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Kurnikowski, A; Werzowa, J; Hodlmoser, S; Krenn, S; Paschen, C; Mussnig, S; Tura, A; Harreiter, J; Krebs, M; Song, PXK; Eller, K; Pascual, J; Budde, K; Hecking, M; Schwaiger, E.
Continuous Insulin Therapy to Prevent Post-Transplant Diabetes Mellitus: A Randomized Controlled Trial
KIDNEY MED. 2024; 6(8): 100860
Doi: 10.1016/j.xkme.2024.100860
[OPEN ACCESS]
Web of Science
PubMed
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FullText_MUG
- Co-Autor*innen der Med Uni Graz
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Eller Kathrin
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Schwaiger Elisabeth
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- Abstract:
- 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 LIMITATIONS: This study is limited by outdated insulin pump technology, frequent discontinuations of CSII, a complex protocol, and concerns regarding reliability of HbA1c measurements.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.