Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with Type 1 diabetes.
OBJECTIVE
To assess satisfaction with treatment and psychological well-being associated with insulin glargine and Neutral Protamine Hagedorn (NPH). Insulin glargine, a new long-acting insulin analogue, provides constant, peakless insulin release following once-daily administration and is associated with fewer hypoglycaemic episodes, despite metabolic control equivalent to that achieved with NPH human basal insulin.


METHODS
The Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Well-being Questionnaire (W-BQ) were completed at baseline and at weeks 8, 20 or 28 by 517 patients with Type 1 diabetes participating in a randomized, controlled European trial comparing insulin glargine and NPH. Analysis of covariance was performed on change from baseline scores (main effects: treatment and pooled site; covariate: baseline scores).


RESULTS
Treatment satisfaction improved with insulin glargine at all time points, including endpoint, but deteriorated slightly with NPH. These differences were significant throughout the study (change from baseline to endpoint: +1.27 vs. -0.56; P = 0.0001). Outcomes were better with insulin glargine for the DTSQ items, Perceived Frequency of Hyperglycaemia and Hypoglycaemia, with statistically significant differences at week 28 and endpoint for hyperglycaemia (P = 0.0373 and 0.0379) and at week 20 for hypoglycaemia (P = 0.0024). There was no difference in psychological well-being between the treatment groups, with mean scores increasing in both.


CONCLUSIONS
Study participants had treatment-independent improvements in General Well-being. Advantages for insulin glargine were seen in significantly improved Treatment Satisfaction throughout the study, together with lower Perceived Frequency of Hyperglycaemia than for patients on NPH, without a significant increase in Perceived Frequency of Hypoglycaemia.
Witthaus
E
E
Health Economics Research Group, Aventis Pharma Deutschland, Frankfurt, Germany. elke.witthaus@aventis.com
Stewart
J
J
Bradley
C
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D001294:Attitude to Health; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000069036:Insulin Glargine; D007336:Insulin, Isophane / Q000627:therapeutic use*; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D007328:Insulin; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; D007336:Insulin, Isophane