[Costs of therapy of insulin-treated patients with Diabetes mellitus in Germany. Results of the JEVIN trial].

BACKGROUND AND PURPOSE: Diabetes mellitus, its treatment with oral antidiabetic drugs and insulin, self-monitoring and the development of diabetesrelated long-term complications raise multiple socioeconomic problems. Hence, diabetes is one of the major challenges to modern health care systems. To date, there are only few data analyzing diabetes-related costs. Therefore, it was the aim of this trial to assess the costs of therapy of insulin-treated patients with diabetes mellitus out of a selection-free population over a period of 5 years.

PATIENTS AND METHODS: JEVIN (Jena's St. Vincent trial) is a prospective population-based trial of all patients with type 1 and insulin-treated type 2 diabetes mellitus aged 16-60 years and living in the city of Jena, Thuringia, Germany. In addition to parameters of diabetes control (relative hemoglobin A(1c) [= HbA(1c)/mean normal], long-term complications, blood pressure), the costs of therapy in respect of insulin and oral antidiabetic drugs and materials to perform self-monitoring were analyzed in 1999/2000 compared to 1994/95. In 1994/95, 244 patients, in 1999/2000, 291 patients were examined.

RESULTS: During the period from 1994/95 to 1999/2000, relative HbA(1c) improved in both patients with type 1 (1.65 +/- 0.35 [n = 127] vs 1.48 +/- 0.30 [n = 114]; p < 0.0001) and insulin-treated type 2 diabetes (1.75 +/- 0.40 [n = 117] vs. 1.47 +/- 0.25 [n = 147]; p < 0.0001). The quality of blood pressure control remained constant. In 1999/2000 the costs per unit insulin for patients with type 1 diabetes were calculated at about 0.078 +/- 0.035 DM, in 1994/95 at 0.075 +/- 0.032 DM (p = 0.873). For patients with type 2 diabetes the costs were calculated at 0.070 +/- 0.032 DM in 1999/2000 and at 0.070 +/- 0.028 DM (p = 0.954) in 1994/95. In 1999/2000, to perform blood glucose self-monitoring the costs were 4.08 +/- 1.39 DM/d for patients with type 1 diabetes and 3.07 +/- 1.36 DM/d for patients with type 2 diabetes. In 1994/95 the costs for patients with type 1 diabetes amounted to 3.56 +/- 1.69 DM/d (p = 0.012), and for patients with insulin-treated type 2 diabetes mellitus to 2.77 +/- 1.66 DM/d (p = 0.138). In 1999/2000 the costs for antihypertensive drugs in 46/114 patients with type 1 diabetes were calculated at about 1.43 +/- 1.10 DM/d. In 1994/95 the costs for 32/127 patients amounted to 1.76 +/- 1.00 DM/d (p = 0.501). For 104/147 patients with insulin-treated type 2 diabetes, the costs of antihypertensive drugs were 2.02 +/- 1.48 DM/d in 1999/2000. In 1994/95 the costs amounted to 1.77 +/- 1.11 DM/d (p = 0.141) for 54/117 patients. In 1994/95 the total costs for patients with type 1 diabetes mellitus were calculated at about 7.10 +/- 2.69 DM/d. In 1999/2000 the costs amounted to 7.70 +/- 2.75 DM/d (p = 0.085). In patients with insulin-treated type 2 diabetes mellitus there was a significant increase in 1999/2000 versus 1994/95 (1994/95: 6.43 +/- 3.16, 1999/2000: 7.57 +/- 3.56 DM/d; p = 0.007).

CONCLUSION: Despite a tendency toward an increase in the costs for daily life, the therapy-related costs for patients with type 1 diabetes mellitus were constant in 1999/2000 versus 1994/95. In patients with type 2 diabetes, there was an increase of about 18%. For both patients with type 1 and type 2 diabetes, the costs were substantially higher than calculated in theoretical models.