Table 3

Schedule of study visits/phone contacts when the participant is randomised to sensor-augmented pump

Visit/contactDescriptionStart relative to previous/next visit/activityDuration, hours
Visit 1Recruitment visit: consent
HbA1c, screening bloods and questionnaires, urine pregnancy test
Training and run-in
(4 weeks)
Visit 2Insulin pump training and the initiation 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
(3 months)
Visit 5SAP initiation at clinic/home: urine pregnancy test, SAP 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 SAP treatment arm (3 months): HbA1c, complete questionnairesAfter 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 the USA only.

  • CGM, continuous glucose monitoring; SAP, sensor-augmented pump; HbA1c, glycated haemoglobin.