CGMS
A total of 39 volunteers (26 male and 13 female) were recruited to the CGMS sub-study. Baseline characteristics for all participants who completed both baseline and 12
month CGMS measurements were similar and not significantly different from the main group of volunteers. Results are reported for the 29 volunteers who completed all
measurements.
The 24 h average blood glucose decreased significantly with time (p Z 0.001) by 1.6 0.5 and 0.7 0.4 mmol/L in HPD and SPD respectively at 4 months. Between 4 and 12
months the 24 h BG increased and was not different from baseline in either group. Adjusting for baseline values revealed a treatment effect at 4 months (p Z 0.023) but
not at 12 months (p Z 0.12).
%T > 10 decreased significantly between baseline and 4 months (p Z 0.003). The HPD group decreased from 22% to 6% (relative change 73%) and the SPD group decreased
from 19% to 10% (relative change 47%) with no significant treatment effect. At the end of the study %T > 10 was notsignificantly different from baseline (HPD 16% and SPD
20%).
At 4 months Gmax had decreased by 2.2 1.1 HPD and 1.1 1.0 mmol/L SPD (p Z NS adjusted for baseline). Gmax increased between 4 and 12 months and did not differ significantly from baseline. AUC decreased in HPD by 2155 and in SPD by 1004 (mmol/L/min) p Z 0.001 for time. AUC increased in both groups between 4 and 12 months and was no longer significantly different from baseline. Adjusting for baseline values there was no significant effect of treatment at 12 months.
The change in AER was significantly correlated with the change in Gmax at 12 months (r Z 0.389; p Z 0.037) but after adjusting for baseline AER and weight loss (r2Z0.57;
p Z0.028); change in Gmax was not significant (pZ0.14). All CGMS variables were strongly correlated with HbA1c at both 4 and 12 months (Gmax r Z 0.574, p Z 0.001; %
T > 10 r Z 0.695, p < 0.00; AUC r Z 0.692, p < 0.00; mean 24 h BG r Z 0.651, p < 0.00 at 12 months). SBP was significantly correlated with 24 h BG (r Z 0.38; p Z 0.04)
at 4 months but not at 12 months.