Table 3.
Three-Year-Old Neurodevelopmental Outcomes According to Treatment Group
| Outcome | Tight glycemic control (n = 124) |
Standard care (n = 145) |
pa |
|---|---|---|---|
| Bayley-III scoresb | (n = 96) | (n = 118) | |
| Age at testing, mean ± SD, mo | 37.0 ± 2.7 | 37.1 ± 2.6 | 0.93 |
| Composite scores, mean ± SD | |||
| Cognitive | 94.6 ± 14.7 | 95.7 ± 13.2 | 0.66 |
| Language | 97.8 ± 19.9 | 99.8 ± 17.2 | 0.44 |
| Motor | 89.3 ± 17.4 | 92.6 ± 16.9 | 0.19 |
| Subscale scores, mean ± SD | |||
| Cognitive | 8.9 ± 2.9 | 9.1 ± 2.6 | 0.66 |
| Receptive communication | 9.9 ± 3.4 | 10.2 ± 2.8 | 0.52 |
| Expressive communication | 9.2 ± 3.6 | 9.6 ± 3.3 | 0.36 |
| Fine motor | 8.9 ± 3.0 | 9.4 ± 3.0 | 0.27 |
| Gross motor | 7.5 ± 3.1 | 8.1 ± 3.0 | 0.16 |
| ABAS-II composite scores,mean ± SDc | (n = 84) | (n = 100) | |
| General Adaptive Composite | 89.2 ± 21.6 | 91.7 ± 19.4 | 0.42 |
| Conceptual | 95.0 ± 21.2 | 96.5 ± 19.5 | 0.64 |
| Social | 91.6 ± 20.4 | 95.5 ± 17.3 | 0.17 |
| Practical | 85.1 ± 19.8 | 87.3 ± 17.0 | 0.42 |
| BASC-2 composite T-scores,mean ± SDd | (n = 93) | (n = 116) | |
| Externalizing | 45.7 ± 9.7 | 46.8 ± 9.3 | 0.40 |
| Internalizing | 47.5 ± 10.2 | 47.6 ± 9.3 | 0.99 |
| Behavioral symptoms | 46.6 ± 9.4 | 46.7 ± 8.6 | 0.98 |
| Adaptive skills | 48.9 ± 9.7 | 50.4 ± 9.5 | 0.27 |
| ASQ-3, at risk,n (%)e | (n = 112) | (n = 131) | |
| Communication | 25 (22) | 24 (18) | 0.52 |
| Gross motor | 30 (27) | 30 (23) | 0.55 |
| Fine motor | 23 (21) | 16 (12) | 0.11 |
| Problem solving | 28 (25) | 24 (18) | 0.27 |
| Personal-social | 30 (27) | 23 (18) | 0.09 |
ABAS-II Adaptive behavior assessment system, second edition, ASQ-3 Ages and stages questionnaire, third edition, BASC-2 Behavior assessment system for children, second edition, Bayley-III Bayley scales of infant and toddler development, third edition
ap values for the comparison between treatment groups were calculated with the use of linear regression or stratified exact tests with adjustment for site, as appropriate
b Bayley-III cognitive and language composite scores and cognitive and receptive language subscale scores were not available for 1 tight glycemic control patient. Bayley-III motor composite score and gross motor subscale score were not available for 1 tight glycemic control patient
c ABAS-II general adaptive composite and social scores were not available for 1 tight glycemic control patient. ABAS-II general adaptive composite and practical scores were not available for 1 standard care patient
d BASC-2 internalizing composite T-score was not available for 2 tight glycemic control patients. BASC-2 internalizing and adaptive skills composite T-scores were not available for 1 standard care patient
e ASQ gross motor score was not available for 1 tight glycemic control patient