Table 2.
Primary and Key Secondary Efficacy Outcomes
| Baseline N=113 | 670G Arm N=112 | AHCL Arm N=112 | ||
|---|---|---|---|---|
|
| ||||
| Hours of Data | ||||
| Mean ± SD | 319 ± 29 | 1604 ± 339 | 1652 ± 251 | |
| Percentage of Time above 180 mg/dL (10·0 mmol/L) Daytime (6:00 AM – 11:59 PM) | ||||
| Mean ± SD | 42% ± 13% | 37% ± 9% | 34% ± 9% | |
| Mean Adjusted Difference [95% CI] [P-Value] a | −3% [−4%, −2%] [<0·001] | |||
| Percentage of Time below 54 mg/dL (3·0 mmol/L)b (Over the Full 24 Hours of the Day) | ||||
| Mean ± SD | 0·46% ± 0·42% | 0·50% ± 0·35% | 0·46% ± 0·33% | |
| Mean Adjusted Difference [95% CI] [P-Value] a | −0·06% [−0·11%, −0·02%] [<0·001]c | |||
|
| ||||
| Keyt Secondary Outcomes | ||||
| Continuous Glucose Monitoring Outcomes (Over the Full 24 Hours of the Day) Mean ± SD | P-Value d | |||
| Mean Glucose mg/dL (mmol/L) | 173 ± 19 (9·6 ± 1·1) | 166 ± 13 (9·2 ± 0·7) | 159 ± 13 (8·8 ± 0·7) | <0·001 |
| Time in the Target Range (70–180 mg/dL, 3·9–10·0 mmol/L) | 57% ± 12% | 63% ± 8% | 67% ± 8% | <0·001 |
| Time in the Tight Target Range (70–140 mg/dL, 3·9–7·8 mmol/L) | 34% ± 11% | 40% ± 7% | 44% ± 7% | <0·001 |
| Time >180 mg/dL(10·0 mmol/L) | 41% ± 13% | 34% ± 8% | 31% ± 8% | <0·001 |
| Time >250 mg/dL(13·9 mmol/L) | 13% ± 8% | 10% ± 6% | 9% ± 5% | <0·001 |
| Time <70 mg/dL (3·9 mmol/L) | 2·3% ± 1·8% | 2·1% ± 1·4% | 2·1% ± 1·2% | 0·42 |
| Coefficient of Variation | 36·1% ± 4·2% | 36·5% ± 3·9% | 37·2% ± 3·3% | 0·001 |
| HbA1c Mean±SD % d (mmol/mol) | 7·9 ± 0·7 (63±8) | 7·6±0·6 (59±7) | 7·4±0·8 (57±9) | 0·03 |
Based on a repeated measures least squares regression model comparing the two treatment arms adjusting for period, pre-study MiniMed 670G use, and HbA1c at randomization as fixed effects. The model includes 3 time points: (1) baseline, (2) period 1 outcome, and (3) period 2 outcome. Carryover effect p-value was 0·93 for daytime time above 180 mg/dL (10·0 mmol/L) and 0·19 for time below 54 mg/dL (3·0 mmol/L).
Time < 54 mg/dL (3·0 mmol/L) was winsorized at the 10th and 90th percentiles to account for skewness.
P-value for non-inferiority (Non-inferiority limit = 2%).
Values for 670G and AHCL arms represent the end of period 1 only. Baseline mean and standard deviation were the same for each treatment arm. P-value calculated using a repeated measures least squares regression model comparing the two treatment arms adjusting for period and pre-study MiniMed 670G use as fixed effects. The model includes 2 time points: (1) baseline and (2) period 1 outcome.