Schedule of study visits when closed-loop intervention precedes sensor-augmented pump therapy
| Visit/contact | Description | Start relative to previous/next Visit/activity | Duration | Comment | |
| Consent and training | Visit 1 | Recruitment visit: Consent/assent, HbA1c questionnaires | – | 1–2 hours | |
| Visit 2 | CGM start: CGM training, initiation of CGM, competency assessment | Within 2 weeks of Visit 1 (may coincide with Visit 1) | 2–3 hours | May be repeated if competency not achieved | |
| Visit 3 | Pump start: insulin pump training, study pump initiation, competency assessment | Within 1 week of Visit 2 (may coincide with Visit 2) | 2–4 hours | May be repeated if competency not achieved | |
| Run-in 2–4 weeks | Contact 1 | Review pump settings and CGM data; adjustment of treatment | After 1 week of Visit 3 (±3 days) | 30 min | |
| Visit 4* | End of run-in, adjustment of treatment, treatment adherence assessment | After 2–4 weeks of Visit 3 (minimum of 2 weeks) | 1 hour | Run-in and Visit four may be repeated if non-compliant | |
| Randomisation | Immediately after Visit 4 | If compliant with pump & CGM use | |||
| CL Intervention 16 weeks | Visit 5 | CL initiation: training (CL), competency assessment | Within 1 week of Visit 4 | 1–2 hours | |
| Contact 2 | Follow-up after CL start | Within 24 –48 hours after Visit 5 | 30 min | ||
| Contact 3 | Follow-up, review use of study devices | After 1 week of Visit 5 (±3 days) | 30 min | ||
| Contact 4 | Follow-up, review use of study devices | After 4 weeks of Visit 5 (±2 weeks) | 30 min | ||
| Contact 5 | Follow-up, review use of study devices | After 8 weeks of Visit 5 (±2 weeks) | 30 min | ||
| Contact 6 | Follow-up, review use of study devices | After 12 weeks of Visit 5 (±2 weeks) | 30 min | ||
| Visit 6 | End of first study arm: device download, HbA1c, questionnaires, interview | After 16 weeks of Visit 5 (±2 weeks) | <1 hour | ||
| Washout period (1–4 weeks) | |||||
| Sensor-augmented pump therapy 16 weeks | Visit 7* | Sensor-augmented pump therapy initiation: refresher training | After 1–4 weeks of Visit 6 (minimum of 1 week) | 1–2 hours | |
| Contact 7 | Follow-up after Sensor-augmented pump therapy start | within 24 to 48 hours after Visit 7 | 30 min | ||
| Contact 8 | Follow-up, review use of study devices | After 1 week of Visit 7 (±3 days) | 30 min | ||
| Contact 9 | Follow-up, review use of study devices | After 4 weeks of Visit 7 (±2 weeks) | 30 min | ||
| Contact 10 | Follow-up, review use of study devices | After 8 weeks of Visit 7 (±2 weeks) | 30 min | ||
| Contact 11 | Follow-up, review use of study devices | After 12 weeks of Visit 7 (±2 weeks) | 30 min | ||
| Visit 8 (caregiver only) (UK and Luxembourg only) | Sleep assessment | After 12 weeks of Visit 7 (±2 weeks) (Visit 8 may coincide with Contact 11) | 30 min | ||
| Visit 9 | End of study, return and download of devices, HbA1c, questionnaires, interview, resume standard pump therapy | After 16 weeks of Visit 7 (±2 weeks) | <1 hour | ||
*Could be done via phone/email.
CGM, continuous glucose monitoring device; CL, closed-loop system; HbA1c, glycated haemoglobin.