Table 3.

CREATE trial schedule of assessments

^aIncludes diabetic, clinical and lifestyle review.

^bSeated blood pressure, recorded as the average of two measurements at least five minutes apart.

^cA urine pregnancy test for females of child bearing potential only (all postmenarchal and premenopausal women).

^dVersions of the Hypoglycaemia Fear Survey II include: Both child and parent version to be completed for participants 7-17 years inclusive, and the adult version to be completed for participants 18 years inclusive and older.

^eThe PSQI will only be completed by participants 13 years inclusive and older.

^fDTSQs versions include: Parent version to be completed for participants 7-12 years inclusive, teen version to be completed by participants 13-17 years inclusive (parents can also do this), and the adult version to be completed by participants 18 years inclusive and older.

^gThe EQ-5D-Y will be completed by participants 8-15 years inclusive. The EQ-5D-5L will be completed by participants 16 years (inclusive) and older. This questionnaire will not be completed by participants 7 years of age.

^hAll participants will be asked to complete a food diary at home using the Research Food Diary app on four non-consecutive days (three weekdays and one weekend day) over one week during the run-in period and during the last week of the RCT phase.

ⁱPump settings will be reviewed remotely by investigative staff and adjustments made as clinically indicated.

^jUp to 15 adults and up to 15 children/caregivers, and all Māori participants who have completed the RCT on AID will be invited to attend an interview (face-to-face or via video teleconferencing) with a member of the research team during the first six weeks of the continuation phase (days 168 - 210).

^kAll Māori participants who have transferred from the SAPT group to the AID group for the continuation phase will be invited to attend an interview (face-to-face or via video teleconferencing) with a member of the research team within six weeks of completing the continuation phase.

^lOne remote focus group will be held with participating HCPs via video conferencing and will be conducted within one month of all sites having five participants on AID complete the first three months of the RCT phase. Interviews with a selection of HCPs may also be conducted at each site as all the all participants randomised to AID at their site complete the RCT phase (to occur within one month of the site‘s last subject completing AID during the RCT phase).

^mAll participants who discontinue the trial will be invited to take part in a face-to-face interview (either at the research centre or via a video conference) with a research staff member within four weeks of discontinuing the study.