Continuous Insulin Therapy to Prevent Post-Transplant Diabetes Mellitus: A Randomized Controlled Trial

Abstract

Rationale & ObjectivesHyperglycemia is frequently observed early after transplantation and associated with development of post-transplant diabetes mellitus (PTDM). Here, we assessed continuous subcutaneous insulin infusion (CSII) targeting afternoon hyperglycemia. Study DesignOpen label randomized parallel three-arm design. Settings & ParticipantsN=85 kidney transplant recipients (KTRs) without previous diabetes diagnosis were randomized to postoperative CSII therapy, basal insulin or control. InterventionsInsulin was to be initiated at afternoon capillary blood glucose ≥140 mg/dL (7.8 mmol/L; CSII and basal insulin) or fasting plasma glucose ≥200 mg/dL (11.1 mmol/L; control). OutcomesHbA1c at 3 months post transplant (primary endpoint). PTDM assessed by OGTT at 12 and 24 months. ResultsCSII therapy lasted until median day 18 and maximum day 88. Median HbA1c at month 3 was 5.6% (38 mmol/mol) in the CSII group versus 5.7% (39 mmol/mol) in the control group (p=0.70) and 5.4% (36 mmol/mol) in the basal insulin group (p=0.02). At months 12 and 24, the odds for PTDM were similar compared to the control group (odds ratios [95% confidence intervals], 0.80 [0.18-3.49] and 0.71 [0.15-3.16], respectively) and the basal insulin group 0.96 [0.18-5.68] and 1.51 [0.24-12.84], respectively). Mild hypoglycemia events occurred in the CSII and the basal insulin groups. LimitationsThis study is limited by outdated insulin pump technology, frequent discontinuations of CSII, a complex protocol and concerns regarding reliability of HbA1c measurements. ConclusionsCSII therapy was not superior at reducing HbA1c at month 3 or PTDM prevalence at months 12 and 24 compared to the control or basal insulin group.