Research Article

Characterizing Glycemic Control and Sleep in Adults with Long-Standing Type 1 Diabetes and Hypoglycemia Unawareness Initiating Hybrid Closed Loop Insulin Delivery

Table 1

BMI and glycemic characteristics at baseline and at 3 months, 6 months, and 9 months after initiating hybrid closed loop insulin delivery and the change values from baseline to 9 months in BMI and glycemic characteristics.

VariableBaseline
Mean (SD)
3 months
Mean (SD)
6 months
Mean (SD)
9 months
Mean (SD)
-testEffect sizea
Baseline to 9 months

BMI24.18 (1.12)24.54 (1.63)23.73 (1.41)24.51 (1.36)-0.780.470.26
HbA1c (%)7.25 (1.33)7.48 (0.56)7.60 (1.03)7.48 (1.06)-0.640.550.19
Mean sensor glucose (mg/dL)147.83 (24.32)156.33 (23.75)154.50 (28.56)153.67 (32.50)-0.610.570.20

Percentage of time sensor glucose was in range
 70-180 mg/dL66.60 (12.80)68.00 (15.02)68.40 (21.34)70.00 (23.48)-0.430.690.28

Percentage of time sensor glucose was below and above range (total)
 <54 mg/dL1.50 (1.93)0.86 (0.87)0.37 (0.28)0.51 (0.68)1.210.280.68
 <60 mg/dL2.35 (2.83)1.38 (1.32)0.72 (0.33)0.88 (0.91)1.320.240.70
 <70 mg/dL4.86 (5.34)2.54 (2.00)2.01 (0.84)2.22 (1.42)1.360.230.67
 >180 mg/dL25.63 (15.20)27.57 (16.07)27.88 (20.05)26.41 (22.33)-0.130.900.04
 >250 mg/dL4.66 (4.25)7.29 (8.01)6.54 (9.72)7.58 (12.11)-0.610.570.32

Percentage of time sensor glucose was below and above range during the daytime as defined by accelerometry estimated sleep-wake period
 <54 mg/dL1.25 (1.25)1.15 (1.02)0.49 (0.51)0.67 (0.91)0.990.370.52
 <60 mg/dL1.99 (2.05)1.83 (1.59)0.91 (0.58)1.12 (1.22)1.140.310.52
 <70 mg/dL4.27 (4.22)3.37 (2.60)2.40 (1.20)2.70 (2.11)1.210.280.47
 >180 mg/dL26.50 (17.72)30.89 (15.15)32.29 (17.38)30.84 (22.26)-1.110.320.22
 >250 mg/dL4.70 (4.32)9.37 (9.55)8.04 (10.37)8.70 (13.52)-0.910.400.40
Percentage of time sensor glucose was below and above range during the nighttime as defined by accelerometry estimated sleep-wake period

 <54 mg/dL1.99 (3.93)0.30 (0.72)0.25 (0.25)0.21 (0.33)1.070.330.64
 <60 mg/dL3.02 (5.16)0.54 (0.98)0.47 (0.48)0.44 (0.51)1.170.300.70
 <70 mg/dL5.93 (8.09)1.00 (1.03)1.49 (1.14)1.36 (1.36)1.270.260.79
 >180 mg/dL24.26 (15.86)19.82 (21.98)20.45 (26.20)18.35 (24.21)0.590.580.29
 >250 mg/dL4.67 (7.24)6.56 (8.90)4.17 (8.81)5.05 (10.06)-0.070.950.04

Sensor glucose variability
 Standard deviation41.86 (20.13)44.86 (21.07)42.57 (20.28)42.00 (19.41)0.070.950.01
 Coefficient of variation (%)33.50 (6.37)33.27 (2.37)31.83 (1.72)31.33 (1.51)0.820.450.47

Insulin requirements
 Average total daily (U/d)a33.60 (8.47)34.20 (10.83)32.20 (9.58)34.20 (13.74)-0.190.860.01
 Average daily boluses (U/d)a17.60 (6.47)18.80 (9.88)18.20 (7.60)19.80 (12.28)-0.820.460.25
 Average daily basal (U/d)a16.00 (5.15)15.40 (3.51)14.00 (4.30)14.40 (4.04)1.040.360.48
Clarke score5.17 (1.17)n/a4.50 (1.05)n/a1.350.24b0.60b
HYPO score909.33 (615.85)n/a322.67 (494.35)n/a1.690.15b1.06b
Lability index351.17 (145.38)n/a280.82 (137.18)n/a1.240.27b0.50b

a. bBaseline to 6 months.