Quality of life as a key indicator of patient satisfaction and treatment compliance in people with type 2 diabetes mellitus in the IMPROVE study: a multicentre, open label, non-randomised, observational trial.

Diabetes is a debilitating chronic illness having multiple impacts on physical and mental well-being of patients. When treating chronic conditions like diabetes, psychosocial aspects and quality of life (QoL) have to be considered; however, these receive less attention due to various reasons. Patients with diabetic complications have increased levels of depression and decreased QoL This necessitates evaluating QoL of patient which now is used as a primary or secondary end point in clinical trials eg, Diab-MedSat QoL questionnaire used in diabetes. At some point all diabetic patients may require insulin to control hyperglycaemia and disease progression. The traditional insulin syringe and needle delivery system has been the principal barrier in the treatment of diabetes as it was not well accepted among the patients due to various reasons. A success over this approach has been pen like devices like FlexPen and Novopen3 which are becoming more popular than the conventional syringe-and-needles as they have several advantages like, easy to carry, use, maintain and also reduces administrative errors ensuring accurate doses are delivered. The objective of IMPROVE study is to evaluate the safety and effectiveness of biphasic insulin aspart (NovoMix 30) in normal clinical practice conditions, in India. This is an open label, non-randomised, non-interventional, observational, safety and effectiveness study in approximately 17,995 patients with type 2 diabetes mellitus. A cohort of Indian patients (n = 349) from all 4 geographical locations (North, West, East and South of India) were administered QoL instrument Diab-MedSat at baseline and 346 patients at final visit (n = 346) to assess their satisfaction with the treatment they received. The results were included in the final statistical analysis as additional outcome variables. The Diab-MedSat Novo Nordisk June 2004 English (UK) version is used. The Diab-MedSat has 21 items that need to be answered and it is scored as an overall score (all 21 items) as well as three subscale scores regarding burden (11 items), symptoms (5 items), efficacy (5 items). The complete analysis took into account all 21 items of Diab-MedSat questionnaire with their subscales. Analyses of the cohort showed higher patient satisfaction among the patients administered Diab-MedSat questionnaire from baseline (n = 349) to final visit (n = 346). The mean of overall score was 52.33 (baseline visit) versus 79.03 (final visit). The difference in the overall score and sub parameters like burden, symptoms and efficacy between the baseline and final visits were statistically significant (p-value < 0.001). The mean value of difference in overall score between the baseline visit and final visit was 26.73 +/- 20.83; while the difference for burden, symptoms and efficacy were respectively 27.86 +/- 20.81, 19.75 +/- 20.94 and 32.87 +/- 28.08. A fairly clear picture emerged that the use of biphasic insulin aspart resulted in improved QoL of the patients substantially. This is demonstrated in the results for all the parameters that were used like symptoms, efficacy and burden. The overall number of extremely satisfied patients had increased from 5.4% in the baseline visit to 91% in the final visit. This unambiguously proves that the satisfaction of patients on biphasic insulin aspart (NovoMix 30) is beyond question.