Overview of the study outcomes at each visit
| . | Month . | Changeend-baseline . | P value . | ||||
|---|---|---|---|---|---|---|---|
| 0 . | 3 . | 6 . | 9 . | 12 . | |||
| 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 |
| . | Month . | Changeend-baseline . | P value . | ||||
|---|---|---|---|---|---|---|---|
| 0 . | 3 . | 6 . | 9 . | 12 . | |||
| 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.