The ambitious FPG target applied in this study was ∼1 mmol/L lower than that of most previous treat-to-target type 1 diabetes studies, and both insulin regimens lowered FPG substantially.
Endpoint FPG values were substantially above target levels for both treatment group; however, FPG values were within the range observed in previous treat-to-target studies (5.6 7.4 mmol/l) 3, 15, 30– 30.
The level of overall glycaemic control (HbA1c) obtained with IDeg and IDet in this trial was comparable to that achieved in previous treat-to-target trials with IDet at a similar treatment regimen 10, 14.
Although these values do not differ greatly from the 50 50 split generally recommended with basal-bolus therapy, previous treat-to-target studies in adult type 1 diabetes cohorts of similar BMI to ours have tended to report 50 60% of the total insulin dose constituting basal insulin (29, 37, 38).
It is reassuring to note that the absolute rates for overall and nocturnal hypoglycemia in our study were numerically similar (29) or reduced (37, 38) compared with previous treat-to-target studies in type 1 diabetes in which less ambitious glycemic targets have been used for both basal and bolus insulin titration.
Also in previous treated patients there is the possibility to shorten treatment duration.
One PDPN participant was previous treated with Qutenza but did not recall the treatment.
While in naïve G1 CHC patients, IL28B status and RVR achievement are able to identify patients where DT is not inferior to TT in terms of SVR, no DT easy-to-treat sub-groups of previous treated patients were identified.
We performed two sub-analyses that restricted the control groups to either CAT I, of which 28/142 (20%) were previous treated for TB or CAT II, of which 87/94 933%) were previously treated.
An infection episode was defined as a positive culture occurring at least 7 days after a previous treated culture or if the culture isolates were different from the previous culture [ 13].
However these results, not applicable to patients with severe fibrosis, were not considered by EMA that suggests a 48 weeks therapy also in previous treated patients with eRVR [ 17].
