Table 3.
Outcome descriptive statistics and effect estimates (Incidence rate ratios (IRR) from a three-level random intercept negative binomial model) with 95% Confidence intervals, for HARPdoc vs BGAT for primary and secondary endpoint data: hypoglycaemia episodes. Significance level of 0.025 (two sided) for primary outcome.
| HARPdoc baseline | BGAT baseline | HARPdoc 12 months | BGAT 12 months | IRR [95% CI] | p | HARPdoc 24 months | BGAT 24 months | IRR [95% CI] | p | |
|---|---|---|---|---|---|---|---|---|---|---|
| Primary outcome measure | ||||||||||
| Severe hypoglycaemia (SH) episodes in last 12 months M | N = 49 | N = 50 | N = 42 | N = 45 | 1.25 | 0.62 | N = 41 | N = 42 | 1.26 | 0.64 |
| Median(IQR) | 5.0 (2.0–11.0) | 5.0 (2.0–12.0) | 1.0 (0.0–6.0) | 1.0 (0.0–5.0) | [0.51, 3.09] | 1.0 (0.0–2.0) | 0.0 (0.0–2.0) | [0.48, 3.35] | ||
| Primary data from open form, n (%) | 5 (10.2) | 4 (8.0) | 10 (23.8) | 16 (35.6) | 4 (9.8) | 10 (23.8) | ||||
| Secondary outcome measures | ||||||||||
| Loss of consciousness or seizure | N = 45 | N = 46 | N = 32 | N = 29 | 0.80 | 0.73 | N = 37 | N = 32 | 1.58 | 0.48 |
| Median (IQR) | 0.0 (0.0–2.0) | 1.0 (0.0–3.0) | 0.0 (0.0–1.0) | 0.0 (0.0–2.0) | [0.23,2.84] | 0.0 (0.0–1.0) | 0.0 (0.0–0.0) | [0.44, 5.66] | ||
| Glucagon or IV glucose | N = 44 | N = 45 | N = 32 | N = 29 | 0.69 | 0.58 | N = 37 | N = 32 | 1.73 | 0.42 |
| Median (IQR) | 0.0 (0.0–2.5) | 0.0 (0.0–1.0) | 0.0 (0.0–1.0) | 0.0 (0.0–1.0) | [0.18,2.59] | 0.0 (0.0–1.0) | 0.0 (0.0–0.0) | [0.46,6.57] | ||
| Ambulance call out | N = 44 | N = 46 | N = 32 | N = 29 | 0.46 | 0.19 | N = 37 | N = 32 | 2.67 | 0.15 |
| Median (IQR) | 0.0 (0.0–0.0) | 0.0 (0.0–1.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | [0.14,1.46] | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | [0.71,10.00] | ||
| A and E attendance | N = 45 | N = 46 | N = 32 | N = 29 | 2.21 | 0.48 | N = 37 | N = 32 | 1.17 | 0.90 |
| Median (IQR) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | [0.24,20.26] | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | [0.09,15.10] | ||
| Hospital admission | N = 45 | N = 46 | N = 32 | N = 29 | Unable to analyse due to low number of events | N = 37 | N = 32 | Unable to analyse due to low number of events | ||
| Median (IQR) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | ||||
| Moderate hypoglycaemia, episodes in last 4 weeks, total | N = 47 | N = 47 | N = 41 | N = 41 | 1.03 | 0.93 | N = 34 | N = 36 | 1.01 | 0.97 |
| Median (IQR) | 5.0 (2.0–8.0) | 10.0 (3.0–19.0) | 3.0 (2.0–10.0) | 5.0 (2.0–10.0) | [0.52,2.04] | 3.0 (1.0–9.0) | 4.0 (1.0–10.5) | [0.49,2.30] |
BGAT Blood Glucose Awareness Training, HARPdoc Hypoglycaemia Awareness Restoration Programme for people with T1D and problematic hypoglycaemia despite optimised control, N number of participants with data.