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

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.

Post-Transplant Diabetes Mellitus and Prediabetes in Renal Transplant Recipients: An Update

“…In the early period after transplantation, insulin is the preferable choice of treatment, with life-style modification and oral anti-diabetic therapy being the next step in the consensus treatment algorithm [97]. Previous studies demonstrated that aggressive anti-hyperglycaemic therapy with insulin, early (<3 weeks) after kidney transplant, lowered the risk for developing PTDM after 1 year [98] and the results of a following study, ITP-NODAT, using insulin pump technology to treat NO-DAT, is expected [99]. Both recent and ongoing trials on PTDM are depicted in Table 2.…”

Nutrition Trends in Kidney Transplant Recipients: the Importance of Dietary Monitoring and Need for Evidence-Based Recommendations

“…Despite increased awareness of NODAT and complications early post-transplant, there is no consensus on treatment or therapies ( 29 ). Carbohydrates (CHO) contribute the highest amount of energy in the typical American diet, making up 50% of total kilocalories from a recent report from 2007 to 2012 NHANES data ( 12 ).…”

Management of metabolic alterations in adult kidney transplant recipients: A joint position statement of the Italian Society of Nephrology (SIN), the Italian Society for Organ Transplantation (SITO) and the Italian Diabetes Society (SID)

“…In non-diabetic KTRs participating in a randomized controlled trial assessing the effectiveness and safety of continuous subcutaneous insulin lispro infusion (CSII, presupper BG target 110 mg/dL) as compared to basal insulin treatment (pre-supper BG target 110 mg/dL) and standard therapy (i.e. short-acting insulin lispro aiming at pre-lunch and pre-supper blood glucose values < 200 mg/dL), CSII resulted in significantly lower blood glucose levels during the first week after kidney transplantation, as compared to a basal insulin isophane regimen and to standard therapy for most time points [68]. However, longer term results of this study have not been published yet.…”