Table 3.
Estimated Change From Baseline in HbA1c, Change From Baseline in Total Daily Dose, and CGM Metrics at the End of Treatment.
| Endpoint | Personal CGM | No CGM | Difference (95% CI) | P value |
|---|---|---|---|---|
| Change from baseline in HbA1c | −0.01% –0.06 mmol/mol |
−0.07% –0.74 mmol/mol |
0.06% (−0.03%; 0.16%) 0.68 (−0.37; 1.72) mmol/mol |
.2028 |
| Change from baseline in total daily insulin dose | −0.0033 U/kg | −0.0082 U/kg | 0.0049 (−0.0239; 0.0336) U/kg | .7394 |
| Time spent in hyperglycemia (>180 mg/dL [10.0 mmol/L]) | 41.1% 591.3 min |
41.2% 593.7 min |
−0.17% (−2.56%; 2.22%) −2.4 (−36.8; 32.0) min |
.8915 |
| Time spent in target (70 mg/dL [3.9 mmol/L] <CGM ≤180 mg/dL [10.0 mmol/L]) | 31.6% 455.5 min |
31.9% 458.7 min |
−0.22% (−2.01%; 1.57%) −3.2 (−29.0; 22.6) min |
.8055 |
| Time spent in hypoglycemia (≤70 mg/dL [3.9 mmol/L]) | 4.5% 67.2 min |
5.7% 82.4 min |
−1.05% (−1.79%; −0.32%)*
−15.2 (−28.8; −4.6) min* |
.0051 |
| Time spent in hypoglycemia (≤53 mg/dL [3.0 mmol/L]) | 1.7% 24.9 min |
2.3% 33.1 min |
−0.56% (−0.97%; −0.16%)*
−8.1 (−14.0; −2.2) min* |
.0070 |
| Coefficient of variation | 39.5% | 41.1% | −1.54% (−2.60%; −0.49%) * | .0043 |
| Mean interstitial glucose | 173.9 mg/dL | 172.8 mg/dL | 1.07 (−3.17; 5.30) mg/dL | .6213 |
Estimated means, differences, 95% confidence limits, and P value are from analysis of variance repeated-measures models adjusted for age, sex, region, smoking status, body mass index, diabetes duration, and value at baseline (HbA1c, total daily insulin dose, or CGM metric).
CGM, continuous glucose monitoring; HbA1c, glycated hemoglobin A1c.
*
Statistically significant.