Table 1

Efficacy and safety outcome measures

Control arm (N = 45)Intervention arm (N = 45)P value
Number of nights970942
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
   ≤501910<0.001
   ≤60*3321<0.001
   ≤704532<0.001
  Percentage of nights with ≥2 consecutive values ≤60 mg/dL3119<0.001
  Percentage of nights with ≥5 consecutive values ≤60 mg/dL2514<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
   >18057590.17
   >25020200.93
   >300560.37
   >40000
  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
  ≤604<1<0.001
  ≤7092<0.001
  71–18070700.87
  >1802127<0.001
  >250660.71
 Percentage of mornings with blood ketone >1.0 mmol/L§0.30.10.62
 Percentage of mornings with urine ketones ≥15 mg/dL230.10
  • *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.