Greater fear of hypoglycaemia with premixed insulin than with basal‐bolus insulin glargine and glulisine: patient‐reported outcomes from a 60‐week randomised study. Issue 11 (12th July 2014)

• Record Type: Journal Article
• Authors: Polonsky, W. H.; Thompson, S.; Wei, W.; Riddle, M. C.; Chaudhari, S.; Jackson, J.; Bruno, A. S.
• Is Part Of: Diabetes, obesity & metabolism. Volume 16:Issue 11(2014:Nov.)
• Page Start: 1121
• Page End: 1127
• Publication Date: 2014-07-12
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12328
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12328-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12328-sec-0001" sec-type="section"> <title>Aim</title> <p id="dom12328-para-0001">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).</p> </sec> <sec id="dom12328-sec-0002" sec-type="section"> <title>Methods</title> <p id="dom12328-para-0002">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.</p> </sec> <sec id="dom12328-sec-0003" sec-type="section"> <title>Results</title> <p id="dom12328-para-0003">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.</p> </sec> <sec id="dom12328-sec-0004" sec-type="section"> <title>Conclusion</title> <p id="dom12328-para-0004">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.</p> </sec> </abstract>