Table 1.
Changes in primary and secondary outcome profiles during the study and comparisons between treatments
| Variable | RT-CGM (n = 10) | Blinded CGM (n = 10) | P value (ANCOVA) | ||||
|---|---|---|---|---|---|---|---|
| Baseline | 12 weeks | Change | Baseline | 12 weeks | Change | ||
| Glycaemic control | |||||||
| HbA1c (%) | 6.60 ± 0.86 | 5.90 ± 0.57 | − 0.67 ± 0.82 | 7.11 ± 0.80 | 6.43 ± 0.92 | − 0.68 ± 0.74 | 0.43 |
| MeSa | 1.01 ± 1.08 | 0.71 ± 0.72 | − 0.30 ± 0.59 | 1.19 ± 1.02 | 1.21 ± 0.98 | 0.02 ± 0.23 | 0.110 |
| Body weight and composition | |||||||
| Weight (kg) | 101.26 ± 15.03 | 93.85 ± 15.59 | − 7.41 ± 4.50 | 92.94 ± 15.51 | 87.49 ± 16.75 | − 5.45 ± 4.03 | 0.307 |
| Muscle mass (kg) | 33.36 ± 6.07 | 32.79 ± 6.34 | − 0.58 ± 0.95 | 32.43 ± 7.16 | 31.88 ± 7.44 | − 0.55 ± 0.86 | 0.881 |
| Body fat (kg) | 41.75 ± 11.29 | 35.18 ± 11.34 | − 6.57 ± 4.05 | 35.11 ± 6.21 | 30.51 ± 5.79 | − 4.60 ± 3.27 | 0.455 |
| Body fat (%) | 40.80 ± 7.60 | 37.00 ± 8.58 | − 3.80 ± 3.16 | 38.5 ± 5.46 | 35.1 ± 3.90 | − 3.40 ± 2.95 | 0.904 |
| Fat free mass (kg) | 59.5 ± 10.24 | 58.67 ± 10.65 | − 0.84 ± 1.55 | 57.83 ± 11.90 | 56.98 ± 12.29 | − 0.85 ± 1.38 | 0.956 |
| Lean trunk mass (kg) | 28.07 ± 4.41 | 26.97 ± 4.78 | − 1.10 ± 1.16 | 27.33 ± 5.14 | 26.49 ± 5.43 | − 0.84 ± 0.89 | 0.533 |
| Fat trunk mass (kg) | 21.50 ± 4.53 | 18.40 ± 5.23 | − 3.10 ± 2.43 | 18.93 ± 3.45 | 16.59 ± 3.38 | − 2.34 ± 1.71 | 0.524 |
| Cardiovascular risk markers | |||||||
| Fasting glucose (mmol/L) | 7.44 ± 1.35 | 6.27 ± 1.42 | − 1.17 ± 1.94 | 8.74 ± 1.92 | 7.77 ± 1.86 | − 0.97 ± 2.20 | 0.146 |
| Fasting insulin (mU/L) | 19.19 ± 8.65 | 14.93 ± 9.12 | − 4.26 ± 5.91 | 20.23 ± 7.37 | 17.77 ± 6.76 | − 2.46 ± 5.73 | 0.419 |
| Fasting insulin (pmol/L) | 132.26 ± 60.04 | 103.68 ± 63.37 | − 29.58 ± 41.08 | 140.49 ± 51.16 | 123.40 ± 46.93 | − 17.08 ± 39.82 | 0.419 |
| Serum TC (mmol/L) | 4.33 ± 1.32 | 4.29 ± 1.25 | − 0.04 ± 0.38 | 3.67 ± 0.49 | 3.41 ± 0.40 | − 0.26 ± 0.52 | 0.123 |
| Serum LDL-Cb (mmol/L) | 2.53 ± 1.08 | 2.46 ± 1.02 | − 0.07 ± 0.34 | 2.15 ± 0.41 | 1.89 ± 0.38 | − 0.26 ± 0.42 | 0.152 |
| Serum HDL-C (mmol/L) | 1.34 ± 0.16 | 1.41 ± 0.19 | 0.07 ± 0.26 | 1.10 ± 0.34 | 1.17 ± 0.36 | 0.07 ± 0.09 | 0.619 |
| Serum TAG (mmol/L) | 1.62 ± 0.65 | 1.30 ± 0.76 | − 0.32 ± 0.46 | 1.65 ± 0.72 | 1.29 ± 0.45 | − 0.36 ± 0.53 | 0.884 |
| Mean diastolic blood pressure (mg/Hg) | 76.70 ± 9.76 | 75.53 ± 8.00 | − 1.67 ± 7.24 | 76.87 ± 8.70 | 71.80 ± 7.42 | − 5.07 ± 6.28 | 0.152 |
| Mean systolic blood pressure (mg/Hg) | 133.40 ± 22.50 | 130.03 ± 12.79 | − 3.37 ± 17.71 | 130.93 ± 8.38 | 120.70 ± 11.10 | − 10.23 ± 12.96 | 0.099 |
| Physical activity (accelerometry) (9 intervention, 10 control) | |||||||
| % (Mean daily) time spent in sedentary behaviour | 87.4 ± 4.9 | 84.2 ± 5.8 | − 3.2 ± 2.2 | 88.4 ± 4.6 | 86.5 ± 4.7 | − 2.0 ± 1.7 | 0.329 |
| % (Mean daily) time spent in moderate/vigorous activity | 3.9 ± 2.2 | 5.4 ± 3.4 | 1.5 ± 1.8 | 3.3 ± 2.1 | 3.8 ± 2.3 | 0.5 ± 0.5 | 0.114 |
All values are mean ± SD unless otherwise stated. ANCOVA analysis was used to compare the change in each of the outcome measures at week 12, between the 2 groups using baseline measures as covariates
Total analysed n = 20 (RT-CGM 10, blinded CGM 10) unless otherwise stated
RT-CGM real-time continuous glucose monitoring, Blinded CGM blinded continuous glucose monitoring, HbA1c% glycated haemoglobin, MeS medication effect score, IQR interquartile range (median), TC total cholesterol, LDL-C low-density lipoprotein cholesterol, HDL-C high-density lipoprotein cholesterol, TAG triacylglycerol
aAnalyses were performed on natural log (MeS + 0.1) (P values), raw data reported
bAnalyses were performed on natural log transformed data (P values), raw data reported