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Greater fear of hypoglycaemia with premixed insulin than with basal‐bolus insulin glargine and glulisine: patient‐reported outcomes from a 60‐week randomised study
Author(s) -
Polonsky W. H.,
Thompson S.,
Wei W.,
Riddle M. C.,
Chaudhari S.,
Jackson J.,
Bruno A. S.
Publication year - 2014
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12328
Subject(s) - insulin glargine , medicine , continuous glucose monitoring , basal insulin , insulin , basal (medicine) , bolus (digestion) , hypoglycemia , anesthesia , diabetes mellitus , type 2 diabetes , endocrinology , glycemic
Aim To assess the effect of initiating insulin treatment on quality of life of patients with type 2 diabetes ( T2DM ) in the 60‐week All‐to‐Target trial ( NCT00384085 ). Methods Patient‐reported outcomes from a phase IV , multicentre, randomised, open‐label, parallel‐group study were analysed. Participants were randomised to: insulin glargine with up to one insulin glulisine injection (G + 1); insulin glargine with stepwise addition of up to three insulin glulisine injections (G + 3); or twice‐daily premixed 70/30 insulin protamine‐aspart/aspart ( PM ‐2). Patient‐reported outcome questionnaires were administered at weeks 0, 6, 12, 24, 36, 48 and 60. Results There were no between‐group differences in the Psychosocial Adjustment to Illness State–Self Report ( PAIS‐SR ) or in the EuroQoL Group Five‐Dimension Self‐Report Index Questionnaire ( EQ‐5D ) from baseline to week 60; however, PAIS–SR scores improved significantly over this period in the G + 3 group (p = 0.0016) and EQ‐5D scores worsened significantly in the PM ‐2 group (p = 0.02). Hypoglycemia Fear Survey Behaviour and Worry subscales worsened significantly for all groups, with greater deterioration being observed in the PM ‐2 group than in the G + 1 group (Behaviour, p = 0.0050; Worry, p = 0.0017) and G + 3 groups (Behaviour, p = 0.0105; Worry, p = 0.0016). Total scores on the Diabetes Quality of Life ( DQoL ) questionnaire improved more in the G + 3 group than in the PM ‐2 group over the study period (p = 0.0284), with all groups showing a significant improvement in DQoL score over time. Conclusion Insulin glargine‐based regimens showed advantages over premixed insulin in a number of patient‐reported outcome measures. The potential impact on fear of hypoglycaemia may be of particular relevance when addressing the major barriers to early insulin treatment.