Skip to Main Content
Table 1

Overview of the study outcomes at each visit

MonthChangeend-baselineP value
036912
Days from baseline 0± 0 103 ± 25 193 ± 27 289 ± 28 392 ± 33   
HbA1c, mmol/mol 76.0 ± 12.5 69.8 ± 11.7 64.0 ± 11.4 62.6 ± 13.5 61.8 ± 11.4 −14.4 (−17.4; −10.5) <0.0001 
HbA1c, % 9.1 ± 1.1 8.5 ± 1.1 8.0 ± 1.0 7.9 ± 1.2 7.8 ± 1.04 −1.3 (−1.6; −0.96)  
UACR*, mg/g 95.8 ± 3.7 93.5 ± 3.5 70.1 ± 4.4 65.6 ± 4.0 76.3 ± 3.8 −15 (−38; 17) 0.049 
MAP, mmHg 98.9 ± 9.7 96.2 ± 14.0 94.3 ± 11.9 96.6 ± 9.8 97.9 ± 12.4 −1.9 (−6.3; 2.5) 0.90 
BMI, kg/m2 27.5 ± 5.1 27.6 ± 5.5 27.7 ± 5.1 27.5 ± 5.2 27.4 ± 5.6 0.3 (−0.2; 0.7) 0.18 
CGM uploads, N 26 24 24 25 22   
CGM readings, % 81 ± 31 63 ± 30 55 ± 20 61 ± 32 78 ± 51   
CGM readings, h 116 ± 45 961 ± 462 1,717 ± 623 1,403 ± 732 1,938 ± 1,267   
%TAR2 18 ± 13 15 ± 12 11.4 ± 8.7 11.5 ± 10 9.0 ± 7.7 −7.0 (−10.9; −3.3) 0.002 
%TAR1 42.3 ± 16.9 49.7 ± 19.4 42.5 ± 17.2 38.8 ± 18.2 32.3 ± 14.4 −7.4 (−12.9; −1.9) <0.0001 
%TIR 46.9 ± 20.1 47.1 ± 19.0 53.5 ± 20.0 57.9 ± 19.9 64.3 ± 13.4 13.2 (6.2; 20.2) 0.0003 
%TBR1 10.7 ± 12.5 3.2 ± 9.8 4.0 ± 11.4 3.3 ± 5.1 3.4 ± 2.6 −6.3 (−11.1; −1.6) 0.008 
%TBR2 3.3 ± 3.8 0.2 ± 0.3 0.3 ± 0.3 0.4 ± 0.4 0.6 ± 0.7 −2.7 (−3.8; −1.9) <0.0001 
MeanSG, mmol/L 9.6 ± 1.8 10.3 ± 1.6 9.7 ± 1.4 9.4 ± 1.6 8.9 ± 1.3 −0.5 (−1.02; −0.03) 0.0001 
SDSG, mmol/L 4.0 ± 1.0 3.2 ± 0.5 3.1± 0.4 3.2 ± 0.5 3.2 ± 0.6 −0.7 (−1.0; −0.4) <0.0001 
CVSG, % 41.9 ± 8.4 31.1 ± 3.9 32.4 ± 3.7 34.2 ± 3.6 36.3 ± 4.6 −5.6 (−8.1; −3.1) <0.0001 
GMISG, mmol/mol 58.0 ± 8.2 61.2 ± 7.6 58.2 ± 6.5 57.0 ± 7.3 54.4 ± 6.0 −2.5 (−4.8; −0.1) 0.0001 
MonthChangeend-baselineP value
036912
Days from baseline 0± 0 103 ± 25 193 ± 27 289 ± 28 392 ± 33   
HbA1c, mmol/mol 76.0 ± 12.5 69.8 ± 11.7 64.0 ± 11.4 62.6 ± 13.5 61.8 ± 11.4 −14.4 (−17.4; −10.5) <0.0001 
HbA1c, % 9.1 ± 1.1 8.5 ± 1.1 8.0 ± 1.0 7.9 ± 1.2 7.8 ± 1.04 −1.3 (−1.6; −0.96)  
UACR*, mg/g 95.8 ± 3.7 93.5 ± 3.5 70.1 ± 4.4 65.6 ± 4.0 76.3 ± 3.8 −15 (−38; 17) 0.049 
MAP, mmHg 98.9 ± 9.7 96.2 ± 14.0 94.3 ± 11.9 96.6 ± 9.8 97.9 ± 12.4 −1.9 (−6.3; 2.5) 0.90 
BMI, kg/m2 27.5 ± 5.1 27.6 ± 5.5 27.7 ± 5.1 27.5 ± 5.2 27.4 ± 5.6 0.3 (−0.2; 0.7) 0.18 
CGM uploads, N 26 24 24 25 22   
CGM readings, % 81 ± 31 63 ± 30 55 ± 20 61 ± 32 78 ± 51   
CGM readings, h 116 ± 45 961 ± 462 1,717 ± 623 1,403 ± 732 1,938 ± 1,267   
%TAR2 18 ± 13 15 ± 12 11.4 ± 8.7 11.5 ± 10 9.0 ± 7.7 −7.0 (−10.9; −3.3) 0.002 
%TAR1 42.3 ± 16.9 49.7 ± 19.4 42.5 ± 17.2 38.8 ± 18.2 32.3 ± 14.4 −7.4 (−12.9; −1.9) <0.0001 
%TIR 46.9 ± 20.1 47.1 ± 19.0 53.5 ± 20.0 57.9 ± 19.9 64.3 ± 13.4 13.2 (6.2; 20.2) 0.0003 
%TBR1 10.7 ± 12.5 3.2 ± 9.8 4.0 ± 11.4 3.3 ± 5.1 3.4 ± 2.6 −6.3 (−11.1; −1.6) 0.008 
%TBR2 3.3 ± 3.8 0.2 ± 0.3 0.3 ± 0.3 0.4 ± 0.4 0.6 ± 0.7 −2.7 (−3.8; −1.9) <0.0001 
MeanSG, mmol/L 9.6 ± 1.8 10.3 ± 1.6 9.7 ± 1.4 9.4 ± 1.6 8.9 ± 1.3 −0.5 (−1.02; −0.03) 0.0001 
SDSG, mmol/L 4.0 ± 1.0 3.2 ± 0.5 3.1± 0.4 3.2 ± 0.5 3.2 ± 0.6 −0.7 (−1.0; −0.4) <0.0001 
CVSG, % 41.9 ± 8.4 31.1 ± 3.9 32.4 ± 3.7 34.2 ± 3.6 36.3 ± 4.6 −5.6 (−8.1; −3.1) <0.0001 
GMISG, mmol/mol 58.0 ± 8.2 61.2 ± 7.6 58.2 ± 6.5 57.0 ± 7.3 54.4 ± 6.0 −2.5 (−4.8; −0.1) 0.0001 

The top portion shows mean ± SD of HbA1c, UACR, MAP, and BMI for each visit. The bottom portion shows the data for CGM (Enlite; Medtronic) as the number of participants with successful uploads; the percentage of CGM use for each observation period; percentage of %TIR (3.9–10.0 mmol/L), %TAR1 (>10.0 mmol/L), %TAR2 (>13.9 mmol/L), and %TBR1 (<3.9 mmol/L) as well as time in clinical hypoglycemia range (%TBR2: <3.0 mmol/L); and sensor glucose–calculated mean (MeanSG), SD (SDSG), CV (CVSG), and GMI (GMISG). Changes from baseline to study end are presented as mean (95% CI).

*

Three samples of morning spot urine were collected to quantify UACR by enzyme immunoassay. Presented UACR values are geometric means ± the antilogarithmic of the SD and changes in percentage.

Three blood pressures per visit were measured, and the last two systolic (SBP) and diastolic blood pressures (DBP) were averaged to calculate MAP: MAP = 1/3(SBP − DBP) + DBP. P values were calculated using a linear mixed model with participant-specific intercept as a random effect and time from baseline as a fixed effect.

Close Modal

or Create an Account

Close Modal
Close Modal