OBJECTIVE To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients' health-related quality of life (HRQoL), and physicians' satisfaction in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians' satisfaction. RESULTS At month 6, the mean change in HbA1c levels was -0.04 ± 0.5% (-0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05). CONCLUSIONS The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.

中文翻译：

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在西班牙安达卢西亚，评估远程医疗护理对多剂量胰岛素和次优HbA1c的1型糖尿病患者的影响的随机研究：PLATEDIAN研究。

目的为了评估使用糖尿病患者平台进行远程医疗访问与面对面访问相比对1型糖尿病患者的临床结局，患者健康相关的生活质量（HRQoL）和医师满意度的影响。研究设计和方法PLATEDIAN（关于1型糖尿病安达卢西亚患者代谢控制的远程医学）（NCT03332472）是一项针对1型糖尿病患者进行的多中心，随机，为期6个月，开放标签，平行分组的对照研究。代谢控制欠佳（HbA1c <8％[<64 mmol / mol]），每天多次注射治疗。共有388名患者进行了资格评估；其中379人被随机分为1：1到3次面对面就诊（对照队列[CC]）（n = 167），或使用糖尿病患者通过远程医疗就诊进行中间面对面就诊（干预队列[IC]）（n = 163） ）。主要功效终点是从基线到第6个月HbA1c水平的平均变化。其他功效和安全终点是平均血糖，葡萄糖变异性，低血糖和高血糖发作，患者报告的结果以及医生的满意度。结果在第6个月，CC中HbA1c水平的平均变化为-0.04±0.5％（-0.5±5.8 mmol / mol），而IC中为0.01±0.6％（0.1±6.0 mmol / mol）（P = 0.4941） 。CC和IC中HbA1c <7％（<53 mmol / mol）的患者分别为73和78。在6个月的安全终点上未发现显着差异。首次访视和最终访视之间的HRQoL变化在不同人群之间没有差异，并且由于担心发生低血糖（FH-15得分≥28），基线观察到的统计学显着性差异在6个月时未发生变化（P <0.05）。结论在HbA1c <8％（<64 mmol / mol）的1型糖尿病患者中使用远程医疗可提供与面对面就诊相似的疗效和安全性结果。