Table 3.
Difference in Additional Secondary Endpoints Between the Hybrid Closed-Loop Intervention and Continuous Subcutaneous Insulin Infusion Control
| HCL (age 39.9 ± 19.8 years) |
CSII (age 35.7 ± 18.4 years) |
Difference (HCL − CSII) | P | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | Baseline | Study end | Change | n | Baseline | Study end | Change | |||
| Group 1 + Group 2 | ||||||||||
| TBR <70 mg/dL, %a (nighttime) | 151 | 8.7 ± 10.3 | 2.3 ± 3.3 | NA | 151 | 8.0 ± 9.7 | 7.7 ± 9.4 | NA | −5.4 (−7.1 to −3.7) | <0.0001b |
| TBR <70 mg/dL, %a | 151 | 6.2 ± 5.5 | 2.4 ± 2.1 | NA | 151 | 6.5 ± 5.8 | 6.0 ± 5.4 | NA | −3.6 (−4.6 to −2.6) | <0.0001b |
| TIR, %a (nighttime) | 151 | 53.6 ± 20.7 | 73.8 ± 14.3 | NA | 151 | 51.9 ± 17.5 | 55.0 ± 20.8 | NA | 18.8 (14.5, 23.1) | <0.0001b |
| TIR, %a | 151 | 52.5 ± 16.1 | 67.4 ± 10.8 | NA | 151 | 51.8 ± 13.1 | 55.4 ± 15.0 | NA | 12.0 (8.8, 15.1) | <0.0001b |
| A1C, %a | 151 | 8.3 ± 1.4 | 7.3 ± 0.8 | −1.0 ± 1.2 | 151 | 8.1 ± 1.1 | 7.7 ± 1.0 | −0.4 ± 0.9 | −0.6 (−0.8 to −0.3) | <0.0001c |
Additional secondary glycemic endpoints that included the %TBR <70 mg/dL, %TIR, and change in A1C (Groups 1 + 2 combined) are shown. All analyses for %TBR <70 mg/dL and %TIR compared the end-of-study difference in %TBR <70 mg/dL and %TIR between the HCL intervention and CSII control (one-way ANOVA) and the analysis for A1C compared the change in A1C difference between the HCL intervention and CSII control (i.e., difference [HCL − CSII]).
Data are shown as mean ± SD or mean (95% CI) to one decimal place.
The n (number of randomized participants) for study end and change may differ due to study period withdrawals.
Time in HCL was 79.7% ± 16.2%.
Nighttime was 12:00 AM–5:59 AM.
Superiority test.
Comparison of end-of-study %TBR <70 mg/dL or %TIR between HCL intervention and CSII control.
Comparison of change in A1C between HCL intervention and CSII control.
TIR, time in target range.