Effectiveness of a Lifestyle Improvement Support App in Combination with a Wearable Device in Japanese People with Type 2 Diabetes Mellitus: STEP-DM Study.

IF 3.8 3区医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-30 DOI:10.1007/s13300-024-01552-3

Akiko Takahashi, Manabu Ishii, Yurika Kino, Kazuyo Sasaki, Takahiro Matsui, Kenji Arakawa, Makoto Kunisaki

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Abstract

Introduction: Although the use of application (app)s and wearable devices supporting diabetes treatment has spread rapidly in recent years, evidence of their impact, especially in combination of them, is limited. TOMOCO™ is a lifestyle improvement support app that features interactive virtual conversations according to the programmed algorithm guiding users toward their goals of lifestyle improvement. We hypothesized that TOMOCO™ in combination with Fitbit, which accurately tracks users' activity level, would encourage people with type 2 diabetes mellitus (T2DM) to change their lifestyles and improve their glycated hemoglobin (HbA1c) levels without changes in conventional therapy. Thus, we performed the present study to explore the effectiveness of this combination in Japanese participants with T2DM who had not achieved their glycemic targets.

Methods: In this single-arm exploratory study, participants with T2DM used the TOMOCO™ and Fitbit in addition to the conventional diet/exercise therapy and anti-diabetic drug for 12 weeks. They were provided with feedback/advice by health care providers based on the TOMOCO™ and Fitbit records. The primary endpoint was the change in HbA1c from baseline to the end of the observation period. Data were expressed as mean ± standard deviation.

Results: Fifty-nine (96.7%) of the 61 participants (male, 42 [71.2%]; age, 60.1 ± 8.7 years; HbA1c level, 7.48 ± 0.37% at screening) completed the study. At the end of the observation period, the HbA1c was significantly reduced (- 0.41 ± 0.41%, p < 0.001). This trend was consistent across the preselected patient characteristics, including sex, age, and body mass index. However, it was more pronounced in the participants with earlier stages of behavioral changes defined by the transtheoretical model at baseline.

Conclusions: The unique features of TOMOCO™ in combination with Fitbit, together with conventional therapy, may promote a healthy lifestyle and thus contribute to improving HbA1c in people with T2DM.

Clinical trial registration: jRCT1070220007.

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生活方式改善支持应用程序与可穿戴设备相结合对日本 2 型糖尿病患者的效果：STEP-DM 研究。

简介尽管近年来支持糖尿病治疗的应用程序（App）和可穿戴设备的使用已迅速普及，但有关其影响的证据却很有限，尤其是在两者结合的情况下。TOMOCO™ 是一款支持改善生活方式的应用程序，其特点是根据编程算法进行交互式虚拟对话，引导用户实现改善生活方式的目标。我们假设，TOMOCO™ 与能准确跟踪用户活动水平的 Fitbit 相结合，将鼓励 2 型糖尿病（T2DM）患者改变生活方式，并在不改变传统疗法的情况下改善糖化血红蛋白（HbA1c）水平。因此，我们进行了本研究，以探讨这种组合对未达到血糖目标的日本 T2DM 患者的有效性：在这项单臂探索性研究中，T2DM 患者除了使用传统的饮食/运动疗法和抗糖尿病药物外，还使用了 TOMOCO™ 和 Fitbit，为期 12 周。医护人员会根据 TOMOCO™ 和 Fitbit 的记录向他们提供反馈/建议。主要终点是 HbA1c 从基线到观察期结束时的变化。数据以均数±标准差表示：61 名参与者中有 59 人（96.7%）完成了研究（男性，42 人 [71.2%]；年龄，60.1 ± 8.7 岁；筛查时 HbA1c 水平，7.48 ± 0.37%）。在观察期结束时，HbA1c 明显降低（- 0.41 ± 0.41%，P 结论）：TOMOCO™的独特功能与Fitbit的结合，再加上传统疗法，可促进健康的生活方式，从而有助于改善T2DM患者的HbA1c。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.