Within-trial cost-effectiveness results
| . | Control (n = 53) . | CGM (n = 103) . | . | ||
|---|---|---|---|---|---|
| . | Mean (SD) . | Median (range or IQR) . | Mean (SD) . | Median (range or IQR) . | |
| Utility and QALYs | P valueb | ||||
| Utility change from baseline | 0.0 (0.08) | 0 (−0.27, 0.26) | −0.01 (0.09) | 0 (−0.33, 0.32) | 0.78 |
| QALYs | 0.46 (0.06) | 0.47 (0.13, 0.50) | 0.46 (0.05) | 0.47 (0.24, 0.50) | 0.61 |
| Costs, $ | P valueb | ||||
| Total direct costs | 3,118 (3,120) | 2,565 (1,928, 3,277) | 5,336 (3,070) | 5,092 (4,485, 5,726) | <0.01 |
| Direct trial personnel | 96 (205) | 47 (0, 94) | 60 (77) | 47 (0, 94) | 0.41 |
| Medical care | 3,022 (3,088) | 2,478 (1,880, 3,122) | 2,921 (3,065) | 2,509 (1,909, 3,095) | 0.86 |
| CGM | 0 (0) | 0 | 2,554 (0) | 2,554 | <0.01 |
| Total indirect costsa | 36 (121) | 0 (0, 0) | 54 (314) | 0 (0, 0) | 0.85 |
| Missed work | 26 (101) | 0 (0, 0) | 36 (307) | 0 (0, 0) | 0.65 |
| Poor performance | 10 (40) | 0 (0, 0) | 18 (70) | 0 (0, 0) | 0.63 |
| Self-management | 4,012 (5,529) | 2,829 (0, 5,610) | 5,473 (10,300) | 2,829 (2,259, 5,658) | 0.86 |
| Total costs | 7,236 (6,097) | 5,287 (4,586, 8,223) | 11,200 (11,300) | 8,178 (6,864, 10,300) | <0.01 |
| Total costsa | 3,154 (3,122) | 2,565 (1,999, 3,513) | 5,593 (3,083) | 5,105 (4,496, 5,780) | <0.01 |
| Clinical outcomes: reduction from baseline | P valueb | ||||
| HbA1c | −0.39 (0.70) | −0.30 (−3.20, 0.90) | −0.99 (0.77) | −1.00 (−3.00, 0.70) | <0.01 |
| Daily strip tests | 0.1 (1.5) | 0 (−4, 3) | −0.5 (1.5) | 0 (−5, 3) | 0.04 |
| Insulin dose | 1.0 (11) | 1 (−23, 25) | −2.3 (22) | 0 (−145, 52) | 0.31 |
| Daily rate of NSHEs | −0.06 (0.27) | 0 (−0.93, 0.47) | −0.12 (0.29) | −0.08 (−1.07, 0.63) | 0.02c |
| BMI | 0.27 (1.07) | 0.15 (−2.22, 2.80) | 0.59 (1.38) | 0.56 (−3.42, 5.28) | 0.16 |
| Patients having severe hyperglycemic events, n (%) | 1 (2) | 0 (0) | 0.34 | ||
| Patients having severe hypoglycemic events, n (%) | 2 (4) | 2 (2) | 0.6 | ||
| Subgroup analyses: reduction from baseline | P valuec | ||||
| In the subgroup with high baseline HbA1c (≥8.5%) | |||||
| HbA1c | −0.53 (0.60) | −0.50 (−1.5, 0.8) | −1.29 (0.77) | −1.30 (−3, 0.3) | 0.02 |
| Daily rate of NSHEs | −0.10 (0.29) | −0.07 (−0.93, 0.47) | −0.08 (0.27) | −0.07 (−1.03, 0.63) | 0.27 |
| In the subgroup with low baseline HbA1c (<8.5%) | |||||
| HbA1c | −0.22 (0.78) | −0.10 (−3.20, 0.90) | −0.63 (0.59) | −0.60 (−1.80, 0.70) | 0.01 |
| Daily rate of NSHEs | −0.02 (0.25) | 0.01 (−0.86, 0.32) | −0.17 (0.32) | −0.14 (−1.07, 0.44) | 0.03 |
| . | Control (n = 53) . | CGM (n = 103) . | . | ||
|---|---|---|---|---|---|
| . | Mean (SD) . | Median (range or IQR) . | Mean (SD) . | Median (range or IQR) . | |
| Utility and QALYs | P valueb | ||||
| Utility change from baseline | 0.0 (0.08) | 0 (−0.27, 0.26) | −0.01 (0.09) | 0 (−0.33, 0.32) | 0.78 |
| QALYs | 0.46 (0.06) | 0.47 (0.13, 0.50) | 0.46 (0.05) | 0.47 (0.24, 0.50) | 0.61 |
| Costs, $ | P valueb | ||||
| Total direct costs | 3,118 (3,120) | 2,565 (1,928, 3,277) | 5,336 (3,070) | 5,092 (4,485, 5,726) | <0.01 |
| Direct trial personnel | 96 (205) | 47 (0, 94) | 60 (77) | 47 (0, 94) | 0.41 |
| Medical care | 3,022 (3,088) | 2,478 (1,880, 3,122) | 2,921 (3,065) | 2,509 (1,909, 3,095) | 0.86 |
| CGM | 0 (0) | 0 | 2,554 (0) | 2,554 | <0.01 |
| Total indirect costsa | 36 (121) | 0 (0, 0) | 54 (314) | 0 (0, 0) | 0.85 |
| Missed work | 26 (101) | 0 (0, 0) | 36 (307) | 0 (0, 0) | 0.65 |
| Poor performance | 10 (40) | 0 (0, 0) | 18 (70) | 0 (0, 0) | 0.63 |
| Self-management | 4,012 (5,529) | 2,829 (0, 5,610) | 5,473 (10,300) | 2,829 (2,259, 5,658) | 0.86 |
| Total costs | 7,236 (6,097) | 5,287 (4,586, 8,223) | 11,200 (11,300) | 8,178 (6,864, 10,300) | <0.01 |
| Total costsa | 3,154 (3,122) | 2,565 (1,999, 3,513) | 5,593 (3,083) | 5,105 (4,496, 5,780) | <0.01 |
| Clinical outcomes: reduction from baseline | P valueb | ||||
| HbA1c | −0.39 (0.70) | −0.30 (−3.20, 0.90) | −0.99 (0.77) | −1.00 (−3.00, 0.70) | <0.01 |
| Daily strip tests | 0.1 (1.5) | 0 (−4, 3) | −0.5 (1.5) | 0 (−5, 3) | 0.04 |
| Insulin dose | 1.0 (11) | 1 (−23, 25) | −2.3 (22) | 0 (−145, 52) | 0.31 |
| Daily rate of NSHEs | −0.06 (0.27) | 0 (−0.93, 0.47) | −0.12 (0.29) | −0.08 (−1.07, 0.63) | 0.02c |
| BMI | 0.27 (1.07) | 0.15 (−2.22, 2.80) | 0.59 (1.38) | 0.56 (−3.42, 5.28) | 0.16 |
| Patients having severe hyperglycemic events, n (%) | 1 (2) | 0 (0) | 0.34 | ||
| Patients having severe hypoglycemic events, n (%) | 2 (4) | 2 (2) | 0.6 | ||
| Subgroup analyses: reduction from baseline | P valuec | ||||
| In the subgroup with high baseline HbA1c (≥8.5%) | |||||
| HbA1c | −0.53 (0.60) | −0.50 (−1.5, 0.8) | −1.29 (0.77) | −1.30 (−3, 0.3) | 0.02 |
| Daily rate of NSHEs | −0.10 (0.29) | −0.07 (−0.93, 0.47) | −0.08 (0.27) | −0.07 (−1.03, 0.63) | 0.27 |
| In the subgroup with low baseline HbA1c (<8.5%) | |||||
| HbA1c | −0.22 (0.78) | −0.10 (−3.20, 0.90) | −0.63 (0.59) | −0.60 (−1.80, 0.70) | 0.01 |
| Daily rate of NSHEs | −0.02 (0.25) | 0.01 (−0.86, 0.32) | −0.17 (0.32) | −0.14 (−1.07, 0.44) | 0.03 |
All costs data were summarized by interquartile range (IQR) and other continuous outcomes were summarized by range.
Bold P values indicate statistical significance (P < 0.05).
aBoth total indirect costs and total costs did not include the costs from diabetes self-management due to its 20% missing data and huge variability; that is, ∼20% patients reported unknown daily number of hours of self-management and seven patients from both groups reported ≥12 h/day and two of CGM users reported 24 h/day.
bP value was from the Wilcoxon rank sum test to compare the two groups.
cP value was from an ANCOVA model adjusting for its baseline outcome and site as a random effect.