A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes

Abstract

Background: This study evaluated whether a home telehealth (HT) system enabling the patient to monitor body weight, blood glucose values, and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus, compared with usual practice.

Materials and methods: This was a randomized, parallel-group (1:1), open-label, multicenter study conducted in general practice. Follow-up was for 12 months.

Results: Overall, 29 general practitioners enrolled 302 patients (153 assigned to the HT group and 149 to the control group). Use of the HT system was associated with a statistically significant reduction in glycated hemoglobin (HbA1c) levels compared with the control group (estimated mean difference, 0.33±0.1; P=0.001). No difference emerged as for body weight, blood pressure, and lipid profile. The proportion of patients reaching the target of HbA1c <7.0% was higher in the HT group than in the control group after 6 months (33.0% vs. 18.7%; P=0.009) and 12 months (28.1% vs. 18.5%; P=0.07). As for quality of life (evaluated with the 36-item Short Form health survey), significant differences in favor of the HT group were detected as for physical functioning (P=0.01), role limitations due to emotional problems (P=0.02), mental health (P=0.005), and mental component summary (P=0.03) scores. A lower number of specialist visits was reported in the telemedicine group (incidence rate ratio, 0.72; 95% confidence interval, 0.51-1.01; P=0.06).

Conclusions: Use of the HT system was associated with better metabolic control and quality of life; a marginally nonsignificant lower resource utilization was also documented. No impact was documented on blood pressure, lipid profile, and body weight.

Trial registration: ClinicalTrials.gov NCT02194608.