| |
Intervention arm
|
Standard care arm
|
Intervention effect (95% C.I)
|
P-value
|
|---|
| |
Baseline
|
Final visit
|
Baseline
|
Final visit
| | |
|
Primary outcome
| | | | | | |
|
Days correct dose taken (SD) (%)*
|
-
|
77.4 (26.3)a
| |
69.0 (30.8)b
|
8.4 (0.2, 16.7) c
|
0.044
|
|
Secondary outcomes
| | | | | | |
|
SF12 Physical (SD) †
|
43.3 (11.2) r
|
44.6 (11.1) c
|
45.5 (10.3) r
|
46.3 (9.0) l
|
-0.7 (-2.7, 1.4) s
|
0.52
|
|
SF12 Mental (SD) †
|
48.0 (10.6)
|
49.5 (10.4) c
|
50.0 (9.63) t
|
52.6 (8.8)l
|
-1.6 (-3.9, 0.6) s
|
0.15
|
|
Diabetes treatment satisfaction (SD)
|
-
|
30.6 (5.4) c
|
-
|
31.3 (4.6) f
|
-0.7 (-2.2, 0.7) u
|
0.32
|
|
HbA1c % (SD) †
|
8.34 (1.26) k
|
8.34 (1.24) k
|
8.29 (1.23) l
|
8.21 (1.32) f
|
0.06 (-0.19, 0.32) m
|
0.64
|
|
HbA1c mmol/l (SD)
|
67.7 (13.8)
|
67.7 (13.6)
|
67.1(13.4)
|
66.2 (14.4)
|
0.7 (- 2.1, 3.5)
| |
|
Medication-related
| | | | | | |
|
MARS Self report adherence (SD) †
|
23.6 (2.3) d
|
23.6 (2.6) e
|
23.6 (2.8) f
|
24.1 (1.6) g
|
-0.4 (-1.0, 0.2) h
|
0.20
|
|
Satisfaction with communication (median, IQR)**
| |
4 (2,5)
| |
4 (2,5)
| |
0.13
|
|
% reporting hypoglycaemia (N)***
| |
1.6% (2)
| |
0,0 (0)
| |
0.52*
|
- Values are mean (SD) unless otherwise stated. Missing values: a = 13, b = 4, c = 17, d = 15, e = 27, f = 8, g = 12, h = 39, k = 16, l = 9, m = 24, r = 1, s = 26, t = 2, u = 25.
- * - Estimate of intervention effect adjusted for baseline where available and 95% confidence interval derived from the non-parametric bootstrap percentile method with 50,000 replications. † = In the analysis of the final visit measure adjusting for a baseline that has occasional missing data, the missing indicator method is used. ** p value from Mann–Whitney test., *** p value from Fisher’s exact test. MARS Medication Adherence Report Scale.
