Effects of a telemedically supported home-based lifestyle intervention in patients with chronic ischaemic heart disease and type 2 diabetes mellitus

Abstract

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Federal Joint Committee Germany Background Ischaemic heart disease is the leading cause of global mortality and when accompanied by type 2 diabetes mellitus (T2DM), prognosis is even worse. Lifestyle (LS) interventions are recommended, however, evidence in patients with both chronic ischaemic heart disease (CIHD) and T2DM is scarce. Furthermore, LS interventions were generally performed in a resource intensive supervised setting. Therefore, this study examined whether an individualised telemedically supported home-based LS intervention has a different effect on changes in glycosylated haemoglobin (HbA1c) compared to usual care (UC) in patients with CIHD and T2DM. Methods Eligible patients (ICD-10: I20-25; HbA1c≥6.5% or anti-diabetic drugs) were randomly assigned (1:1) to LS or UC at 11 sites. LS intervention consisted of home-based exercise training (ET) and nutritional recommendations following 7-day nutrition diaries. ET was based on the results of a cardiopulmonary exercise test (CPET), i.e. ventilatory thresholds and peak oxygen consumption, and was provided and recorded by a smartphone application. Intensities varied and volume was gradually increased to reach at least 150 min/week. Every 2-4 weeks, patients were contacted by telephone to receive feedback and adjust the training (if necessary). CPETs and nutrition diaries were analysed by a core laboratory, which also provided the feedback to the patients. Primary endpoint was the change in HbA1c after 6 months. Secondary endpoints included change in weight, waist circumference, HDL, LDL, triglycerides and quality of life (QoL). The main analysis included all patients with baseline and follow-up (FU) measures (full analysis). In a per-protocol analysis (PPA), patients randomised to LS who performed less than 2/3 of the scheduled exercise time or filled less than 2 out of 3 nutrition diaries were excluded. Results Among 499 enrolled patients (mean age, 68 years; 16% female; mean HbA1c, 6.9%), 402 (81%) completed the 6-month FU. From 201 patients who completed FU in the LS group, 76 (38%) were included in the PPA [81 (40%) adhered to ET, 144 (72%) filled at least 2 nutrition diaries]. In the full analysis, mean change in HbA1c was significantly different between LS and UC (-0.1% [95% CI, -0.2 to 0.0], p=0.04). Furthermore, significant differences were found for changes in weight (p<0.001) and the QoL mental component score (MCS) of the Short-Form-36 questionnaire (p=0.006, Table 1). In the PPA, mean changes in HbA1c (p=0.002), weight (p<0.001), waist circumference (p<0.001), triglycerides (p=0.03) and the QoL MCS (p=0.004) were significantly different between groups (Table 1). Conclusion In patients with CIHD and T2DM, a telemedically supported home-based LS intervention significantly reduced HbA1c as compared to UC. However, only in the per-protocol analysis, change in HbA1c met a clinically meaningful difference of 0.3% between groups. Therefore, future studies should aim at increasing adherence to such interventions.