Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial

Kurnikowski, Amelie; Werzowa, Johannes M.; Hödlmoser, Sebastian; Krenn, Simon; Paschen, Christopher; Mussnig, Sebastian; Tura, Andrea; Harreiter, Jürgen; Krebs, Michael; Song, Peter X. K.; Eller, Kathrin; Pascual Santos, Julio; Budde, Klemens; Hecking, Manfred; Schwaiger, Elisabeth

doi:http://dx.doi.org/10.1016/j.xkme.2024.100860

Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial

Llicència

Citació

Kurnikowski A, Werzowa J, Hödlmoser S, Krenn S, Paschen C, Mussnig S, et al. Continuous insulin therapy to prevent post-transplant diabetes mellitus: A randomized controlled trial. Kidney Med. 2024 Jun 21;6(8):100860. DOI: 10.1016/j.xkme.2024.100860

Resum

Rationale & objectives: Hyperglycemia 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 design: Open-label randomized parallel 3-arm design. Settings & participants: In total, 85 kidney transplant recipients without previous diabetes diagnosis were randomized to postoperative CSII therapy, basal insulin, or control. Interventions: Insulin was to be initiated at afternoon capillary blood glucose level of ≥140 mg/dL (7.8 mmol/L; CSII and basal insulin) or fasting plasma glucose level of ≥200 mg/dL (11.1 mmol/L; control). Outcomes: Hemoglobin A1c (HbA1c) levels at 3 months post-transplant (primary endpoint). PTDM assessed using oral glucose tolerance test at 12 and 24 months. Results: CSII therapy lasted until median day 18 and maximum day 88. The median HbA1c value 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 with 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. Limitations: This study is limited by outdated insulin pump technology, frequent discontinuations of CSII, a complex protocol, and concerns regarding reliability of HbA1c measurements. Conclusions: CSII therapy was not superior at reducing HbA1c levels at month 3 or PTDM prevalence at months 12 and 24 compared with the control or basal insulin group.