Table 2.
Glycemic Outcomes
| CLC (n = 40) |
SAP (n = 23) |
|
|
|||
|---|---|---|---|---|---|---|
| Baseline | 26 Weeks | Baseline | 26 Weeks | CLC-SAP difference (95% CI)a | Pa | |
| CGM metrics | ||||||
| % TIR 70–180 mg/dL | 51 (16) | 64 (8) | 53 (13) | 52 (14) | 13 (9 to 16) | <0.0001 |
| Mean glucose, mg/dL | 183 (31) | 167 (15) | 179 (25) | 183 (28) | −18 (−25 to −10) | <0.0001 |
| % Time >180 mg/dL | ||||||
| Median (IQR) | 44 (32, 54) | 33 (28, 40) | 43 (33, 56) | 45 (33, 54) | ||
| Mean (SD) | 46 (17) | 34 (8) | 44 (14) | 46 (15) | −12 (−16 to −8) | <0.0001 |
| % Time >250 mg/dL | ||||||
| Median (IQR) | 15.1 (9.1, 26.0) | 9.5 (6.3, 14.1) | 14.7 (6.9, 22.7) | 14.2 (10.6, 25.9) | ||
| Mean (SD) | 18.3 (13.3) | 10.9 (6.5) | 16.0 (10.7) | 18.1 (12.2) | −8.1 (−11.7 to −4.5) | <0.0001 |
| % Time >300 mg/dL | ||||||
| Median (IQR) | 4.8 (2.7, 12.8) | 3.1 (1.4, 5.7) | 5.1 (1.2, 10.4) | 5.1 (3.1, 11.8) | ||
| Mean (SD) | 8.3 (8.2) | 4 (3.8) | 6.5 (6.6) | 7.9 (7.9) | −4.4 (−6.7 to −2.1) | 0.0005 |
| CGM-measured hyperglycemic eventb rate per week | ||||||
| Median (IQR) | 4.3 (2.6, 7.0) | 2.6 (1.6, 4.5) | 4.5 (1.1, 7.0) | 4.4 (3.3, 7.4) | ||
| Mean (SD) | 4.8 (3.) | 3.3 (2.2) | 4.5 (3.3) | 5.0 (3.0) | −1.9 (−2.9 to −1.0) | <0.0001 |
| % Time <70 mg/dL | ||||||
| Median (IQR) | 3.1 (0.7, 4.6) | 1.4 (0.8, 2.3) | 2.1 (1.0, 4.6) | 1.8 (0.7, 3.0) | ||
| Mean (SD) | 3.2 (2.7) | 1.6 (1.0) | 2.9 (2.5) | 2.1 (1.5) | −0.7 (−1 to −0.2) | 0.002 |
| % Time <54 mg/dL | ||||||
| Median (IQR) | 0.4 (0.1, 1.3) | 0.2 (0.1, 0.4) | 0.2 (0.1, 0.7) | 0.3 (0.1, 0.5) | ||
| Mean (SD) | 0.9 (1.1) | 0.3 (0.3) | 0.7 (1.0) | 0.4 (0.3) | −0.09 (−0.2 to 0.05) | 0.21 |
| CGM-measured hypoglycemic eventc rate per week | ||||||
| Median (IQR) | 0.6 (0.0, 2.2) | 0.5 (0.2, 1.0) | 0.5 (0.0, 1.5) | 0.5 (0.2, 0.8) | ||
| Mean (SD) | 1.3 (1.6) | 0.7 (0.6) | 1.1 (1.6) | 0.7 (0.8) | −0.2 (−0.5 to 0.2) | 0.31 |
| Coefficient of variation, % | 39 (7) | 37 (4) | 38 (6) | 38 (5) | −2 (−3 to 0) | 0.02 |
| CGM binary outcomes | ||||||
| Participants with TIR 70–180 mg/dL >70% | 2 (5%) | 12 (30%) | 2 (9%) | 3 (13%) | 22 (−6 to 44) | 0.06 |
| Participants with time <54 mg/dL <1% | 26 (65%) | 38 (95%) | 19 (83%) | 21 (91%) | 9 (−32 to 44) | 0.32 |
| Participants with TIR 70–180 mg/dL >70% and time <54 mg/dL <1% | 1 (3%) | 12 (30%) | 2 (9%) | 3 (13%) | 22 (−6 to 44) | 0.06 |
| HbA1c outcomes | ||||||
| Mean HbA1c, % [mmol/mol] | 7.97 (0.93) [64 (10.20)] | 7.51 (0.74) [59 (8.1)] | 7.66 (0.86) [60 (9.4)] | 7.66 (1.14)d [60 (12.5)] | −0.30 (−0.67 to 0.08) [−3.3 (−7.3 to 0.9)] | 0.13 |
| Participants with HbA1c ≤ 7.0% | 4 (10%) | 8 (20%) | 5 (22%) | 5 (23%)d | 6 (−24 to 27) | 0.45 |
| Participants with HbA1c improvement from baseline ≥0.5% | NA | 15 (38%) | NA | 5 (23%)d | 13 (−18 to 39) | 0.34 |
Mean (SD), n (%), or median (IQR).
a
Adjusted for baseline value of dependent variable, age, prior CGM use, prior pump use, and clinical center (random effects). P values and confidence intervals adjusted for multiplicity using the false discovery rate.
b
At least 15 consecutive minutes >300 mg/dL (>16.6 mmol/L).
c
At least 15 consecutive minutes <54 mg/dL (<3.0 mmol/L).
d
For one participant in control group, the 26-week visit was outside the prespecified window, thus their HbA1c value was excluded from analyses.
TIR, time in range.