A randomized controlled trial-based algorithm for insulin-pump therapy in hyperglycemic patients early after kidney transplantation

摘要

Treating hyperglycemia in previously non-diabetic individuals with exogenous insulin immediately after kidney transplantation reduced the odds of developing Posttransplantation Diabetes Mellitus (PTDM) in our previous proof-of-concept clinical trial. We hypothesized that insulin-pump therapy with maximal insulin dosage during the afternoon would improve glycemic control compared to basal insulin and standard-of-care. In a multi-center, randomized, controlled trial testing insulin isophane for PTDM prevention, we added a third study arm applying continuous subcutaneous insulin lispro infusion (CSII) treatment. CSII was initiated in 24 patients aged 55 +/- 12 years, without diabetes history, receiving tacrolimus. The mean daily insulin lispro dose was 9.2 +/- 5.2 IU. 2.3 +/- 1.1 % of the total insulin dose were administered between 00: 00 and 6: 00, 19.5+11.6% between 6: 00 and 12: 00, 62.3 +/- 15.6% between 12: 00 and 18: 00 and 15.9 +/- 9.1% between 18: 00 and 24: 00. Additional bolus injections were necessary in five patients. Mild hypoglycemia (52-60 mg/dL) occurred in two patients. During the first post-operative week glucose control in CSII patients was overall superior compared to standard-of-care as well as once-daily insulin isophane for fasting and post-supper glucose. We present an algorithm for CSII treatment in kidney transplant recipients, demonstrating similar safety and superior short-term efficacy compared to standard-of-care and once- daily insulin isophane.