Table 6.
Outcome descriptive statistics and effect estimates (mean difference from a three-level random intercept linear regression model) with 95% Confidence intervals for HARPdoc vs BGAT for secondary endpoint data: cognitive outcomes (the Attitudes to Awareness questionnaire, A2A) and worry and behaviours (Hypoglycaemia Fear Score II (HFS-II) and Hyperglycaemia Avoidance Survey (HAS)).
| HARPdoc baseline | BGAT baseline | HARPdoc 12 month | BGAT 12 month | Estimated mean difference [95% CI] | p | HARPdoc 24 month | BGAT 24 month | Estimated mean difference [95% CI] | p | |
|---|---|---|---|---|---|---|---|---|---|---|
| A2A Factor: Hyperglycaemia Avoidance Prioritised | N = 47 | N = 50 | N = 42 | N = 44 | 0.08 | 0.07 | N = 37 | N = 40 | −1.06 | 0.02 |
| Mean ± SD | 6.1 ± 2.9 | 5.6 ± 2.5 | 4.6 ± 2.9 | 5.1 ± 2.3 | [−1.67,0.08] | 4.0 ± 2.5 | 4.9 ± 2.1 | [−1.97,−0.14] | ||
| A2A Factor: Hypoglycaemia Concern Minimised | N = 47 | N = 50 | N = 42 | N = 44 | −0.21 | 0.51 | N = 37 | N = 40 | −0.62 | 0.06 |
| Mean ± SD | 2.5 ± 2.0 | 2.4 ± 1.7 | 2.2 ± 1.5 | 2.4 ± 1.7 | [−0.82,0.40] | 1.9 ± 1.5 | 2.7 ± 2.0 | [−1.26,0.03] | ||
| A2A Factor: Asymptomatic Hypoglycaemia Normalised | N = 47 | N = 50 | N = 42 | N = 44 | −0.50 | 0.13 | N = 37 | N = 40 | −0.35 | 0.31 |
| Mean ± SD | 2.1 ± 2.5 | 1.4 ± 1.8 | 0.9 ± 1.5 | 1.2 ± 1.9 | [−1.15,0.14] | 1.1 ± 1.6 | 1.3 ± 1.7 | [−1.03,0.33] | ||
| A2A total score | N = 47 | N = 50 | N = 42 | N = 44 | −1.56 | 0.03 | N = 37 | N = 40 | −2.07 | 0.01 |
| Mean ± SD | 10.8 ± 6.2 | 9.3 ± 4.6 | 7.6 ± 4.6 | 8.7 ± 4.4 | [−3.00.−0.13] | 7.1 ± 4.2 | 8.9 ± 3.4 | [−3.57,−0.56] | ||
| HFS-II Behaviour subscale | N = 47 | N = 50 | N = 41 | N = 44 | −0.18 | 0.10 | N = 36 | N = 40 | −0.05 | 0.69 |
| Mean ± SD | 1.5 ± 0.8 | 1.4 ± 0.8 | 1.2 ± 0.8 | 1.4 ± 0.8 | [−0.40,0.03] | 1.2 ± 0.8 | 1.4 ± 0.8 | [−0.27, 0.18] | ||
| HFS-II Worry subscale | N = 47 | N = 50 | N = 42 | N = 44 | 0.003 | 0.98 | N = 361 | N = 40 | 0.08 | 0.54 |
| Mean ± SD | 1.7 ± 0.9 | 1.7 ± 1.0 | 1.5 ± 0.7 | 1.5 ± 1.0 | [−0.23,0.24] | .2 ± 0.8 | 1.3 ± 1.0 | [−0.17,0.33] | ||
| HFS-II Total score | N = 47 | N = 50 | N = 41 | N = 44 | −0.08 | 0.45 | N = 36 | N = 40 | 0.03 | 0.77 |
| Mean ± SD | 1.6 ± 0.8 | 1.6 ± 0.8 | 1.4 ± 0.7 | 1.5 ± 0.8 | [−0.27,0.12] | 1.2 ± 0.7 | 1.4 ± 0.9 | [−0.17,0.23] | ||
| HAS Behaviour Subscale | N = 46 | N = 50 | N = 42 | N = 44 | −0.16 | 0.09 | N = 37 | N = 38 | −0.07 | 0.46 |
| Mean + SD | 1.8 ± 0.6 | 1.8 ± 0.6 | 1.5 ± 0.6 | 1.7 ± 0.6 | [−0.35,0.03] | 1.5 ± 0.5 | 1.5 ± 0.5 | [−0.27,−0.12] | ||
| HAS Worry Subscale | N = 47 | N = 50 | N = 42 | N = 44 | −0.19 | 0.09 | N = 37 | N = 40 | −0.23 | 0.05 |
| Mean ± SD | 2.0 ± 0.7 | 1.9 ± 0.6 | 1.7 ± 0.7 | 1.9 ± 0.7 | [−0.41,0.03] | 1.7 ± 0.7 | 1.9 ± 0.6 | [−0.46, −0.003] | ||
| HAS total score | N = 46 | N = 50 | N = 42 | N = 44 | −0.18 | 0.05 | N = 37 | N = 39 | −0.16 | 0.11 |
| Mean ± SD | 1.9 ± 0.5 | 1.9 ± 0.5 | 1.6 ± 0.6 | 1.8 ± 0.5 | [−0.37,−0.0009] | 1.6 ± 0.5 | 1.7 ± 0.5 | [−0.35,0.04] |
P values for significance, <0.05, <0.025 with correction for multiple comparisons, two sided. N = number of participants with data.