Ethics Information

Ethical Oversight

The MoTHer study has been reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2023).

The ethics committee ensures the study is conducted responsibly, that the rights and welfare of participants are protected, and that the research meets the highest ethical standards.

Your Rights as a Participant

• Participation in this study is entirely voluntary. You can say no.
• You may withdraw at any time without giving a reason and without any impact on the clinical care you receive.
• You have the right to ask questions about the study at any time.
• Your personal information is protected under the Privacy Act 1988 (Cth) and will be handled in accordance with CSIRO's privacy obligations.
• No individual participant will be identified in any publication or presentation. All published data will be de-identified.
• Your personal details, including your name, will only be published with your explicit consent.

What the Study Involves

The MoTHer study examines the real-world use of a smartphone app and internet-based portal to monitor blood glucose levels and other health measures during treatment for diabetes in pregnancy.

As a participant you may be asked to:

• Record blood glucose levels using a Bluetooth-enabled meter that uploads to the MoTHer app
• Record other health measures such as symptoms and daily health goals
• Complete short surveys about your experience using the app
• Optionally participate in an interview or focus group to provide feedback

Risks and Benefits

Risks

There are no identified risks to taking part in this study. You will be advised to undertake the same health measurements that all women diagnosed with diabetes in pregnancy are routinely advised to do.

Benefits

• Your blood glucose results are automatically transmitted from the meter to the app via Bluetooth — no manual recording required
• You do not need to carry or bring a paper diary to appointments
• Your health care team can view your measurements in real time through the secure clinical portal

How Your Information Is Used

Information collected via the MoTHer app is kept in your hospital medical record as usual practice. Your health care team can view this information for your clinical care.

The CSIRO research team collects de-identified data to analyse the relationship between blood glucose readings and other health measures. All data is de-identified, stored on secure servers in Australia, and retained for 5 years before deletion.

Results will be published in peer-reviewed scientific journals and presented at scientific meetings. No individual participant will be identified.

Study Results

At the completion of the project, results will be available at: research.csiro.au/mother

Concerns or Complaints

If you have any concerns or complaints about the ethical conduct of this research, please contact the relevant Human Research Ethics Committee at your participating site, or reach out to the MoTHer project team.

See the Contact page for details.