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Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: Results from the A1chieve observational study

Siddharth Shah, Alexey Zilov, Rachid Malek, Pradana Soewondo, Ole Bech and Leon Litwak

Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 364 - 370

Received 20 September 2011, Revised 10 October 2011, Accepted 13 October 2011, Published online Nov-2011


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2. Methods

2.1. Study design

This was a 24-week, international, prospective, non-interventional, observational study of people with T2DM who had begun using biphasic insulin aspart 30 (premix), insulin aspart, or insulin detemir with or without oral glucose-lowering drugs (OGLDs). The study was carried out in 28 countries across four continents (Asia, Africa, Latin America and Europe): Algeria, Argentina, Bahrain, Bangladesh, China, Egypt, India, Indonesia, Iran, Jordan, Kuwait, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Tunisia, Turkey, United Arab Emirates and Yemen. Participants were recruited between January 2009 and June 2010, with an average observation period of 6 months. The insulin therapies were prescribed by a physician in the course of normal clinical practice, were commercially available, and were funded according to local practice in normal routine care. Further study design details and biomedical findings are given elsewhere (Home et al., submitted to Diabetes Res. Clin. Pract., this issue).

Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [11] x EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199-208 at baseline and after 24 weeks of therapy with insulin analogues. This questionnaire is a descriptive system of HRQoL states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each of these states can take one of three responses recording different levels of severity: no problems (=1), some or moderate problems (=2) and extreme problems (=3). These scores are not cardinal. The questionnaire also includes a rating for an individual's current HRQoL state, measured by a standard vertical 20 cm visual analogue scale (VAS). This EQ-5D VAS score ranges from 0 (worst imaginable health) to 100 (best imaginable health). The five health-state dimensions can be converted to a single utility value using a EQ-5D value set, in this case the UK VAS set, and are anchored by ‘1.00’ representing full health and ‘0.00’ representing the state ‘dead’.

2.3. Statistical analysis

Analyses were performed for people who completed the EQ-5D questionnaire at both baseline and 24 weeks. Change from baseline in HRQoL with the EQ-5D VAS as a continuous variable was analysed with the Wilcoxon signed-rank test. The change in percentage of people experiencing no problem in any of the measures was analysed with a chi-square test.

Analyses were further performed for the following groups: insulin-naïve people (people not taking insulin therapy at the time of entering into the study) and previously insulin-experienced people (current insulin users); by insulin analogue regimen (biphasic insulin aspart 30, insulin detemir alone, insulin aspart alone, insulin aspart used with any basal insulin [analogue or otherwise]); by seven geographical regions (for details of these see primary report, Home et al., submitted to Diabetes Res. Clin. Pract., this issue).

References

Label Authors Title Source Year
[11]

References in context

  • Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [11] at baseline and after 24weeks of therapy with insulin analogues.
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EuroQol Group EuroQol—a new facility for the measurement of health-related quality of life Health Policy. 1990;16(3):199-208 1990

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