MARCIA A. TESTA, MAXWELL SU, ALEXANDER TURCHIN, DONALD C. SIMONSON, Boston, MA

Patient-Centered Outcomes and Socio-Demographic Predictors of Diabetes Treatment Effectiveness. Author(s):  MARCIA A. TESTA, MAXWELL SU, ALEXANDER TURCHIN, DONALD C. SIMONSON, Boston, MA

Achieving glycemic treatment targets varies depending on clinical characteristics; however, the role of socio-demographic and patient-centered outcomes on treatment effectiveness is not as well established. We analyzed treatment effectiveness heterogeneity in T1D and T2D using pooled data from 8 randomized trials (2,927 patients, 413 clinics, 18 arms) including 12 regimens of insulin and oral agents (metformin, sulfonylureas, thiazolidinediones) alone or in combination during 24 – 52 wks. Socio-demographics, patient-reported treatment satisfaction (71 items) and quality of life (QOL, 154 items) questionnaires were completed longitudinally. Effectiveness measures (A1c endpoint mean, and probability of endpoint A1c < 8% and < 7%) were modeled using linear and logistic regression. At baseline, subjects were 22.6% T1D (53% male, age 32 ± 14 yrs, A1c 8.0 ± 1.0%) and 77.4% T2D (58% male, age 56 ± 10 yrs, A1c 9.2 ± 1.2%, BMI 31 ± 5 kg/m²). Endpoint A1c was 7.7 ± 1.2% with interquartile range of 6.9 – 8.3%, (p = ns for T1D vs T2D). For T1D & T2D, 60.6% & 68.6% attained A1c < 8%, and 19.3% & 32.3% reached A1c < 7%. Regimen differences were found for all effectiveness measures (p < 0.001). Controlling for study, regimen, baseline A1c, age, BMI (all p< 0.001), and diabetes type, gender, education, income, marital status and race (all p = ns), satisfaction and QOL improvements were associated with lower endpoint A1c and higher probability of A1c < 8% and < 7% (both p < 0.01). Satisfaction associations with treatment effectiveness were due primarily to subscales of greater perceived effectiveness (p < 0.001) and lower side effects (p < 0.05). QOL associations were due to favorable changes in subscales of symptom interference, mental health, health perceptions, health ratings, side effects and symptom distress, cognitive performance, and functional health (all p < 0.02). These findings support monitoring satisfaction and QOL outcomes to achieve glycemic treatment targets and improve quality of diabetes care.

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