Question 1

Are there risks to me in taking part in this study?

Accepted Answer

All studies have some risk. This is rare and every care will be taken to avoid this. There are no known serious risks with the use of the CGM device. About 1 in 1000 people using CGM notice itchiness, pain, redness, burning, bruising, some difficulty with sleeping and attention. If you have any problem as result of this study, contact Dr Daria Di Filippo ASAP. She will help you in getting care.

Question 2

Is there any risk to my unborn baby?

Accepted Answer

Our study won't representa risk to your pregnancy, but will give us the chance to improve the future pregancies' journey.

Question 3

Is CGM painful during insertion/wearing/removal?

Accepted Answer

CGM is made by a small patch that stays on your skin with a small narrow tube inserted just below the skin. You may have mild pain and little discomfort when the tube first goes in. This is less painful than a blood test and lasts only a few seconds. CGM is not perceived when worn. Removing the CGM only takes a few minutes and is not painful.

Question 4

Does this replace the OGTT test? Will I receive also the normal antenatal care?

Accepted Answer

This do not replace the OGTT test. You will need to undergo the OGTT test during the CGM wearing period of 7 days (on the last day). During and after this study, any treatment and care during your pregnancy will be provided to you as normal by your Antenatal Care Team of reference.

Question 5

What happens if the device is damaged or accidentally removed between visits?

Accepted Answer

Please contact the leading investigator Dr Daria Di Filippo and she will arrange a replacement if needed.

Question 6

Do I need to advise my treating Doctor that I am taking part in the study?

Accepted Answer

You can inform your doctor if you wish to do so. We will provide you with the results of your OGTT test.

Question 7

Is there any monetary compensation for patients?

Accepted Answer

At completion of the study, you will receive a 30 AUD supermarket voucher to thank you for your participation.

Question 8

What is the benefit from the study?

Accepted Answer

If we show CGM is more reliable at diagnosing GDM, CGM could replace GTT. It could make women’s life easier. Future pregnant women wouldn’t have to do the GTT, wait two hours to check for GDM, or do finger pricks to check their sugar levels.

Question 9

What happens with the results?

Accepted Answer

We plan to write up the results in a medical journal. We also hope to use the results from this small study to get more money for a larger study. We will give you the results of the study, if you wish.