Effectiveness of the Telemedical Lifestyle Intervention Program TeLIPro for Improvement of HbA(1c) in Type 2 Diabetes: A Randomized-Controlled Trial in a Real-Life Setting

远程医疗生活方式干预项目 TeLIPro 对改善 2 型糖尿病患者糖化血红蛋白 (HbA1c) 水平的有效性:一项真实世界环境下的随机对照试验

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Abstract

The effectiveness of the multimodal Telemedical Lifestyle Intervention Program (TeLIPro) was proven in the advanced stages of type 2 diabetes mellitus (T2DM). Since its therapeutic potential focusing on telemedical coaching without using a formula diet is unknown, we evaluated improvements in HbA(1c), HbA(1c) normalisation rate, cardiometabolic risk factors, quality-of-life, and eating behaviour in real life. In this randomized-controlled trial, AOK Rhineland/Hamburg insured T2DM patients (n = 1163) were randomized (1:1) into two parallel groups, and 817 received the allocated intervention. In addition to routine care, all participants got scales, step counters, and access to an online portal. The TeLIPro group additionally received equipment for self-monitoring of blood glucose and telemedical coaching. Data were collected at baseline, after 6 and 12 months of intervention as well as after a 6-month follow-up. The primary endpoint after 12 months was (i) the estimated treatment difference (ETD) in HbA(1c) change and (ii) the HbA(1c) normalisation rate in those with diabetes duration < 5 years. The TeLIPro group demonstrated significantly stronger improvements in HbA(1c) (ETD -0.4% (-0.5; -0.2); p < 0.001), body weight, body-mass-index, quality-of-life, and eating behaviour, especially in T2DM patients with diabetes duration ≥ 5 years (ETD -0.5% (-0.7; -0.3); p < 0.001). The HbA(1c) normalisation rate did not significantly differ between groups (25% vs. 18%). Continuous addition of TeLIPro to routine care is effective in improving HbA(1c) and health-related lifestyle in T2DM patients with longer diabetes duration in real life.

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