Table 4.
Within and between-group change from workshop to end of study (15 months)
|
Group |
Descriptive statistics Mean (SD) |
Change at 15 months: Within-group p-value |
Change at 15 months: Between groups |
|||
---|---|---|---|---|---|---|---|
Workshop | Final | Adjusted mean (SE) | 95% CI | Between-group p-value | |||
HbA1c*,% |
I (n = 73) |
7.12 (0.42) |
7.09 (0.41) |
0.34 |
0.02 (0.04) |
(−0.05 to 0.09) |
0.63 |
C (n = 76) |
7.20 (0.52) |
7.15 (0.51) |
0.13 |
|
|
|
|
% patients HbA1c ≤ 7.0% |
I (n = 73) |
58.40 (16.20) |
58.68 (15.40) |
0.76 |
−1.22 (1.30) |
(−3.78 to 1.35) |
0.35 |
C (n = 76) |
55.95 (15.65) |
57.58 (16.12) |
0.15 |
|
|
|
|
FPG† level in mmol/L |
I (n = 71) |
7.86 (0.67) |
7.78 (0.68) |
0.13 |
0.01 (0.07) |
(−0.13 to 0.15) |
0.85 |
C (n = 70) |
7.89 (0.69) |
7.82 (0.68) |
0.22 |
|
|
|
|
% patients prescribed OAD‡ |
I (n = 73) |
80.87 (10.83) |
83.32 (9.98) |
< 0.001 |
0.87 (0.65) |
(−0.42 to 2.16) |
0.18 |
C (n = 76) |
79.24 (12.06) |
81.12 (11.14) |
< 0.001 |
|
|
|
|
OAD score§ |
I (n = 73) |
1.32 (0.20) |
1.37 (0.21) |
< 0.001 |
0.01 (0.02) |
(−0.03 to 0.04) |
0.65 |
C (n = 76) |
1.38 (0.21) |
1.41 (0.24) |
0.02 |
|
|
|
|
% patients prescribed insulin |
I (n = 73) |
11.53 (8.93) |
17.14 (10.64) |
< 0.001 |
−1.06 (0.88) |
(−2.80 to 0.69) |
0.23 |
C (n = 76) |
11.53 (8.51) |
18.38 (10.82) |
< 0.001 |
|
|
|
|
Insulin daily dose (units) |
I (n = 61) |
47.91 (21.24) |
53.64 (22.71) |
< 0.01 |
5.96 (2.83) |
(0.35 to 11.56) |
0.04 |
C (n = 57) |
57.19 (26.21) |
54.94 (23.65) |
0.30 |
|
|
|
|
Intensification of diabetes management** | I (n = 73) |
-- |
31.59 (14.17) |
-- |
−0.29 (2.35) |
(−4.93 to 4.34) |
0.90 |
C (n = 76) | -- | 32.80 (14.91) | -- |
Note: CI = confidence interval, ANCOVA = analysis of covariance with treatment, stratum, and pooled site effects and the corresponding baseline value as covariate used for the change from baseline (difference: endpoint-baseline) with p-values based on actual data.
*HbA1c – glycosylated hemoglobin.
†FPG – fasting plasma glucose.
‡OAD – oral anti-diabetes drug.
§OAD score = sum of all OADs prescribed; OAD ½ to maximum dose = 1 OAD.
¶These are between-group results where change from workshop to 15 months was compared between intervention and control groups using ANCOVA, treatment effect is adjusted for baseline effect and pooled site effect.
**Intensification of diabetes management – Increased dose of OAD or insulin, increased OAD score, or the addition of insulin; Intensification is a one-time post workshop variable, therefore no within group differences.