Transplant Trial Watch

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

PLoS ONE [Electronic Resource] 2018; 13(3): e0193569.

Werzowa JM, Saemann MD, et al.

To determine the effectiveness of continuous subcutaneous insulin lispro infusion (CSII) for the prevention of Posttransplantation Diabetes Mellitus (PTDM) in kidney transplant recipients, compared to basal insulin therapy and standard-of-care.

Participants were invited to participate in the ITP-NODAT or SAPT-NODAT trials which looked at early basal insulin treatment and CSII treatment in preventing PTDM. Participants were randomised to one of three treatment arms, and received either basal insulin, CSII, or standard-of-care control.

85 kidney transplant recipients aged >18 years with no history of diabetes mellitus before transplantation, treated with a standard immunosuppressive regimen consisting of once-daily tacrolimus, mycophenolate, and steroids.

The primary outcome measured will be HbA1c three months after transplantation, to be published later. Current measured outcomes included the glycemic control and safety reguarding hypoglycemic events during the post-operative period.

24 months

CET Conclusions
This paper presents an algorithm for continuous subcutaneous insulin infusion (CSII) in renal transplant patients with hyperglycaemia. It does not present the full results of the related study for which it is an extension. Patients were randomised to basal insulin or to CSII. The study was not blinded and this paper does not describe the method of randomisation used, although it can be found in the online protocol. This paper concentrates on the glycaemic control and safety (hypoglycaemic events) in the three study arms of the ITP-NODAT and SAPT-NODAT trials during the first week post-operatively. Blood glucose levels were significantly lower with CSII than both basal insulin and control for fasting and post-supper levels. Blood glucose levels were significantly lower pre-supper with CSII compared to control but not basal insulin. There were no significant differences pre-lunch. Two patients on CSII each experienced one episode of hypoglycaemia, one symptomatic and one asymptomatic. Three patients requested that the CSII device be removed. Whether CSII can prevent the development of NODAT awaits completion of the SAPT-NODAT follow-up.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT01683331 and NCT01680185

Funding source
Non-industry funded