Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Eugeniahemmet T2, 171 76, Stockholm, Sweden.
Department of Biosciences and Nutrition, Karolinska Institutet, Stockholm, Sweden.
BMC Public Health. 2018 Jan 10;18(1):119. doi: 10.1186/s12889-018-5026-4.
Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2.
METHODS/DESIGN: The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months.
Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2.
ClinicalTrials.gov Identifier: NCT03053336 ; 7 Feb, 2017.
身体活动可以降低 2 型糖尿病相关并发症的风险。需要寻找可行且可扩展的策略，为初级保健中的患者提供支持健康生活方式的方案。DiaCert 研究的目的是评估一个数字医疗保健平台，以及为期 12 周的智能手机应用身体活动干预措施的效果，旨在增加身体活动（主要结果）和改善糖化血红蛋白（HbA1c）、血脂、血压、身体成分以及其他生活方式因素和 2 型糖尿病患者的整体健康水平。
方法/设计：DiaCert 研究是一项两臂、随机对照试验，将纳入 250 名 2 型糖尿病患者。在基线时，参与者以 1:1 的比例随机分为干预组，即使用智能手机应用 12 周，或对照组仅接受标准护理。使用 Actigraph GT3X 客观测量身体活动和久坐行为。生物标志物包括 HbA1c 和血脂在空腹血样中测量。人体测量学包括身高、体重、腰围和身体成分，以及许多生活方式因素，包括睡眠、饮食、自我效能和生活质量，通过广泛的问卷进行评估。测量在基线时和 3、6 和 12 个月后进行随访时进行。
使用新技术是弥合患者需求与医疗保健所能提供之间差距的一种方法。本研究评估了一种新的数字医疗保健平台，并将展示使用智能手机应用程序来促进日常步数是否是增加身体活动和改善 2 型糖尿病患者临床指标的有效且可行的方法。
ClinicalTrials.gov 标识符：NCT03053336；2017 年 2 月 7 日。
