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. 2020 Feb 21;22(3):174–184. doi: 10.1089/dia.2019.0286

Table 2.

Glycemic Outcomes During the 96-h Hybrid Closed-Loop Period and 7-Day Standard Therapy Period

Parameter Adults (N = 11)
Adolescents (N = 10)
Children (N = 15)
HCL ST P HCL ST P HCL ST P
Overall
 Mean sensor glucose, mg/dL 150 ± 11 149 ± 26 0.8 144 ± 20 161 ± 25 0.08 156 ± 22 176 ± 28 0.02*
 Standard deviation, mg/dL 49 ± 9 55 ± 17 0.1 43 ± 11 61 ± 11 0.02* 54 ± 10 68 ± 14 0.02*
 Coefficient of variation, % 33 ± 4 37 ± 7 0.07 29 ± 4 38 ± 6 0.02* 35 ± 4 39 ± 3 0.04*
 Percentage time in glucose range, %
  <54 mg/dL 0.2 ± 0.3 1.2 ± 1.6 0.001* 0.4 ± 0.4 0.8 ± 0.8 0.4 0.3 ± 0.4 0.6 ± 0.6 0.2
0 [0–0.4] 0.6 [0.1–1.7] 0.2 [0.1–0.4] 0.4 [0.1–1.8] 0.2 [0–0.6] 0.5 [0.2–1.0]
  <60 mg/dL 0.4 ± 0.4 2.3 ± 2.6 0.002* 0.7 ± 0.8 1.6 ± 1.9 0.4 0.8 ± 0.8 1.1 ± 0.9 0.2
0.4 [0.1–0.6] 1.4 [0.6–3.0] 0.6 [0.3–1.1] 0.8 [0.5–3.2] 0.6 [0.2–1.7] 0.8 [0.4–1.6]
  <70 mg/dL 1.9 ± 1.3 5.1 ± 4.8 0.005* 2.5 ± 2.0 4.4 ± 4.0 0.3 2.2 ± 1.9 2.9 ± 2.4 0.3
1.7 [0.7–2.6] 3.2 [1.9–7.0] 2.4 [0.8–3.0] 2.8 [1.5–7.5] 1.9 [0.6–2.8] 2.2 [1.5–3.7]
  70–140 mg/dL 49.4 ± 9.2 46.6 ± 16.2 0.4 54.3 ± 15.6 39.9 ± 14.9 0.04* 47.1 ± 12.3 34.5 ± 13.5 0.01*
  70–180 mg/dL 73.7 ± 7.5 68.0 ± 15.6 0.08 79.0 ± 12.6 60.6 ± 13.4 0.01* 69.2 ± 13.5 54.9 ± 12.9 0.003*
  >180 mg/dL 24.5 ± 7.7 26.9 ± 16.7 0.5 18.5 ± 13.5 35.0 ± 16.2 0.03* 28.7 ± 14.1 42.2 ± 14.7 0.007*
24.4 [18.1–29.7] 29.8 [10.5–41.2] 12.3 [10.1–24.8] 31.3 [27.8–44.5] 26.1 [17.3–37.0] 45.4 [34.1–50.4]
  ≥250 mg/dL 4.5 ± 4.2 7.4 ± 9.6 0.1 3.5 ± 5.0 12.0 ± 6.5 0.02* 8.6 ± 8.8 17.5 ± 11.4 0.03*
3.4 [1.5–5.7] 4.7 [1.1–7.6] 0.7 [0.0–8.3] 12.5 [6.7–14.7] 6.3 [3.1–11.5] 16.0 [6.0–24.5]
  ≥300 mg/dL 1.1 ± 1.7 2.9 ± 5.8 0.4 0.7 ± 1.0 4.4 ± 3.7 0.02* 2.5 ± 3.1 8.3 ± 7.2 0.007*
0.3 [0.0–2.2] 0.0 [0.0–3.6] 0.0 [0.0–2.0] 3.8 [1.6–6.7] 1.5 [0.1–2.8] 6.1 [1.9–13.7]
Overnight (23:00–07:00)
 Mean sensor glucose, mg/dL 152 ± 32 153 ± 39 0.8 141 ± 27 153 ± 31 0.3 155 ± 29 177 ± 34 0.003*
 Standard deviation, mg/dL 41 ± 14 54 ± 18 0.01* 30 ± 13 54 ± 15 0.01* 46 ± 15 61 ± 19 0.03*
 Coefficient of variation, % 26 ± 6 36 ± 10 0.02* 20 ± 5 36 ± 10 0.01* 30 ± 6 34 ± 6 0.1
 Percentage time in glucose range, %
  <54 mg/dL 0.2 ± 0.5 1.2 ± 2.1 0.2 0.1 ± 0.2 0.7 ± 1.0 0.09 0.1 ± 0.4 0.8 ± 1.1 0.08
0 [0–0] 0 [0–1.0] 0 [0–0] 0.1 [0–1.4] 0 [0–0] 0.2 [0–1.3]
  <60 mg/dL 0.2 ± 0.6 2.5 ± 4.0 0.07 0.3 ± 0.5 2.2 ± 2.8 0.1 0.3 ± 0.7 1.2 ± 1.4 0.1
0 [0–0.3] 0.5 [0–2.8] 0 [0–0.5] 0.8 [0–4.0] 0 [0–0] 0.7 [0–2.5]
  <70 mg/dL 0.7 ± 1.1 5.4 ± 7.5 0.05 1.3 ± 1.6 6.5 ± 6.6 0.04* 1.0 ± 1.9 2.6 ± 2.5 0.08
0.3 [0–1.0] 1.9 [0.5–6.9] 0 [0–3.0] 3.6 [1.7–10.3] 0 [0–1.6] 1.9 [0.2–4.4]
  70–140 mg/dL 52.7 ± 28.4 47.3 ± 21.8 0.4 59.6 ± 21.7 41.3 ± 20.1 0.04* 52.5 ± 18.4 32.7 ± 16.7 0.0004*
  70–180 mg/dL 73.9 ± 21.0 65.5 ± 22.7 0.05 85.4 ± 17.9 62.1 ± 15.7 0.02* 73.8 ± 19.3 53.4 ± 18.8 0.0001*
  >180 mg/dL 25.3 ± 21.2 29.1 ± 23.9 0.6 13.3 ± 18.7 31.4 ± 20.5 0.07 25.2 ± 19.7 44.0 ± 20.8 0.0003*
24.3 [14.1–28.1] 23.3 [12.3–38.4] 4.6 [0.0–24.3] 26.4 [19.6–34.9] 19.5 [10.2–36.2] 46.5 [27.7–60.8]
  ≥250 mg/dL 6.1 ± 10.9 8.7 ± 14.1 0.3 3.3 ± 7.0 7.5 ± 7.2 0.3 8.6 ± 11.7 16.5 ± 15.0 0.04*
0.5 [0.0–5.5] 4.0 [0.0–11.3] 0.0 [0.0–5.3] 4.6 [1.6–13.9] 3.4 [0.0–17.4] 9.0 [3.8–28.9]
  ≥300 mg/dL 1.3 ± 2.8 4.1 ± 8.8 0.2 0.0 ± 0.0 2.9 ± 5.1 0.1 1.8 ± 3.4 7.2 ± 10.3 0.04*
0.0 [0.0–0.3] 0.0 [0.0–6.4] 0.0 [0.0–0.0] 0.0 [0.0–5.6] 0.0 [0.0–3.6] 2.1 [0.0–14.8]

Results are sensor glucose values, mean ± SD or median [IQR]; SI conversion factor to convert glucose to mmol/L, multiply by 0.0555.

*

Statistically significant with P < 0.05.

HCL, hybrid closed-loop; IQR, interquartile range.