Table 4.
Outcome descriptive statistics and effect estimates (mean difference/odds ratio [OR] from a three-level random intercept linear/logistic regression model) with 95% Confidence intervals, for HARPdoc vs BGAT for secondary endpoint data: other glucose-related outcomes. p values for significance <0.05 or <0.025 with correction for multiple comparisons (Bonferoni), two sided.
| HARPdoc Baseline | BGAT Baseline | HARPdoc 12 months | BGAT 12 months | Estimated mean difference [95% CI] | p | HARPdoc 24 months | BGAT 24 months | Estimated mean difference [95% CI] | p | |
|---|---|---|---|---|---|---|---|---|---|---|
| Gold scores | N = 48 | N = 49 | N = 41 | N = 45 | −0.48 | 0.11 | N = 39 | N = 40 | −0.27 | 0.37 |
| Mean ± sd | 5.5 ± 1.1 | 5.1 ± 1.2 | 4.2 ± 1.5 | 4.3 ± 1.8 | [−1.07,0.11] | 3.8 ± 1.6 | 3.9 ± 1.9 | [−0.87,0.33] | ||
| Clarke scores | N = 48 | N = 50 | N = 41 | N = 45 | −0.10 | 0.72 | N = 39 | N = 41 | 0.28 | 0.33 |
| Mean ± sd | 5.6 ± 0.8 | 5.2 ± 1.2 | 4.5 ± 1.4 | 4.4 ± 1.6 | [−0.66,0.46] | 4.3 ± 1.6 | 3.8 ± 1.7 | [−0.29,0.85] | ||
| Glycated Haemoglobin % | N = 48 | N = 50 | N = 41 | N = 43 | N = 35 | N = 41 | ||||
| Mean ± sd | 7.4 ± 1.1 | 7.4 ± 1.3 | 7.3 ± 1.1 | 7.5 ± 1.0 | 7.4 ± 1.0 | 7.5 ± 1.3 | ||||
| Glycated haemoglobin mmol/mol | N = 48 | N = 50 | N = 41 | N = 43 | −0.05 | 0.69 | N = 35 | N = 41 | −0.10 | 0.47 |
| Mean ± sd | 57.1 ± 12.2 | 57.4 ± 14.1 | 56.7 ± 11.8 | 58.0 ± 11.2 | [−0.30,0.20] | 56.8 ± 10.9 | 57.9 ± 14.3 | [−0.38,0.17] | ||
| OR [95% CI] | OR [95% CI] | |||||||||
| Those with HbA1c rise ≤0.3%, | N = 41 | N = 43 | 1.26 | 0.78 | N = 35 | N = 34 | 4.94 | 0.11 | ||
| n (%) | 28 (68.3) | 28 (65.1) | [0.25,6.29] | 28 (80.0) | 22 (64.7) | [0.70,34.72] |
BGAT Blood Glucose Awareness Training, HARPdoc Hypoglycaemia Awareness Restoration Programme for people with T1D and problematic hypoglycaemia despite optimised control, n number; N number of participants with data.