Pregnant women are being invited by the University of Oxford and the NHS to take part in the world’s first clinical trial to prevent type 1 diabetes in babies and infants.
Researchers supported by the NIHR Oxford Biomedical Research Centre want to find out if giving small amounts of insulin to babies on the trial can prevent type 1 diabetes.
Pregnant women visiting the maternity clinics in Berkshire, Buckinghamshire, Milton Keynes and Oxfordshire are first being asked to take part in a study to identify the risk of their child developing type 1 diabetes.
Blood is routinely collected from newborns for screening tests for rare but serious conditions such as cystic fibrosis and sickle cell disease. Blood is taken from a small prick to the heel, which is then stored on a card.
The INvestigating Genetic Risk for type 1 Diabetes (INGR1D) study is asking women for consent to analyse a small part of the blood sample for genetic risk of type 1 diabetes.
About one per cent of children will have higher risk genes for type 1 diabetes and 10 per cent of those are expected to develop the condition. Researchers want to screen 30,000 babies across the Thames Valley over three years, to identify 300 at increased risk of developing this disease.
The parents of infants identified as having a higher risk of type 1 diabetes will then be offered an opportunity to take part in the Primary Oral Insulin Trial (POInT trial) to see if spoon-feeding high-risk children small doses of insulin powder each day can prevent them from developing the condition.
Participants on the trial will be given the powder or a placebo daily until they are three years old. They will have visits from the research team to monitor the child’s health.
It is hoped that spoon-feeding insulin powder can train the immune system to tolerate the body’s own insulin to prevent the onset of type 1 diabetes.
Type 1 diabetes is a lifelong condition where the pancreas does not produce insulin, which controls the amount of glucose in the blood. This causes blood glucose levels to become too high and can lead to long-term health problems such as blindness, cardiovascular disease and stroke. There is no treatment to prevent type 1 diabetes.
Selina Coleman from Bicester, Oxfordshire, whose daughter Zara was diagnosed with type 1 diabetes aged 13 months, welcomed the studies.
Mrs Coleman, 47, was advised to take Zara to A&E at the John Radcliffe Hospital by her GP in June 2007 because she was feeling unwell.
She said: “She was drinking excessively, she was very unhappy, and she was losing a lot of weight. A lot of the symptoms she was displaying were typical of diabetes so I rang the doctor who told us to go straight to A&E.”
The mother-of-two said: “She ended up in the high dependency unit at the John Radcliffe Hospital for three days and she was just a sea of pipes and leads and cables laying in a bed. It was a very challenging time.
“When you have a child you expect everything to run smoothly, so to be delivered the news that she was diagnosed with an incurable condition was a big blow and I was very upset at the time.
“You read about more and more children being diagnosed with type 1 diabetes, so it’s vital for this research to go ahead.”
Zara uses a portable pump to deliver insulin through a tube placed under the skin to control her diabetes.
Zara, now 12, said: “I can’t just eat what I want, I have to weigh up my food and work out how much insulin I need. I’ve got to always be focusing on it and have my attention on it. When I’m ill I usually feel a lot more ill than others and there are times where I’ve had to go into hospital because of it.
“Research into preventing diabetes sounds really amazing. For someone to have that chance to live without it and have that freedom would be great.”
The studies are part of the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD) in which the Oxford University group represents the UK. The group receives funding and support from the National Institute for Health Research (NIHR) (see notes to editors), the type 1 diabetes charity JDRF and the Wellcome Trust.
Dr Manu Vatish, Consultant in Obstetrics at Oxford University Hospitals and Chief Investigator for INGR1D, said: “Newborn screening has been very effective in detecting a number of rare conditions such as phenylketonuria, sickle cell disease and cystic fibrosis as well as inherited metabolic diseases. Knowing that there is an increased risk of type 1 diabetes can help us to identify babies that might ultimately benefit from the POInT trial.”
Dr Matthew Snape, Paediatric Consultant at OUH and Chief Investigator for POInT, said: “POInT is the first ever study aimed at primary prevention of type 1 diabetes, and in its approach represents an enormous breakthrough. Type 1 diabetes is a common, lifelong and challenging illness; preventing children and their families from having to live with diabetes and its threat of complications such as blindness, kidney or heart disease would be fantastic.”