Adelaide Medical School, Faculty of Health and Medical Science, University of Adelaide, Adelaide, South Australia, Australia.
Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Diabetes Obes Metab. 2023 Sep;25(9):2439-2446. doi: 10.1111/dom.15159. Epub 2023 Jun 29.
To determine whether a digital nudge soon after dinner reduces after-dinner snacking events as measured objectively by continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D).
This is a single-site micro-randomized trial (MRT). People with T2D, aged 18-75 years, managed with diet or a stable dose of oral antidiabetic medications for at least 3 months, and who habitual snack after dinner at least 3 nights per week, will be recruited. Picto-graphic nudges were designed by mixed research methods. After a 2-week lead-in phase to determine eligibility and snacking behaviours by a CGM detection algorithm developed by the investigators, participants will be micro-randomized daily (1:1) to a second 2-week period to either a picto-graphic nudge delivered-in-time (Intui Research) or no nudge. During lead-in and MRT phases, 24-hour glucose will be measured by CGM, sleep will be tracked by an under-mattress sleep sensor, and dinner timing will be captured daily by photographing the evening meal.
The primary outcome is the difference in the incremental area under the CGM curve between nudging and non-nudging days during the period from 90 minutes after dinner until 04:00 AM. Secondary outcomes include the effect of baseline characteristics on treatment, and comparisons of glucose peaks and time-in-range between nudging and non-nudging days. The feasibility of 'just-in-time' messaging and nudge acceptability will be evaluated, along with the analysis of sleep quality measures and their night-to-night variability.
This study will provide preliminary evidence of the impact of appropriately timed digital nudges on 24 -hour intertitial glucose levels resulting from altered after-dinner snacking in people with T2D. An exploratory sleep substudy will provide evidence of a bidirectional relationship between after-dinner snacking behaviour, glycaemia and sleep. Ultimately, this study will allow for the design of a future confirmatory study of the potential for digital nudging to improve health related behaviours and health outcomes.
通过连续血糖监测（CGM）客观测量，确定在 2 型糖尿病（T2D）患者中，晚餐后不久的数字提示是否会减少晚餐后的零食摄入事件。
这是一项单站点微随机试验（MRT）。将招募年龄在 18-75 岁之间的 T2D 患者，这些患者通过饮食或稳定剂量的口服抗糖尿病药物治疗至少 3 个月，并且每周至少有 3 晚习惯在晚餐后吃零食。使用混合研究方法设计了图片提示。在通过研究人员开发的 CGM 检测算法确定合格性和零食行为的 2 周导入期后，参与者将每天（1:1）微随机分配到第二个 2 周期，要么接受及时（Intui Research）的图片提示，要么不接受提示。在导入期和 MRT 期间，通过 CGM 测量 24 小时血糖，使用床垫下睡眠传感器跟踪睡眠，每天通过拍摄晚餐照片记录晚餐时间。
主要结果是从晚餐后 90 分钟到凌晨 04:00 之间，提示日与非提示日之间 CGM 曲线下面积的增量差异。次要结果包括基线特征对治疗的影响，以及提示日与非提示日之间血糖峰值和时间范围的比较。还将评估“及时”消息传递的可行性和提示可接受性，并分析睡眠质量测量及其夜间变异性。
本研究将提供关于适当时间的数字提示对 T2D 患者晚餐后零食引起的 24 小时间歇性血糖水平影响的初步证据。一项探索性睡眠子研究将提供晚餐后零食行为、血糖和睡眠之间双向关系的证据。最终，本研究将为未来数字提示改善与健康相关行为和健康结果的潜力的确认性研究设计提供依据。
