Table 2.
Schedule of study visits
| Visit/contact | Description | |
|---|---|---|
| Visit 1 | Recruitment visit: consent, HbA1c, baseline bloods, urine pregnancy test, baseline questionnaires and interviews | |
| Training | Visit 2 | Insulin pump training Initiation study pump, Competency assessment |
| Visit 3 | CGM training Initiation of study CGM, Competency assessment | |
| Optimisation (4 weeks) | Visit 4 | Review pump and CGM data and optimisation of treatment. Further device training as required |
| Visit 5 | Review pump and CGM data and optimisation of treatment | |
| Visit 6 | Review pump and CGM data and optimisation of treatment | |
| Visit 7 | Review pump and CGM data and optimisation of treatment | |
| CL Intervention (3 months) | Visit 8 | CL initiation at research facility, urine pregnancy test, CL training, competency assessment, HbA1c |
| Visit 9* | Review use of study devices; further optimisation as required | |
| Visit 10* | Review pump and CGM data; further optimisation as required | |
| Visit 11* | End of first month; review pump and CGM data; further optimisation as required | |
| Visit 12* | End of second month; review pump and CGM data; further optimisation as required | |
| Visit 13 | End of closed-loop treatment arm (3 months) HbA1c. Complete questionnaires and optional interviews. Collect algorithm device (optional return of CGM and study pump) | |
| – | Washout period | |
| Visit 14 | Optional—collection of CGM and study pump if handed back during visit 13 | |
| SAP Intervention (3 months) | Visit 15 | SAP initiation at research facility, urine pregnancy test, SAP training, competency assessment,—HbA1c |
| Visit 16* | Review use of study devices; further optimisation as required | |
| Visit 17* | Review pump and CGM data; further optimisation as required | |
| Visit 18* | End of first month; Review pump and CGM data; further optimisation as required | |
| Visit 19* | End of second month; Review pump and CGM data; further optimisation as required | |
| Visit 20 | End of SAP arm (3 months) HbA1c. Complete questionnaires and optional interviews. Collect all study devices |
*Could be done via phone/e-mail. The order of CL and SAP interventions will be random.
CGM, real-time continuous glucose monitoring; CL, closed loop; HbA1c, glycated haemoglobin; SAP, sensor augmented pump therapy.