RESUMEN
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 Limitations: This study is limited by outdated insulin pump technology, frequent discontinuations of CSII, a complex protocol, and concerns regarding reliability of HbA1c measurements.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.
RESUMEN
Objective. Bioimpedance spectroscopy (BIS) is a non-invasive diagnostic tool to derive fluid volume compartments from frequency dependent voltage drops in alternating currents by extrapolating to the extracellular resistance (R0) and intracellular resistance (Ri). Here we tested whether a novel BIS device with reusable and adhesive single-use electrodes produces results which are (in various body positions) equivalent to an established system employing only single-use adhesive electrodes.Approach. Two BIS devices ('Cella' and the 'Body Composition Monitor' [BCM]) were compared using four dedicated resistance testboxes and by measuring 40 healthy volunteers.Invivocomparisons included supine wrist-to-ankle (WA) reference measurements and wrist-to-wrist (WW) measurements with pre-gelled silver/silver-chloride (Ag/AgCl) electrodes and WW measurements with reusable gold-plated copper electrodes.Main results. Coefficient of variation were <1% for all testbox measurements with both BIS devices. Accuracy was within ±1% of true resistance variability, a threshold which was only exceeded by the Cella device for all resistances in a testbox designed with a lowR0/Riratio.Invivo, WA-BIS differed significantly between BIS devices (p< 0.001). Reusable WW electrodes exhibited larger resistances than WW-BIS with Ag/AgCl electrodes (R0: 738.36 and 628.69 Ω;Ri: 1508.18 and 1390 Ω) and the relative error varied from 7.6% to 31.1% (R0) and -15.6% to 37.3% (Ri).Significance. Both BIS devices produced equivalent resistances measurements but different estimates of body composition bothinsilicoand in WA setupsinvivo, suggesting that the devices should not be used interchangeably. Employing WW reusable electrodes as opposed to WA and WW measurement setups with pre-gelled Ag/AgCl electrodes seems to be associated with measurement variations that are too large for safe clinical use. We recommend further investigations of measurement errors originating from electrode material and current path.