This study is trying to find a way to reduce the number of times blood sugar levels go too low in babies being treated with insulin.
Premature babies can’t control their blood sugar levels well and often have high blood sugar levels in the first few weeks after birth. High blood sugar levels can lead to problems with growth and development, so babies are often treated with insulin to lower the blood sugar levels to a more normal range. However, sometimes insulin treatment lowers the blood sugar levels too much, and very low blood sugar levels may also affect a baby’s development.
The HINT2 study (Hyperglycaemia and Insulin in Neonates Trial) is trying to find a way to reduce the number of times blood sugar levels go too low in babies being treated with insulin. We want to find out if using a computer program to tell us which dose of insulin to use reduces the risk of low blood sugars compared with how we usually give insulin.
Why is HINT2 important?
A team at the University of Canterbury has developed a computer program, which uses information such as a baby’s weight and how much sugar they are receiving, to work out how much insulin a baby needs and when the next blood sugar test should be done.
The computer program is already used in adults being treated with insulin because it is safe and effective. In one small study in preterm babies, the computer program also treated high blood sugar levels well and reduced the number of low blood sugar levels.
We now need to study this computer program in a larger group of babies to confirm whether it lessens the risk of low blood sugar levels and improves outcomes in preterm babies.
If this study shows that the computer program does work well and reduces the risk of low blood sugar levels in babies on insulin, then it will be used in the future to treat high blood sugar levels in preterm babies, thus benefiting other babies born very preterm who have this common problem.
This study also will help us understand more about how babies grow when they have high blood sugar levels and are treated with insulin.
What is HINT2 trying to find out?
We are trying to determine whether Computer Determined Dosage (CDD) reduces the incidence of insulin-induced hypoglycaemia in hyperglycaemic preterm babies treated with insulin, independently of frequency of blood glucose sampling.
Who can take part?
Babies born at less than 30 weeks or who weigh less than 1500g and develop hyperglycaemia can take part in the study.
What does participation in HINT2 involve?
Computer Program: If your baby develops high blood sugar levels, we will start treatment with insulin as usual. All babies on insulin need blood samples every few hours to check their blood sugar levels. All babies enrolled in the study will have the insulin dose prescribed by a doctor.
For some babies the computer program will be used to advise the doctors. For other babies the doctors will decide which dose of insulin to use. For some babies the computer program will advise when the blood sugar should be checked next, and for other babies the doctor will decide when to check the next blood sugar.
Your baby will be randomly placed in ONE of these three groups:
Group 1 – baby receives insulin dose advised by the computer program and the computer program suggests when the blood sugar is to be checked next.
Group 2 – baby receives insulin dose chosen by the doctor and the doctor selects from the computer tablet when the blood sugar is to be checked next.
Group 3 – baby receives insulin dose chosen by the doctor and the doctor decides when the blood sugar is to be checked next.
Measurements: All small babies have their weight, length and head circumference measured at least once a week to make sure they are growing well. The measurements will be done in the baby’s incubator or cot at a time when the baby is already awake, and do not cause the baby any discomfort.
Assessment at 2 years of age: Families will be invited to attend a follow-up assessment when their baby reaches 2 years of age. This assessment will involve growth measurements, health focussed questionnaires, and a developmental assessment. In most cases, these assessment are part of the routine follow-up of children born preterm.
What are the risks and benefits?
Your baby may benefit from participating in the study if we find that using the computer program reduces the risk of developing low blood sugar levels while on insulin treatment.
The computer program we are using to help treat high blood sugar levels may require a few more blood glucose levels to be taken than might usually be ordered by the doctor. We do not know whether this will itself lower the risk of low blood sugar levels. Many preterm babies who are treated with insulin already have special umbilical lines in place so doctors can check their blood sugar levels without disturbing them. In babies without these special lines, we can take a tiny sample of blood from the heel.
How can I find out more?
Please feel free to contact the study team on: 09 379 7440 ext. 25367 or email the trial coordinator at firstname.lastname@example.org