-be and her baby for the pregnancy, but your clinical care also impacts on the future health. What you do clinically in pregnancy, leads to foetal programming that will determine the baby’s future health in terms of obesity, diabetes and heart disease. Likewise for the mother, the care you give in pregnancy, especially by controlling excess weight gain and keeping sugar tightly controlled, can affect the woman’s long term health.”
Metformin versus insulin and unanswered questions
It is all quite high-stakes stuff. But the results of the metformin trial show there are ways to manage gestational diabetes.
The women who were given metformin were 25pc less likely to need insulin, and when insulin was needed it started later in the pregnancy. Women who took metformin gained less weight during the trial and their fasting and post-meal sugar values were significantly at weeks 32 and 38.
The study found no differences in adverse neonatal outcomes, including the need for intensive care treatment for new-borns, respiratory support, jaundice, congenital anomalies, birth injuries or low sugar levels. There were also no changes in rates of labour induction, caesarean delivery, maternal haemorrhage, infection or blood pressure issues during or after birth.
Additionally there were no variations in rates of labour induction, caesarean delivery, maternal haemorrhage, infection or blood pressure issues during or after birth. There were slightly more babies who were small at birth but this did not reach statistical significance. That finding could prove key to metformin overtaking insulin as a treatment for gestational diabetes. As Dunne has said previously, her trial was not the first to compare insulin and metformin, but it did answer questions medics had following other trials about preterm birth and infant size.
“Traditionally, gestational diabetes has been managed initially through dietary advice and exercise, with insulin introduced if sugar levels remain sub-optimal,” said Dunne. But insulin is not the most safe treatment. “While effective in reducing poor pregnancy outcomes, insulin use is associated with challenges, including low sugars in both the mother and infant which may require neonatal intensive care, excess weight gain for mothers and higher caesarean birth rates.”
And babies born to mothers with gestational diabetes face their own set of risks, such as excessive weight at birth, birth injuries, respiratory difficulties and low sugar levels after delivery. As Dunne knows from her years of collecting data looking at pregnancy outcomes for women with diabetes, low and middle-income countries “bear a significant burden of gestational diabetes cases”.
The care that goes into clinical trials
“Designing and running clinical trials takes with it an enormous responsibility; as a principal investigator as you are responsible for everything to do with the trial. Planning, therefore, is slow and detailed, but attention to detail with these processes is essential and it pays off when executing the trial.”
Among the things Dunne had to factor in was ensuring the sample enrolled in the trial was truly representative of the population and that the location for the trial had sufficient number of experts trained in things like pharmacovigilance, ethics, biostatistics, reporting and financing. Even the text in documents needed to be given “particular attention” because they would be translated to many languages. Dunne recommended a translation service.
Plenty of room in the lab for young researchers
In general terms, if she was to give advice to people hoping to go into her field what would it be? She said there is “lots of room for other researchers” as diabetes in pregnancy still has a lot of “unanswered questions” attached to it.
Plus, “maternal health is an important health focus for any population. Improving the health of women will improve the health of their children and families. This has important health social and economic gains for a nation.
“Young researchers should get involved in an established research group, as this way you get started on your journey quicker. Get involved in a number of simultaneous projects and try to contribute to them all as a co-investigator.
“They will come to completion at different times and not all of them will be successful, so employing this strategy means you will likely have some success.
“Also, educate yourself in the fundamentals of clinical trial processes through an MSc,” said Dunne, who holds an MSc in clinical trials from the University of Galway and an MSc in medical education from Scotland’s Dundee University.
Her last piece of advice? “Start grant writing early.” That is sure to resonate with a lot of academics.
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