Aims: In adults with long-standing type 1 diabetes and problematic hypoglycaemia, the 24-week HypoCOMPaSS randomised controlled trial investigated the impact of insulin pump vs multiple daily injections (MDI) and real-time continuous glucose monitoring (CGM) vs conventional self-monitoring (SMBG). It demonstrated improved awareness of hypoglycaemia and reduction in severe hypoglycaemia in all groups. Our aim was to investigate satisfaction with insulin delivery modality and perceived glucose monitoring experience between baseline and 24 weeks, and examine between-group differences in these outcomes at 24 weeks, by insulin administration and glucose monitoring device allocation.
Methods: Participants (N=96) were: 64% women, aged 49±12 years, diabetes duration 29±12 years. At baseline and 24 weeks, participants completed: Insulin Treatment Satisfaction Questionnaire (ITSQ) subscales: ‘hypoglycaemia control’ and ‘device delivery’ satisfaction; and ‘Glucose Monitoring Experience Questionnaire’ (GME-Q), providing three scores (‘convenience’, ‘effectiveness’, ‘intrusiveness’). Repeated measures t-tests examined change (0-24 weeks), and independent groups t-tests compared 24-week scores by insulin and monitoring allocation.
Results: Over 24 weeks, participants reported significant improvements (p<0.001) in perceived ‘effectiveness’ (Cohen’s d=0.66) and ‘intrusiveness’ (d=0.37) of their monitoring device, but no change in ‘convenience’ (p=0.139). Satisfaction with insulin ‘device delivery’ and ‘hypoglycaemia control’ improved (p<0.001, d=0.64 and 0.98 respectively). At 24 weeks, CGM users reported greater perceived ‘effectiveness’ than SMBG users (p=0.026, d=0.49), and pump users reported greater satisfaction with insulin ‘device delivery’ than MDI users (p<0.001, d=0.82).
Conclusions: Overall, significant improvements were observed over the 24 weeks, in all domains except ‘convenience’. While HypoCOMPaSS demonstrated non-inferiority of SMBG versus CGM, and MDI versus insulin pump in terms of biomedical outcomes, patient-reported outcome measures suggest higher satisfaction with pump use and greater perceived effectiveness with CGM use.