Table 2

Schedule of study visits/phone contacts when the participant is randomised to day-and-night closed -loop combined with pump suspend feature (intervention group)

Visit/contactDescriptionStart relative to previous/next visit/activityDuration, hours
Visit 1Recruitment visit: consent,
HbA1c, screening bloods and questionnaires, urine pregnancy test
Training and
(4 weeks)
Visit 2Insulin pump training and the initiation of study pump, competency assessmentWithin 1–3 weeks of visit 13–4
Visit 3CGM training, initiation of CGM, weekly contact via phone/email, competency assessmentWithin 3–7 days of visit 22–3
Visit 4*Review pump and CGM data, optimisation of treatment, compliance assessment, randomisationAfter 4 weeks of visit 3<1
ContactQualitative interview (with a subset of participants/family members)After randomisation but before visit 5<1
(3 months)
Visit 5CL initiation at clinic/home: urine pregnancy test, CL and suspend feature training, competency assessment, HbA1cWithin 1 week of visit 42–6
Visit 6*Review use of study devicesAfter 24–48 hours of visit 5<1
Visit 7†Review use of study devicesAfter 1 week of visit 5<1
Visit 8*Review pump and CGM dataAfter 1 week of Visit 7<1
Visit 9*End of first month: review pump and CGM dataAfter 2 weeks of visit 8<1
Visit 10*End of second month: review pump and CGM dataAfter 4 weeks of visit 9<1
Visit 11End of closed-loop treatment arm (3 months): HbA1c, complete questionnaires and follow-up qualitative interviewsAfter 4 weeks of visit 101–3
  • *Could be done via phone/e-mail in the UK. Follow-up by phone is mandatory in the USA only.

  • †Could be done via phone/e-mail in the UK. In-person visit mandatory in USA only.

  • CGM, continuous glucose monitoring; CL, closed loop; HbA1c, glycated haemoglobin; LGS, low glucose suspend.