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. Author manuscript; available in PMC: 2021 Feb 1.
Published in final edited form as: Lancet Digit Health. 2020 Jan 3;2(2):e64–e73. doi: 10.1016/S2589-7500(19)30218-3

Figure 1.

Figure 1.

Figure 1.

Study design

Panel 1: Overall Design

Panel 1: Study participants were randomized into one of two groups: Group A following the sequence of sessions SAP → E-N CLC → 24–7 CLC → E-N CLC, and Group B following the sequence of sessions EN CLC → 24–7 CLC → E-N CLC → SAP. Each treatment session continued for 8 weeks; treatment sessions were separated by 2-week washout periods during which HbA1c was measured and questionnaires were collected.

Panel 2: Sub-analyses (SAs) addressing the study objectives:

Panel 2: The overall design include two cross-over designs: SA1 comparing SAP vs. Evening-Night Closed-Loop Control and SAP during the day, and SA2 comparing Evening-Night Closed-Loop Control and SAP during the day vs 24–7 closed-loop control. A third sub-analysis, SA3, allowed the comparison of escalating vs. de-escalting treatments, SAP → E-N CLC → 24–7 CLC (Group A) vs. 24–7 CLC → E-N CLC → SAP (Group B).