The primary objective was to compare treatment
groups with regard to the time to treatment
failure, defined as a persistently elevated glycated
hemoglobin level (≥8%) over a period of 6 months
or persistent metabolic decompensation (defined
as either the inability to wean the participant from
insulin within 3 months after its initiation for decompensation
or the occurrence of a second episode
returned full, partially full, or empty at each visit,
with a target of at least 80% adherence
of decompensation within 3 months after
discontinuation of insulin). Glycated hemoglobin
testing was performed every 2 months in the first
year and quarterly thereafter. Diabetes care was
provided according to uniform study procedures7
(see Section B in the Supplementary Appendix).
Adherence was determined on the basis of counts
of pills in blister packs that were dispensed and