Dealing with ceiling baseline treatment satisfaction level in patients with diabetes under flexible, functional insulin treatment: Assessment of improvements in treatment satisfaction with a new insulin analogue

Even a small improvement in satisfaction with treatment for a chronic disea se can be valuable. However, sensitive measurements instruments are needed to assess the effects of treatment changes in patients already well satisfi ed with baseline treatment. Such instruments were thought to be necessary t o deal with ceiling effects in scores of satisfaction with functional insul in treatment (FIT) accommodating full flexibility of food intake and lifest yle in diabetes by manipulation of insulin (FIT; Howorka etal. 2000). The S tatus(S) version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ , Bradley 1994) was extended with items measuring specific components of FI T and its psychometric properties investigated in a validation study with 1 71 FIT patients with diabetes. A new Change(C) version of DTSQ extended for FIT was used together with the DTSQ(S) by 52 participants in a subsequent randomised cross-over study involving new fast-acting lispro vs. regular in sulin, where treatment satisfaction was the primary outcome variable. Insul in lispro use improved satisfaction (p less than or equal to 0.001) both, o n classical and extended versions of DTSQ(S) and (C), despite high baseline levels of satisfaction. However, the DTSQ(C) augmented the effects of lisp ro (p = 0.0001) apparent on DTSQ(S) scores and revealed significant treatme nt effects (p less than or equal to 0.01) not significant with DTSQ(S). In parallel, glycaemic control improved with lispro (e.g., HbA(1)c, p = 0.023) . Improved satisfaction with treatment was more apparent with DTSQ(C) than DTSQ(S) in patients who at baseline were at or near ceiling for treatment s atisfaction.