Table 2.
Comparison of Glycemic Metrics Between Groups at Baseline and at 12 Weeks
| Baseline |
12 Weeks |
Difference in unadjusted changes at 12 weeks (95 CI)a | P b | |||
|---|---|---|---|---|---|---|
| Intervention | Control | Intervention | Control | |||
| HbA1cc | ||||||
| HbA1c % | 9.0 (1.2) | 9.1 (1.4) | 9.0 (1.2) | 9.0 (1.3) | 0.23 (−0.21 to 0.67) | 0.3 |
| HbA1c (mmol/mol) | 74.7 (12.8) | 76.1 (14.8) | 75 (12.9) | 75 (14.6) | 2.5 (−2.32 to 7.32) | 0.3 |
| Glucose monitoring frequency (daily)d | ||||||
| Interstitial (intervention) versus capillary (control) | 4.7 (2.7) | 3.9 (2.2) | 8.9 (5.1) | 3.2 (1.6) | 4.89 (2.97 to 6.81) | <0.001) |
| Interstitial + capillary (intervention) versus capillary (control) | N/A | N/A | 10.7 (4.6) | 3.2 (1.6) | 6.77 (4.81 to 8.72) | <0.001) |
| Mean glucose mmol/L (SD) | 11.2 (2.0) | 11.6 (2.7) | 12.0 (1.7) | 11.5 (2.6) | −1.32 (−2.67 to 0.03) | 0.051 |
| Coefficient of variation % (SD) | 46.1 (8.5) | 46.5 (9.9) | 40.8 (4.7) | 46.9 (8.5) | 2.36 (−2.66 to 7.37) | 0.35 |
| TIR data | ||||||
| % Time in target: 3.9–10 mmol/L (70–180 mg/dL)e | 28.7 (16.6) | 27.3 (16) | 36.4 (13.2) | 25.1 (13) | 8.3 (Int) 3.0 (Control) (CI: −2.7 to 13.4) |
0.19 |
| % Time spent: <3.9 mmol/L (<70 mg/dL)f | 10.7 (11.3) | 10 (8.1) | 2.9 (2.8) | 10.6 (7.5) | −6.4 (Int) 1.0 (Control) (CI: −10.6 to −4.2) |
<0.001 |
| % Time spent above 10 mmol/L (180 mg/dL)g | 60.6 (18.8) | 62.2 (20.9) | 61.1 (13.3) | 64.3 (16.6) | −1.6 (Int) −3.8 (Control) (CI: −6.6 to 11.1) |
0.62 |
Data are mean (±SD) unless otherwise stated.
P -value based on HbA1c measurements recorded in millimoles per mole.
A negative value for estimated difference means that the reduction is greater in the intervention group. Adjusting for HbA1c, sex, and ethnicity made no meaningful or relevant difference to unadjusted reported outcomes as above.
P values are based on two-sample t-tests. A multinominal model, taking into account compositeness of the TIR, TAR, and TBR, gives similar CIs and P values.
Baseline capillary glucose checks from blood glucose meter 14-day summary (intervention group and control group). The 12-week capillary glucose checks were from FreeStyle Libre reader 14-day summary (intervention group) and blood glucose meter 14-day summary (control group). Difference in changes at 3 months was adjusted for sex and baseline HbA1c and incorporated baseline values as repeated measures.
The time in the target glucose range is the percentage of time with glucose level between 3.9 and 10.0 mmol/L (70–180 mg/dL). All participants before randomization by blinded FSL pro, from FreeStyle 2.0 reader 14-day summary in the intervention group and by blinded FSL pro in the control group.
Time below 3.9 mmol/mol is the percentage of time with blood glucose levels less than 73.9 mmol/L (70 mg/dL). All participants before randomization by blinded FSL pro, from FreeStyle 2.0 reader 14-day summary in the intervention group and by blinded FSL pro in the control group.
Time above 10 mmol/mol is the percentage of time with blood glucose levels above 10 mmol/mol 180 mg/dL (3.9 mmol/L). All participants before randomization by blinded FSL pro, from FreeStyle 2.0 reader 14-day summary in the intervention group and by blinded FSL pro in the control group.
TIR, time in range.