Abstract
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.
Highlights
Posttransplantation diabetes mellitus (PTDM) is a serious and common complication after solid organ transplantation affecting a substantial proportion of kidney transplant recipients
Designing a continuous subcutaneous insulin lispro infusion (CSII) algorithm based on the glucose data from our previous TIP-study, we hypothesized that administration of the maximal insulin dose during the afternoon would improve daily glucose profiles compared to basal insulin isophane and standard-of-care in kidney transplant recipients without a previous history of DM
Twenty-eight fully consented individuals were randomized into the CSII group immediately before kidney transplantation
Summary
Posttransplantation diabetes mellitus (PTDM) is a serious and common complication after solid organ transplantation affecting a substantial proportion of kidney transplant recipients. Almost all patients experience hyperglycemic episodes immediately after kidney transplantation [2], mainly as a consequence of high steroid and calcineurin inhibitor doses, and due to several other reasons [3] This vulnerable early phase may play a pivotal role in the later development of PTDM [4]. The results of the TIP study prompted a large multi-center clinical trial aimed at testing the hypothesis that early basal insulin treatment after kidney transplantation may prevent later PTDM development (ITP-NODAT trial, ClinicalTrials.gov Identifier NCT01683331). This trial is currently enrolling patients with an intended sample-size of 300 patients in the US and Europe (NPH insulin versus conventional therapy). Designing a CSII algorithm based on the glucose data from our previous TIP-study, we hypothesized that administration of the maximal insulin dose during the afternoon would improve daily glucose profiles compared to basal insulin isophane and standard-of-care in kidney transplant recipients without a previous history of DM
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