Table 2.
Glycemic control
Fix group | Flex group | Group difference | |||||
---|---|---|---|---|---|---|---|
Baseline | Study | P | Baseline | Study | P | P | |
HbA1c | |||||||
% | 8.0 ± 2.1 | 6.8 ± 0.3 | 0.026 | 7.9 ± 1.5 | 6.6 ± 0.5 | 0.001 | 0.168 |
mmol/mol | 64 ± 26.2 | 51 ± 3.3 | 0.026 | 63 ± 18.6 | 49 ± 5.5 | 0.001 | 0.168 |
Sensor glucose, mg/dL | 174 ± 26 | 147 ± 23 | 0.002 | 168 ± 29 | 145 ± 18 | 0.005 | 0.804 |
CV, % | 35.6 ± 8.1 | 34.1 ± 5.0 | 0.520 | 30.1 ± 4.4 | 30.8 ± 4.2 | 0.634 | 0.045 |
Sensor glucose values in range, % | |||||||
<54 mg/dL | 0.2 ± 0.4 | 0.1 ± 0.3 | 1.000 | 0.8 ± 1.4 | 0.5 ± 0.3 | 0.275 | 0.167 |
54–70 mg/dL | 1.4 ± 0.5 | 1.5 ± 1.5 | 0.605 | 2.0 ± 1.5 | 2.7 ± 1.7 | 0.718 | 0.283 |
70–180 mg/dL | 47.5 ± 18.3 | 73.5 ± 6.7 | 0.001 | 49.1 ± 16.8 | 80.3 ± 7.4 | 0.001 | 0.043 |
180–250 mg/dL | 22.6 ± 8.1 | 19.0 ± 5.2 | 0.122 | 26.8 ± 8.2 | 13.5 ± 5.9 | 0.001 | 0.114 |
>250 mg/dL | 28.3 ± 15.9 | 5.7 ± 3.6 | 0.001 | 21.3 ± 11.8 | 3.0 ± 2.4 | 0.001 | 0.012 |
TDD, units/kg/day | 1.0 ± 0.6 | 1.1 ± 0.4 | 0.517 | 1.0 ± 0.6 | 1.1 ± 0.5 | 0.601 | 0.984 |
Basal insulin, % of TDD | 43.2 ± 6.7 | 34.2 ± 7.1 | 0.001 | 44.8 ± 5.9 | 32.6 ± 5.2 | 0.001 | 0.459 |
Weight, kg | 52.2 ± 12.7 | 53.5 ± 11.2 | 0.753 | 51.3 ± 10.7 | 52.4 ± 9.6 | 0.754 | 0.765 |
Data are mean ± SD. Study indicates 12 weeks of MiniMed 780G system use. CGM data at baseline were collected using the Guardian 4 sensor with the MiniMed 780G system for a 1-week period of training (no insulin delivery with pump).