Hospital stays and costs of telemedical monitoring versus standard follow-up for diabetic foot ulcer: an open-label randomised controlled study

Abstract

Background: Two randomised controlled trials (RCTs) have previously shown that telemedical monitoring of diabetic foot ulcer (DFU) reduces the number of visits to the outpatient clinic, without losing treatment efficacy or increasing costs. Here we present the results of an open-label, randomised controlled trial designed to investigate whether telemonitoring, provided by an expert nurse (with extensive experience in DFU and trained in remote monitoring), reduces the hospital stay and the associated costs for a patient with DFU (TELEPIED trial).

Methods: Eligible patients (n = 180) were randomly allocated to: (i) a control group, in which they received standard care, and (ii) an intervention group, in which they received asynchronous telemedicine follow-up by the expert nurse. The primary outcome was the cumulative hospital days over 12 months. The main secondary outcomes were (i) direct healthcare costs (estimated in a collective perspective), (ii) wound healing and (iii) amputation rates. ITT (intention-to-treat) population was analysed.

Findings: In the ITT population, cumulative hospital days were significantly higher in the control group (13.4 days [95% CI 9.0-17.8]) than in the intervention group (7.1 days [2.8-11.5]) (p = 0.0458, ANCOVA model). Cumulative direct costs over 12 months were 7185 € (95% CI 5144-9226) in the control group and 3471 € (95% CI 1430-5512) in the intervention group (p = 0.0120). The percentage of wounds healed and amputation rate were not significantly different between groups. Similar results were found with the PP population.

Interpretation: The implementation of a telemedical intervention with an expert nurse could lead to a length of hospitalization and direct costs that were two times lower compared to conventional follow-up. This lower medical and economic burden was obtained without losing effectiveness on the rate of healing, nor increasing the amputation rate. Additional studies are required to confirm these findings.

Funding: This study was designed, funded and conducted by CERITD (Study and Research Centre for Intensification of Diabetes Treatment, Evry, France), Genopole GIP, 20 rue Henri Desbruères, 91030 EVRY Cedex and Laboratoires URGO, 15 Avenue d'Iéna, 75116 Paris Cedex, France. The findings and conclusions in this study are those of the authors and do not necessarily represent the views of the sponsor. The corresponding author (DD) certify that authors were not precluded from accessing data in the study, and they accept responsibility to submit for publication.

Keywords: Clinical trial; Diabetes; Diabetes complications; Diabetic foot ulcer; Expert nurse; Health cost; Hospitalization; Telehealth; Telemedicine.

Fig. 1

Study protocol. Eligible patients were randomly allocated to: (i) a control group, where they received standard follow-up (mixed hospital/ambulatory), and (ii) an intervention group, where they received telemedicine follow-up by an expert nurse. The expert nurse established a personalized telemedicine plan for each patient (intermediate visit, V1bis), based on the availability of the community nurse (who provided home care). The participants were followed up for 12 months.

Fig. 2

Consort flowchart of the study showing the number of individuals in the intention-to-treat (ITT) analysis (allocation panels) and in the per-protocol analysis (analysis panels). A total of 180 patients were included in the study and randomly allocated to experimental groups. ITT analysis was performed on 90 participants assigned to standard, hospital follow-up (control group) and another 90 assigned to telemedical, outpatient follow-up (intervention group). Per-protocol analysis (PP) was performed on 72 participants assigned to the control group and another 67 assigned to the intervention group.