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Table 3

Secondary CGM-measured glucose end points

Baseline (2 weeks)Postrandomization (final 11 weeks)
CLC (n = 63)SAP (n = 61)CLC (n = 64)SAP (n = 61)Risk-adjusted difference (90% CI)P value
Hours of sensor data, median (IQR) 304 (267, 323) 311 (294, 322) 1,656 (1,464, 1,781) 1,683 (1,565, 1,780) NA NA 
Hypoglycemia       
 CGM-measured % below 54 mg/dL (3.0 mmol/L), median (IQR) 1.1 (0.3, 2.1) 0.9 (0.2, 1.9) 0.5 (0.2, 0.8) 0.6 (0.2, 1.4)   
  Mean ± SD 1.7 ± 2.0 1.6 ± 2.4 0.6 ± 0.6 1.1 ± 1.2 −0.5 (−0.8, −0.2) 0.0009 
 CGM-measured % below 60 mg/dL (3.3 mmol/L), median (IQR) 2.0 (0.6, 3.8) 1.7 (0.6, 3.1) 0.9 (0.4, 1.4) 1.2 (0.5, 2.4)   
  Mean ± SD 2.8 ± 2.8 2.6 ± 3.3 1.1 ± 1.0 1.9 ± 1.9 −0.8 (−1.3, −0.4) 0.0003 
 CGM-measured LBGI, median (IQR) 1.0 (0.6, 1.7) 0.9 (0.4, 1.5) 0.6 (0.4, 0.9) 0.8 (0.5, 1.4)   
  Mean ± SD 1.3 ± 1.0 1.2 ± 1.2 0.7 ± 0.4 1.0 ± 0.8 −0.4 (−0.6, −0.2) <0.0001 
 CGM-measured hypoglycemic events,a median (IQR) 5.9 (3.5, 9.2) 5.5 (2.6, 8.3) 4.2 (2.5, 6.3) 4.8 (3.1, 8.2)   
  Mean ± SD 6.5 ± 4.3 5.7 ± 4.0 4.5 ± 2.7 5.9 ± 4.0 −1.9 (−2.9, −1.0) <0.0001 
Overall control       
 Glucose (mg/dL), mean ± SD 172 ± 30 177 ± 33 166 ± 19 170 ± 28 −1.3 (−7.8, 5.2) 0.82 
 CGM-measured % in range 70–180 mg/dL (3.9–10 mmol/L), mean ± SD 55 ± 16 53 ± 16 64 ± 11 57 ± 14 4.8 (1.4, 8.3) 0.0074 
 CGM-measured % in range 3.9–7.8 mmol/L (70–140 mg/dL), mean ± SD 34 ± 14 32 ± 14 39 ± 10 35 ± 12 3.0 (0, 6.0) 0.1047 
 CGM-measured CV (%), median (IQR) 39 (34, 44) 39 (35, 43) 37 (34, 41) 38 (35, 42)   
  Mean ± SD 39 ± 7 39 ± 7 37 ± 5 38 ± 5 −1.0 (−2.5, 0.5) 0.67 
Hyperglycemia       
 CGM-measured % above 250 mg/dL (13.9 mmol/L), median (IQR) 13.5 (5.0, 23.7) 13.9 (6.8, 26.6) 10.9 (5.3, 15.7) 11.3 (5.0, 17.3)   
  Mean ± SD 15.4 ± 11.8 17.5 ± 12.8 11.2 ± 7.4 13.7 ± 11.4 −1.2 (−4.0, 1.6) 0.82 
 CGM-measured % above 300 mg/dL (16.7 mmol/L), median (IQR) 4.4 (1.3, 12.3) 5.7 (1.5, 12.0) 3.4 (1.5, 6.1) 3.2 (1.1, 6.9)   
  Mean ± SD 6.8 ± 6.6 8.0 ± 8.2 4.4 ± 4.2 5.7 ± 7.1 −0.4 (−2.1, 1.3) 0.82 
 CGM-measured HBGI, median (IQR) 9.1 (5.6, 13.5) 9.6 (6.6, 14.0) 8.2 (5.9, 9.9) 8.6 (6.1, 10.6)   
  Mean ± SD 9.9 ± 5.0 10.8 ± 5.6 8.2 ± 3.3 9.3 ± 4.9 −0.6 (−1.7, 0.6) 0.82 
Baseline (2 weeks)Postrandomization (final 11 weeks)
CLC (n = 63)SAP (n = 61)CLC (n = 64)SAP (n = 61)Risk-adjusted difference (90% CI)P value
Hours of sensor data, median (IQR) 304 (267, 323) 311 (294, 322) 1,656 (1,464, 1,781) 1,683 (1,565, 1,780) NA NA 
Hypoglycemia       
 CGM-measured % below 54 mg/dL (3.0 mmol/L), median (IQR) 1.1 (0.3, 2.1) 0.9 (0.2, 1.9) 0.5 (0.2, 0.8) 0.6 (0.2, 1.4)   
  Mean ± SD 1.7 ± 2.0 1.6 ± 2.4 0.6 ± 0.6 1.1 ± 1.2 −0.5 (−0.8, −0.2) 0.0009 
 CGM-measured % below 60 mg/dL (3.3 mmol/L), median (IQR) 2.0 (0.6, 3.8) 1.7 (0.6, 3.1) 0.9 (0.4, 1.4) 1.2 (0.5, 2.4)   
  Mean ± SD 2.8 ± 2.8 2.6 ± 3.3 1.1 ± 1.0 1.9 ± 1.9 −0.8 (−1.3, −0.4) 0.0003 
 CGM-measured LBGI, median (IQR) 1.0 (0.6, 1.7) 0.9 (0.4, 1.5) 0.6 (0.4, 0.9) 0.8 (0.5, 1.4)   
  Mean ± SD 1.3 ± 1.0 1.2 ± 1.2 0.7 ± 0.4 1.0 ± 0.8 −0.4 (−0.6, −0.2) <0.0001 
 CGM-measured hypoglycemic events,a median (IQR) 5.9 (3.5, 9.2) 5.5 (2.6, 8.3) 4.2 (2.5, 6.3) 4.8 (3.1, 8.2)   
  Mean ± SD 6.5 ± 4.3 5.7 ± 4.0 4.5 ± 2.7 5.9 ± 4.0 −1.9 (−2.9, −1.0) <0.0001 
Overall control       
 Glucose (mg/dL), mean ± SD 172 ± 30 177 ± 33 166 ± 19 170 ± 28 −1.3 (−7.8, 5.2) 0.82 
 CGM-measured % in range 70–180 mg/dL (3.9–10 mmol/L), mean ± SD 55 ± 16 53 ± 16 64 ± 11 57 ± 14 4.8 (1.4, 8.3) 0.0074 
 CGM-measured % in range 3.9–7.8 mmol/L (70–140 mg/dL), mean ± SD 34 ± 14 32 ± 14 39 ± 10 35 ± 12 3.0 (0, 6.0) 0.1047 
 CGM-measured CV (%), median (IQR) 39 (34, 44) 39 (35, 43) 37 (34, 41) 38 (35, 42)   
  Mean ± SD 39 ± 7 39 ± 7 37 ± 5 38 ± 5 −1.0 (−2.5, 0.5) 0.67 
Hyperglycemia       
 CGM-measured % above 250 mg/dL (13.9 mmol/L), median (IQR) 13.5 (5.0, 23.7) 13.9 (6.8, 26.6) 10.9 (5.3, 15.7) 11.3 (5.0, 17.3)   
  Mean ± SD 15.4 ± 11.8 17.5 ± 12.8 11.2 ± 7.4 13.7 ± 11.4 −1.2 (−4.0, 1.6) 0.82 
 CGM-measured % above 300 mg/dL (16.7 mmol/L), median (IQR) 4.4 (1.3, 12.3) 5.7 (1.5, 12.0) 3.4 (1.5, 6.1) 3.2 (1.1, 6.9)   
  Mean ± SD 6.8 ± 6.6 8.0 ± 8.2 4.4 ± 4.2 5.7 ± 7.1 −0.4 (−2.1, 1.3) 0.82 
 CGM-measured HBGI, median (IQR) 9.1 (5.6, 13.5) 9.6 (6.6, 14.0) 8.2 (5.9, 9.9) 8.6 (6.1, 10.6)   
  Mean ± SD 9.9 ± 5.0 10.8 ± 5.6 8.2 ± 3.3 9.3 ± 4.9 −0.6 (−1.7, 0.6) 0.82 

CV, coefficient of variation; HBGI, high BG index; NA, not applicable.

Excludes one participant from the CLC group and one participant from the SAP group who dropped out postrandomization and did not have any data 3–13 weeks postrandomization to be included in analyses. The baseline CGM data for another CLC participant were unavailable, so their follow-up CGM data were included in both models using the direct likelihood method.

Adjusted for baseline values, age, prior CGM use, and clinical center (random effects). P values and CIs adjusted for multiplicity using the false discovery rate, with 0.10 as the threshold for statistical significance.

a

At least 15 consecutive min <70 mg/dL.

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