Health-related quality of life in the VA Feasibility Study on glycemic control and complications in Type 2 diabetes mellitus

Objective: The Veterans Affairs Cooperative Study in Diabetes Mellitus Type 2 Feasibility Trial (VA CSDM) studied standard and intensive glycemic treatment groups, achieving and maintaining for 27 months a difference in HbA1c of 2.1% (9.2% vs. 7.1%, respectively). A substudy planned in advance examined health status as assessed by a health status questionnaire obtained at baseline and 24 months. Design and methods: A randomized, prospective trial was carried out at five VA Medical Centers from 1990 to 1993. The sample involved 153 male veterans 40-69 years of age and with diabetes duration of 8 +/- 4 years, who were suboptimally controlled with standard glucose lowering treatment. The participants were randomized to intensive and standard treatment groups. In addition to a variety of indicators of glycemic control and complications, health-related qualify of life data were assessed using a 20-question version of the Medical Outcome Study instrument. Scores were evaluated at baseline and 24 months for changes between the treatment groups. Results: The two groups were similar at baseline with respect to age, duration of diabetes, complications, comorbidities, and reported physical activity. The intensive treatment group had more frequent, mandatory self-glucose monitoring (vs. occasional measurement in the standard) and received two or more daily insulin injections (only one in the standard). This group had three times the number of clinic visits and 10-fold higher reported incidence of mild/moderate hypoglycemia. There were no significant changes in the health status over time in either the standard or intensive treatment groups, nor was there a difference between the two groups. Conclusions: Intensive glucose control in advanced Type 2 diabetes mellitus (DM) has no effect on health status over 2 years. The successful lowering of glycemia does not improve health-related quality of life nor do the increased demands of an intensive therapy regimen worsen it. Published by Elsevier Inc.