. | Control arm (N = 45) . | Intervention arm (N = 45) . | P value . |
---|---|---|---|
Number of nights | 970 | 942 | |
Bedtime measures | |||
Bedtime sensor glucose, mg/dL [median (IQR)] | 144 (109–192) | 143 (110–189) | |
Bedtime blood glucose, mg/dL [median (IQR)] | 152 (114–197) | 144 (115–195) | |
Overnight measures using CGM sensor | |||
Number of measurements/night [median (IQR)] | 96 (84–110) | 96 (85–107) | |
Hypoglycemia outcomes | |||
Percentage of nights with ≥1 value, mg/dL | |||
≤50 | 19 | 10 | <0.001 |
≤60* | 33 | 21 | <0.001 |
≤70 | 45 | 32 | <0.001 |
Percentage of nights with ≥2 consecutive values ≤60 mg/dL | 31 | 19 | <0.001 |
Percentage of nights with ≥5 consecutive values ≤60 mg/dL | 25 | 14 | <0.001 |
Participant time <60 mg/dL per 8 h, min [median (IQR)]† | 23 (11–45) | 7 (3–12) | <0.001 |
Participant time <50 mg/dL per 8 h, min [median (IQR)]† | 10 (4–25) | 2 (0–4) | <0.001 |
Participant overnight AUC 60 mg/dL per 8 h [median (IQR)]† | 215 (88–482) | 40 (18–96) | <0.001 |
Participant LBGI [median (IQR)] | 2.28 (1.45–3.52) | 0.92 (0.69–1.63) | <0.001 |
Hyperglycemia outcomes | |||
Percentage of nights with ≥1 value, mg/dL | |||
>180 | 57 | 59 | 0.17 |
>250 | 20 | 20 | 0.93 |
>300 | 5 | 6 | 0.37 |
>400 | 0 | 0 | — |
Participant time >250 mg/dL per 8 h, min [median (IQR)]† | 12 (5–19) | 10 (4–19) | 0.78 |
Participant overnight AUC 250 mg/dL per 8 h [median (IQR)]† | 236 (83–772) | 219 (72–666) | 0.98 |
Participant HBGI [median (IQR)] | 4.17 (2.99–5.30) | 3.99 (2.50–5.73) | 0.95 |
Overall control outcomes | |||
Overnight mean glucose, mg/dL [median (IQR)] | 125 (98–163) | 132 (110–163) | <0.001 |
Percentage of glucose values 71–180 mg/dL [median (IQR)] | 75 (46–93) | 82 (54–99) | <0.001 |
Morning measures | |||
Morning blood glucose, mg/dL [median (IQR)]‡ | 129 (96–173) | 144 (114–186) | <0.001 |
Percentage of mornings with blood glucose, mg/dL | |||
≤60 | 4 | <1 | <0.001 |
≤70 | 9 | 2 | <0.001 |
71–180 | 70 | 70 | 0.87 |
>180 | 21 | 27 | <0.001 |
>250 | 6 | 6 | 0.71 |
Percentage of mornings with blood ketone >1.0 mmol/L§ | 0.3 | 0.1 | 0.62‖ |
Percentage of mornings with urine ketones ≥15 mg/dL¶ | 2 | 3 | 0.10 |
. | Control arm (N = 45) . | Intervention arm (N = 45) . | P value . |
---|---|---|---|
Number of nights | 970 | 942 | |
Bedtime measures | |||
Bedtime sensor glucose, mg/dL [median (IQR)] | 144 (109–192) | 143 (110–189) | |
Bedtime blood glucose, mg/dL [median (IQR)] | 152 (114–197) | 144 (115–195) | |
Overnight measures using CGM sensor | |||
Number of measurements/night [median (IQR)] | 96 (84–110) | 96 (85–107) | |
Hypoglycemia outcomes | |||
Percentage of nights with ≥1 value, mg/dL | |||
≤50 | 19 | 10 | <0.001 |
≤60* | 33 | 21 | <0.001 |
≤70 | 45 | 32 | <0.001 |
Percentage of nights with ≥2 consecutive values ≤60 mg/dL | 31 | 19 | <0.001 |
Percentage of nights with ≥5 consecutive values ≤60 mg/dL | 25 | 14 | <0.001 |
Participant time <60 mg/dL per 8 h, min [median (IQR)]† | 23 (11–45) | 7 (3–12) | <0.001 |
Participant time <50 mg/dL per 8 h, min [median (IQR)]† | 10 (4–25) | 2 (0–4) | <0.001 |
Participant overnight AUC 60 mg/dL per 8 h [median (IQR)]† | 215 (88–482) | 40 (18–96) | <0.001 |
Participant LBGI [median (IQR)] | 2.28 (1.45–3.52) | 0.92 (0.69–1.63) | <0.001 |
Hyperglycemia outcomes | |||
Percentage of nights with ≥1 value, mg/dL | |||
>180 | 57 | 59 | 0.17 |
>250 | 20 | 20 | 0.93 |
>300 | 5 | 6 | 0.37 |
>400 | 0 | 0 | — |
Participant time >250 mg/dL per 8 h, min [median (IQR)]† | 12 (5–19) | 10 (4–19) | 0.78 |
Participant overnight AUC 250 mg/dL per 8 h [median (IQR)]† | 236 (83–772) | 219 (72–666) | 0.98 |
Participant HBGI [median (IQR)] | 4.17 (2.99–5.30) | 3.99 (2.50–5.73) | 0.95 |
Overall control outcomes | |||
Overnight mean glucose, mg/dL [median (IQR)] | 125 (98–163) | 132 (110–163) | <0.001 |
Percentage of glucose values 71–180 mg/dL [median (IQR)] | 75 (46–93) | 82 (54–99) | <0.001 |
Morning measures | |||
Morning blood glucose, mg/dL [median (IQR)]‡ | 129 (96–173) | 144 (114–186) | <0.001 |
Percentage of mornings with blood glucose, mg/dL | |||
≤60 | 4 | <1 | <0.001 |
≤70 | 9 | 2 | <0.001 |
71–180 | 70 | 70 | 0.87 |
>180 | 21 | 27 | <0.001 |
>250 | 6 | 6 | 0.71 |
Percentage of mornings with blood ketone >1.0 mmol/L§ | 0.3 | 0.1 | 0.62‖ |
Percentage of mornings with urine ketones ≥15 mg/dL¶ | 2 | 3 | 0.10 |
*Boldface indicates prespecified primary outcome.
†For each patient, time below and above a threshold and AUC was divided by total time and multiplied by 8 h.
‡One morning blood glucose measurement in the control arm was missing.
§Nine blood ketone measurements in the control arm and 10 blood ketone measurements in the intervention arm were missing.
‖P value computed using permutation test because parametric analysis had convergence issue.
¶Twelve urine ketone measurements in the control arm and 12 urine ketone measurements in the intervention arm were missing.