Monitoring glucose levels in Australian children with early stage type 1 diabetes (T1D)

Consenting visit During this appointment, the parent/ guardian or mature minor will have a one-on-one telehealth appointment with a study team member who has expertise in CGM. Study procedures will be explained to ensure informed consent is received. Consent will be obtained via an online link. Demographics will be collected, and the parent/ guardian or mature minor will be emailed a video link that demonstrates sensors insertion, pairing and removal of the sensor (two 2-minute videos). CGM session A Researcher will liaise via phone or email to arrange the best time to commence a session. NOTE: For participants having glycaemic tests (e.g.HbA1c, random glucose or OGTT) as part of their clinical care, they can choose to wear CGM to coincide with when these measures are being conducted to enable these measures to be correlated with their CGM-derived metrics. The CGM system that will be utilised in this study will be the Dexcom G7, The Dexcom G7 sensors are factory-calibrated and do not require wearers to undergo finger prick blood glucose testing for calibration, enabling accurate sensor glucose readings to be conducted with minimal burden to participants. Equipment will be posted to an address chosen by the participant in a tracked postage satchel. The majority of participants will have a 1st degree relative with type 1 diabetes and hence have some experience with CGM insertion. For families who are not confident in sensor insertion phone support will be offered at a time suitable to both. Following 10-days of sensor wear, parent/ guardian or the mature minor will be advised to remove the first sensor and insert a second sensor to continue the CGM wear period. If the sensor falls off prior to 10 days, the parent/guardian or mature minor can reinsert a second sensor immediately. With every sensor that is removed the parent/guardian or mature minor will be asked to inspect the skin to ensure its integrity. This information will be recorded on paper or electronically as per the preference of the parent/guardian or mature minor. If after wearing the second sensor the participant has worn it for <14 days they will have a third sensor that can be inserted. A maximum of 3 sensors will be provided for each session to obtain a minimum of 14 days data. Whilst wearing the CGM, participants are encouraged continue their usual activities and eating habits. Researchers will liaise with the parent/ guardian or mature minor via phone and email during the study period and be available by a dedicated study phone number for troubleshooting or questions during usual working hours. At completion of the session the parent/ guardian or mature minor will be provided with a paid postage satchel to return all the equipment to the co-ordinating study site. This study protocol includes 6-monthly CGM for participants with no evidence of dysglycaemia (Stage 1) and 3-monthly CGM for participants with evidence of dysglycaemia from either traditional measures of glycaemia or CGM data. CGM data upload Following a session when the equipment is received back at co-ordinating study site the CGM data will be uploaded to a secure-access study specific CLARITY® clinic database that is cloud-based. The receiver will store data for 90 days ensuring plenty of time for the parent/ guardian or mature minor to return the equipment. The information uploaded into CLARITY® is TLS encrypted using TLS 1.1 or higher and will not contain any personal information with participants labelled by a unique study identifier. The researcher will notify the principal study investigator and clinical investigator/referring clinician that the participant has completed a CGM session and that CGM data have been uploaded to the study-specific CLARITY® clinic database. A PDF will be emailed to the referring clinician of the CLARITY® generated reports (Daily CGM traces, summary Ambulatory Glucose Profile (AGP) as part of this notification. These reports will provide details on the participants’ glucose values during the CGM wear period and enable the referring clinician to provide appropriate feedback to the participant and their family. Feedback from the session will be given to the parent/guardian or mature minor by the clinical investigator/referring clinician. This will include being provided with a paper/electronic copy of the AGP and recommendations on clinical follow-up. Survey All parents/guardians will be asked to complete a survey each year to gather information on parents’ experiences related to the application and use of the CGM, and any worry or anxiety caused by using the device or the information they receive. Additionally, an age-appropriate survey will also be offered to all children aged 8 years of age and above to answer questions related to their overall experiences. Survey questions will include those requiring answers using a Likert scale, short answers and multiple-choice answers. Participants will reach study completion when they are diagnosed with clinical type 1 diabetes and commence treatment with insulin (Stage 3), turn 18 years old, or the study ends, currently scheduled for end 2030.